[Skip to Navigation]
Sign In
Figure 1.  Respondent-Reported Primary and Most Trusted Information Source on Clinical Trials
Respondent-Reported Primary and Most Trusted Information Source on Clinical Trials

All respondents include 3689 individuals; respondents who participated in a clinical trial, 199 individuals; respondents who were invited, but did not participate in a clinical trial, 230 individuals.

Figure 2.  Respondent Ranking of Factors Motivating Participation in Clinical Trials
Respondent Ranking of Factors Motivating Participation in Clinical Trials

All respondents include 3689 individuals; respondents who participated in a clinical trial, 199 individuals; respondents who were invited, but did not participate in a clinical trial, 230 individuals.

Table 1.  Respondent Demographic, Clinical, and Health Behavior–Related Characteristics by Invitation Status
Respondent Demographic, Clinical, and Health Behavior–Related Characteristics by Invitation Status
Table 2.  Multivariable Exploratory Analysis: Odds of Invitation to and Participation in a Clinical Trial by Respondent Demographic, Clinical, and Health Behavior–Related Characteristics
Multivariable Exploratory Analysis: Odds of Invitation to and Participation in a Clinical Trial by Respondent Demographic, Clinical, and Health Behavior–Related Characteristics
Table 3.  Invited Respondent Demographic, Clinical, and Health Behavior–Related Characteristics by Participation Status
Invited Respondent Demographic, Clinical, and Health Behavior–Related Characteristics by Participation Status
1.
ClinicalTrials.gov. Trends, charts, and maps. Accessed November 10, 2020. https://clinicaltrials.gov/ct2/resources/trends
2.
McDermott  MM, Newman  AB.  Preserving clinical trial integrity during the coronavirus pandemic.   JAMA. 2020;323(21):2135-2136. doi:10.1001/jama.2020.4689PubMedGoogle Scholar
3.
Averitt  AJ, Weng  C, Ryan  P, Perotte  A.  Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations.   NPJ Digit Med. 2020;3(1):67. doi:10.1038/s41746-020-0277-8PubMedGoogle Scholar
4.
Munk  NE, Knudsen  JS, Pottegård  A, Witte  DR, Thomsen  RW.  Differences between randomized clinical trial participants and real-world empagliflozin users and the changes in their glycated hemoglobin levels.   JAMA Netw Open. 2020;3(2):e1920949. doi:10.1001/jamanetworkopen.2019.20949PubMedGoogle Scholar
5.
Gillmeyer  KR, Rinne  ST, Walkey  AJ, Qian  SX, Wiener  RS.  How closely do clinical trial participants resemble “real-world” patients with groups 2 and 3 pulmonary hypertension? a structured review.   Ann Am Thorac Soc. 2020;17(6):779-783. doi:10.1513/AnnalsATS.202001-003RLPubMedGoogle Scholar
6.
Chen  MS  Jr, Lara  PN, Dang  JH, Paterniti  DA, Kelly  K.  Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.   Cancer. 2014;120(suppl 7):1091-1096. doi:10.1002/cncr.28575PubMedGoogle Scholar
7.
Copur  MS.  Inadequate awareness of and participation in cancer clinical trials in the community oncology setting.   Oncology (Williston Park). 2019;33(2):54-57.PubMedGoogle Scholar
8.
Kennedy-Martin  T, Curtis  S, Faries  D, Robinson  S, Johnston  J.  A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.   Trials. 2015;16(1):495. doi:10.1186/s13063-015-1023-4PubMedGoogle Scholar
9.
Unger  JM, Cook  E, Tai  E, Bleyer  A.  The role of clinical trial participation in cancer research: barriers, evidence, and strategies.   Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.1200/EDBK_156686PubMedGoogle Scholar
10.
Langford  A, Resnicow  K, An  L.  Clinical trial awareness among racial/ethnic minorities in HINTS 2007: sociodemographic, attitudinal, and knowledge correlates.   J Health Commun. 2010;15(suppl 3):92-101.PubMedGoogle Scholar
11.
Leiter  A, Diefenbach  MA, Doucette  J, Oh  WK, Galsky  MD.  Clinical trial awareness: changes over time and sociodemographic disparities.   Clin Trials. 2015;12(3):215-223. doi:10.1177/1740774515571917PubMedGoogle Scholar
12.
Garza  MA, Quinn  SC, Li  Y,  et al.  The influence of race and ethnicity on becoming a human subject: factors associated with participation in research.   Contemp Clin Trials Commun. 2017;7:57-63. doi:10.1016/j.conctc.2017.05.009PubMedGoogle Scholar
13.
Research America. Clinical trials: survey data of minority populations. Accessed August 25, 2021. https://ictr.johnshopkins.edu/wp-content/uploads/2017/12/Research-America-July-2017.pdf
14.
Research America. Public perception of clinical trials. Accessed August 25, 2021. https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf
15.
National Cancer Institute. Health Information National Trends Survey. Accessed November 6, 2020. https://hints.cancer.gov/
16.
Finney Rutten  LJ, Blake  KD, Skolnick  VG, Davis  T, Moser  RP, Hesse  BW.  Data resource profile: the National Cancer Institute’s Health Information National Trends Survey (HINTS).   Int J Epidemiol. 2020;49(1):17-17j. doi:10.1093/ije/dyz083PubMedGoogle Scholar
17.
Clark  LT, Watkins  L, Piña  IL,  et al.  Increasing diversity in clinical trials: overcoming critical barriers.   Curr Probl Cardiol. 2019;44(5):148-172. doi:10.1016/j.cpcardiol.2018.11.002PubMedGoogle Scholar
18.
Chu  SH, Kim  EJ, Jeong  SH, Park  GL.  Factors associated with willingness to participate in clinical trials: a nationwide survey study.   BMC Public Health. 2015;15(1):10. doi:10.1186/s12889-014-1339-0PubMedGoogle Scholar
19.
Anderson  A, Borfitz  D, Getz  K.  Global public attitudes about clinical research and patient experiences with clinical trials.   JAMA Netw Open. 2018;1(6):e182969. doi:10.1001/jamanetworkopen.2018.2969PubMedGoogle Scholar
20.
Willis  GB.  Cognitive Interviewing: A Tool for Improving Questionnaire Design. Sage Publications; 2004.
21.
von Elm  E, Altman  DG, Egger  M, Pocock  SJ, Gøtzsche  PC, Vandenbroucke  JP; STROBE Initiative.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.   Ann Intern Med. 2007;147(8):573-577.PubMedGoogle Scholar
22.
Elliott  MN, Zaslavsky  AM, Goldstein  E,  et al.  Effects of survey mode, patient mix, and nonresponse on CAHPS hospital survey scores.   Health Serv Res. 2009;44(2 Pt 1):501-518.PubMedGoogle Scholar
23.
US Department of Agriculture. Rural-Urban Commuting Codes. Accessed August 25, 2021. https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes/
24.
Saitz  R.  Clinical practice: unhealthy alcohol use.   N Engl J Med. 2005;352(6):596-607.PubMedGoogle Scholar
25.
Cohen  J.  A power primer.   Psychol Bull. 1992;112(1):155-159. doi:10.1037/0033-2909.112.1.155PubMedGoogle Scholar
26.
Ludmir  EB, Mainwaring  W, Lin  TA,  et al.  Factors associated with age disparities among cancer clinical trial participants.   JAMA Oncol. 2019;5(12):1769-1773. doi:10.1001/jamaoncol.2019.2055PubMedGoogle Scholar
27.
Unger  JM, Hershman  DL, Albain  KS,  et al.  Patient income level and cancer clinical trial participation.   J Clin Oncol. 2013;31(5):536-542. doi:10.1200/JCO.2012.45.4553PubMedGoogle Scholar
28.
Lind  KD. Excluding older, sicker patients from clinical trials: issues, concerns, and solutions. AARP Public Policy Institute. Accessed August 25, 2021. https://www.aarp.org/content/dam/aarp/research/public_policy_institute/health/2011/i57.pdf
29.
National Cancer Institute. Community Oncology Research Program (NCORP). Accessed December 17, 2020. https://ncorp.cancer.gov/
30.
Wendler  D, Kington  R, Madans  J,  et al.  Are racial and ethnic minorities less willing to participate in health research?   PLoS Med. 2006;3(2):e19. doi:10.1371/journal.pmed.0030019PubMedGoogle Scholar
31.
Langford  AT, Resnicow  K, Dimond  EP,  et al.  Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program.   Cancer. 2014;120(6):877-884. doi:10.1002/cncr.28483PubMedGoogle Scholar
32.
Joseph  G, Dohan  D.  Diversity of participants in clinical trials in an academic medical center: the role of the ‘Good Study Patient?’.   Cancer. 2009;115(3):608-615. doi:10.1002/cncr.24028PubMedGoogle Scholar
33.
Niranjan  SJ, Martin  MY, Fouad  MN,  et al.  Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials.   Cancer. 2020;126(9):1958-1968. doi:10.1002/cncr.32755PubMedGoogle Scholar
34.
NIH Revitalization Act of 1993, S1, 103rd Congress (1993-1994). Accessed August 25, 2021. https://www.congress.gov/bill/103rd-congress/senate-bill/1
35.
St Germain  D, Denicoff  AM, Dimond  EP,  et al.  Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual.   J Oncol Pract. 2014;10(2):e73-e80. doi:10.1200/JOP.2013.001194PubMedGoogle Scholar
36.
Denicoff  AM, McCaskill-Stevens  W, Grubbs  SS,  et al.  The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.   J Oncol Pract. 2013;9(6):267-276. doi:10.1200/JOP.2013.001119PubMedGoogle Scholar
37.
US Food and Drug Administration. Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs: guidance for industry. November 2020. Accessed July 25, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
38.
Unger  JM, Hershman  DL, Till  C,  et al.  “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials.   J Natl Cancer Inst. 2021;113(3):244-257. doi:10.1093/jnci/djaa155PubMedGoogle Scholar
39.
Saphner  T, Marek  A, Homa  JK, Robinson  L, Glandt  N.  Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status.   Contemp Clin Trials. 2021;103:106315. doi:10.1016/j.cct.2021.106315PubMedGoogle Scholar
40.
Scharff  DP, Mathews  KJ, Jackson  P, Hoffsuemmer  J, Martin  E, Edwards  D.  More than Tuskegee: understanding mistrust about research participation.   J Health Care Poor Underserved. 2010;21(3):879-897. doi:10.1353/hpu.0.0323PubMedGoogle Scholar
41.
Senft  N, Hamel  LM, Manning  MA,  et al.  Willingness to discuss clinical trials among Black vs White men with prostate cancer.   JAMA Oncol. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697PubMedGoogle Scholar
42.
Metzl  JM, Hansen  H.  Structural competency: theorizing a new medical engagement with stigma and inequality.   Soc Sci Med. 2014;103:126-133. doi:10.1016/j.socscimed.2013.06.032PubMedGoogle Scholar
43.
Metzl  JM, Maybank  A, De Maio  F.  Responding to the COVID-19 pandemic: the need for a structurally competent health care system.   JAMA. 2020;324(3):231-232. doi:10.1001/jama.2020.9289PubMedGoogle Scholar
44.
Brooks  SE, Muller  CY, Robinson  W,  et al.  Increasing minority enrollment onto clinical trials: practical strategies and challenges emerge from the NRG Oncology Accrual Workshop.   J Oncol Pract. 2015;11(6):486-490. doi:10.1200/JOP.2015.005934PubMedGoogle Scholar
45.
Wilkins  CH, Mapes  BM, Jerome  RN, Villalta-Gil  V, Pulley  JM, Harris  PAJHA.  Understanding what information is valued by research participants, and why.   Health Aff (Millwood). 2019;38(3):399-407. doi:10.1377/hlthaff.2018.05046PubMedGoogle Scholar
46.
Fouad  MN, Acemgil  A, Bae  S,  et al.  Patient navigation as a model to increase participation of African Americans in cancer clinical trials.   J Oncol Pract. 2016;12(6):556-563. doi:10.1200/JOP.2015.008946PubMedGoogle Scholar
47.
Durant  RW, Wenzel  JA, Scarinci  IC,  et al.  Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).   Cancer. 2014;120(suppl 7):1097-1105. doi:10.1002/cncr.28574PubMedGoogle Scholar
48.
Lloyd Wade  J  III, Petrelli  NJ, McCaskill-Stevens  W.  Cooperative group trials in the community setting.   Semin Oncol. 2015;42(5):686-692. doi:10.1053/j.seminoncol.2015.07.011PubMedGoogle Scholar
49.
National Institute on Drug Abuse. Clinical Trials Network (CTN). Accessed March 8, 2021. https://www.drugabuse.gov/about-nida/organization/cctn/clinical-trials-network-ctn
50.
National Institutes of Health Collaboratory. NIH Collaboratory Distributed Research Network (DRN). Accessed March 8, 2021. https://rethinkingclinicaltrials.org/nih-collaboratory-drn/
51.
Hamel  LM, Penner  LA, Albrecht  TL, Heath  E, Gwede  CK, Eggly  S.  Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer.   Cancer Control. 2016;23(4):327-337. doi:10.1177/107327481602300404PubMedGoogle Scholar
52.
Howerton  MW, Gibbons  MC, Baffi  CR,  et al.  Provider roles in the recruitment of underrepresented populations to cancer clinical trials.   Cancer. 2007;109(3):465-476. doi:10.1002/cncr.22436PubMedGoogle Scholar
53.
Brown  R, Bylund  C. Theoretical models of communication skills training. In: Kissane  D, Bultz  B, Butow  P, Finlay  I, eds.  Handbook of Communication in Oncology and Palliative Care. Oxford University Press; 2011:27-40.
54.
Meropol  NJ, Wong  Y-N, Albrecht  T,  et al.  Randomized trial of a web-based intervention to address barriers to clinical trials.   J Clin Oncol. 2016;34(5):469-478. doi:10.1200/JCO.2015.63.2257PubMedGoogle Scholar
55.
Massett  HA, Dilts  DM, Bailey  R,  et al.  Raising public awareness of clinical trials: development of messages for a national health communication campaign.   J Health Commun. 2017;22(5):373-385. doi:10.1080/10810730.2017.1290715PubMedGoogle Scholar
56.
Occa  A, Morgan  SE, Potter  JE.  Underrepresentation of Hispanics and other minorities in clinical trials: recruiters’ perspectives.   J Racial Ethn Health Disparities. 2018;5(2):322-332. doi:10.1007/s40615-017-0373-xPubMedGoogle Scholar
57.
Torres  S, de la Riva  EE, Tom  LS,  et al.  The development of a communication tool to facilitate the cancer trial recruitment process and increase research literacy among underrepresented populations.   J Cancer Educ. 2015;30(4):792-798. doi:10.1007/s13187-015-0818-zPubMedGoogle Scholar
58.
Hoffner  B, Bauer-Wu  S, Hitchcock-Bryan  S, Powell  M, Wolanski  A, Joffe  S.  “Entering a Clinical Trial: Is it Right for You?”: a randomized study of The Clinical Trials Video and its impact on the informed consent process.   Cancer. 2012;118(7):1877-1883. doi:10.1002/cncr.26438PubMedGoogle Scholar
59.
Flory  J, Emanuel  E.  Interventions to improve research participants’ understanding in informed consent for research: a systematic review.   JAMA. 2004;292(13):1593-1601. doi:10.1001/jama.292.13.1593PubMedGoogle Scholar
60.
Nipp  RD, Hong  K, Paskett  ED.  Overcoming barriers to clinical trial enrollment.   Am Soc Clin Oncol Educ Book. 2019;39:105-114. doi:10.1200/EDBK_243729PubMedGoogle Scholar
61.
Nipp  RD, Lee  H, Powell  E,  et al.  Financial burden of cancer clinical trial participation and the impact of a cancer care equity program.   Oncologist. 2016;21(4):467-474. doi:10.1634/theoncologist.2015-0481PubMedGoogle Scholar
62.
Unger  JM, Fleury  ME.  Reimbursing patients for participation in cancer clinical trials.   JAMA Oncol. 2019;5(7):932-934. doi:10.1001/jamaoncol.2019.0141PubMedGoogle Scholar
63.
US Food and Drug Administration. Payments and reimbursements to research subjects—guidance for institutional review boards and clinical investigators. January 2018. Accessed August 26, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects
64.
Winkfield  KM, Phillips  JK, Joffe  S, Halpern  MT, Wollins  DS, Moy  B.  Addressing financial barriers to patient participation in clinical trials: ASCO policy statement.   J Clin Oncol. 2018;36(33):3331-3339. doi:10.1200/JCO.18.01132PubMedGoogle Scholar
65.
Cancer Action Network. Barriers to patient enrollment in therapeutic clinical trials for cancer. April 11, 2018. Accessed August 26, 2021. https://www.fightcancer.org/policy-resources/clinical-trial-barriers
66.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill, 2019, 115th Congress (2018-2019). Accessed September 1, 2021. https://www.congress.gov/115/crpt/hrpt862/CRPT-115hrpt862.pdf
67.
Clinical Treatment Act, HR 913, 116th Congress (2019-2020). Accessed August 26, 2021. https://www.congress.gov/bill/116th-congress/house-bill/913
68.
Bernstein  SL, Feldman  J.  Incentives to participate in clinical trials: practical and ethical considerations.   Am J Emerg Med. 2015;33(9):1197-1200. doi:10.1016/j.ajem.2015.05.020PubMedGoogle Scholar
69.
Maitland  A, Lin  A, Cantor  D,  et al.  A nonresponse bias analysis of the Health Information National Trends Survey (HINTS).   J Health Commun. 2017;22(7):545-553. doi:10.1080/10810730.2017.1324539PubMedGoogle Scholar
Original Investigation
Health Policy
September 29, 2021

Demographic and Health Behavior Factors Associated With Clinical Trial Invitation and Participation in the United States

Author Affiliations
  • 1Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland
JAMA Netw Open. 2021;4(9):e2127792. doi:10.1001/jamanetworkopen.2021.27792
Key Points

Question  What person-level factors are associated with US adults’ invitation to and participation in clinical trials?

Findings  In this cross-sectional study of 3689 adults, 9% were invited to participate in a clinical trial, and of those, 47% participated. Respondents had higher odds of clinical trial invitation if they were non-Hispanic Black, college educated, single, or urban-dwelling or had medical conditions; non-Hispanic Black respondents had lower odds of clinical trial participation.

Meaning  In this study, clinical trial invitation and participation differed by person-level demographic and clinical characteristics, reinforcing the need for strategies encouraging generalizable and equitable translation of research to practice.

Abstract

Importance  Representative enrollment in clinical trials is critical to ensure equitable and effective translation of research to practice, yet disparities in clinical trial enrollment persist.

Objective  To examine person-level factors associated with invitation to and participation in clinical trials.

Design, Setting, and Participants  This cross-sectional study analyzed responses from 3689 US adults who participated in the nationally representative Health Information National Trends Survey, collected February through June 2020 via mailed questionnaires.

Exposures  Demographic, clinical, and health behavior–related characteristics.

Main Outcomes and Measures  History of invitation to and participation in a clinical trial, primary information sources, trust in information sources, and motives for participation in clinical trials were described. Respondent characteristics are presented as absolute numbers and weighted percentages. Associations between respondent demographic, clinical, and health behavior–related characteristics and clinical trial invitation and participation were estimated using survey-weighted logistic regression models.

Results  The median (IQR) age of the 3689 respondents was 48 (33-61) years, and most were non-Hispanic White individuals (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]). Overall, 439 respondents (9%) had been invited to participate in any clinical trial. Respondents with increased odds of invitation were non-Hispanic Black compared with non-Hispanic White (adjusted odds ratio [aOR], 1.85; 95% CI, 1.13-3.02), had greater than a high school education compared with less than high school education (eg, ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), were single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and had at least 1 medical condition compared to none (eg, 1 medical condition: aOR, 2.25; 95% CI, 1.32-3.82). Respondents residing in rural vs urban areas had 77% decreased odds of invitation to a clinical trial (aOR 0.33; 95% CI 0.17-0.65). Of invited respondents, 199 (47%) participated. Compared with non-Hispanic White respondents, non-Hispanic Black respondents had 72% decreased odds of clinical trial participation (aOR, 0.28; 95% CI, 0.09-0.87). Respondents most frequently reported “health care providers” as the first and most trusted source of clinical trial information (first source: 2297 [59%]; most trusted source: 2597 [70%]). The most frequently reported motives for clinical trials participation were “wanting to get better” (2294 [66%]) and the standard of care not being covered by insurance (1448 [41%]).

Conclusions and Relevance  The findings of this study suggest that invitation to and participation in clinical trials may differ by person-level demographic and clinical characteristics. Strategies toward increasing trial invitation and participation rates across diverse patient populations warrant further research to ensure equitable translation of clinical benefits from research to practice.

Introduction

Evidence-based evaluation of new health care treatments and interventions via clinical trials is critical for improving individual and population health. As of April 2021, ClinicalTrials.gov listed 291 087 ongoing trials, including 158 827 drug or biologic interventions and 96 449 behavioral interventions.1,2 However, clinical trial participants infrequently represent the real-world population in which the intervention will be applied.3,4 Several patient population subgroups remain underrepresented in trials, including older adults, people who belong to racial or ethnic minority groups, persons with multiple comorbid conditions, and individuals residing in rural locations.5-7 Disparities between trial participants and real-world populations are problematic, since results from these trials provide the evidence base for real-world clinical practice guidelines and public health services.8

Previous research has shown that person-level factors, such as sociodemographic characteristics, may affect whether individuals are invited to participate in clinical trials, while motivations and beliefs may affect decisions to participate if invited.9-14 Much of the existing literature on trials tends to be condition-specific, focused on participation rather than invitation, and specific to subpopulations of the US public. To build on the existing literature base, investigation into the larger US public’s recent invitation to, participation in, and motivations surrounding clinical trials is needed. This study seeks to understand person-level factors associated with invitation to and participation in clinical trials in a large, nationally representative sample of US adults. We also describe respondent primary trial information sources, trust in information sources, and motives for participation in clinical trials to inform future efforts addressing disparities in clinical trial invitation and participation.

Methods
Study Design and Sample

This cross-sectional study used data from the National Cancer Institute’s Health Information National Trends Survey (HINTS) 5 Cycle 4, collected February through June 2020 via mailed questionnaires. HINTS is a publicly available, cross-sectional, nationally representative survey of civilian, noninstitutionalized US adults that assesses knowledge of, attitudes toward, and use of health-related information.15,16 HINTS 5 Cycle 4 included 7 new questions regarding clinical trials (eFigure in the Supplement).15 Initial constructs and associated items were included based on published literature representing a range of clinical conditions,9,17 racial and ethnic groups,17 and nationalities.17-19 Two rounds of cognitive testing20 were conducted with a diverse sample of 30 individuals (15 per round). Results informed the refinement of items and response options for inclusion in the survey. A plain language definition of clinical trials with 2 examples was included to standardize respondent interpretation and to specify that trials include drug and behavioral interventions. HINTS data are deidentified and thus exempt from review by the US National Institutes of Health Office of Human Subjects Research Protections. Respondents provided consent to participate in HINTS. This study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines.21

Primary Outcome: Clinical Trial Invitation and Participation

Invitation to a clinical trial was assessed with a single yes or no item, “Have you ever been invited to participate in a clinical trial?” If the respondent answered yes, they were asked the single yes or no item, “Did you participate in the clinical trial?”

Secondary Outcomes: Information Sources, Trust, and Motives for Participation in Clinical Trials

Respondents were asked about their current knowledge of clinical trials, where they would first go to get information about a hypothetical trial, and who they would most trust as a source of information about a hypothetical trial. Respondents were also asked to rate factors (eg, helping others, payment for participation) that would influence their decision to participate in a hypothetical clinical trial on a 4-point scale (a lot, somewhat, a little, not at all). Influential factors in trial decision-making were dichotomized as a lot vs the combined scores of somewhat, a little, and not at all.22 Separated scores for all response options are shown in eTable 1 in the Supplement.

Covariables: Respondent Characteristics

Self-reported demographic, clinical, and health behavior–related respondent characteristics were included from the HINTS survey data for descriptive comparison and multivariable analysis. Demographic variables included age, sex, race and ethnicity (race: White, Black or African American, American Indian or Alaska Native, Asian Indian, Chinese, Filipino, Japanese, Korean, Vietnamese, other Asian, Native Hawaiian, Guamanian or Chamorro, Samoan, other Pacific Islander; ethnicity: not of Hispanic, Latino/a, or Spanish origin; Mexican, Mexican American, Chicano/a; Puerto Rican; Cuban; another Hispanic, Latino/a, or Spanish origin), education, feelings about present income, marital status, rural or urban residence,23 Census region, employment status, and health insurance status. Clinical variables included number and type of diagnosed medical conditions and self-reported health. Health behavior–related variables included smoking status, hazardous drinking,24 weekly exercise, and annual health care visits.

Statistical Analysis

All analyses were weighted to provide nationally representative estimates using complex survey methodology with jackknife replicate weights for accurate standard errors.15 Mean differences, or effect sizes, were calculated using unweighted Cohen d or Cramer V to determine the magnitude of associations in bivariate associations.25 Associations between respondent demographic, clinical, and health behavior–related characteristics and clinical trial invitation and participation were estimated using adjusted odds ratios (aOR) and 95% CIs from exploratory survey-weighted logistic regression models. All covariables were included in the model exploring clinical trial invitation. Due to reduced sample size limiting power to determine magnitude of bivariate associations in the model estimating clinical trial participation, covariables were restricted based on past research demonstrating differential rates of clinical trial participation associated with age, race and ethnicity, sex, education, income, urban or rural residence, health insurance status, and health status.26-30 Covariable multicollinearity was examined using the variance inflation factor. Sensitivity analyses were conducted excluding respondents who reported knowing nothing about clinical trials. Trial participation motives, information seeking, and trust were described by (1) the overall sample, (2) respondents who participated in a clinical trial, and (3) respondents who were invited but did not participate in a clinical trial. All analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).

Results
Sample Characteristics

A total of 15 347 HINTS 5 Cycle 4 surveys were mailed. Of mailed surveys, 3977 were returned, 3865 were eligible for analysis (weighted response rate, 37%), and 3689, with complete information on clinical trial items, were included in our sample. The 176 respondents excluded because of missing trial invitation status more frequently had less education (eTable 2 in the Supplement). Of the 3689 included respondents, half were female (2107 [50%]), the median (IQR) age was 48 (33-61) years, and most were non-Hispanic White (2063 [59%]; non-Hispanic Black, 452 [10%]; Hispanic, 521 [14%]), had more than a high school degree (2656 [68%]), were employed (1809 [58%]), and had at least 1 medical condition (2535 [61%]) (Table 1).

Characteristics Associated With Clinical Trial Invitation and Participation

Overall, 439 respondents (9%) reported being invited to participate in a clinical trial (Table 1). In exploratory models, respondent factors associated with increased odds of reported clinical trial invitation included being non-Hispanic Black compared with non-Hispanic White (aOR, 1.85; 95% CI, 1.13-3.02), having some college education or a college degree or higher compared with less than high school education (some college: aOR, 2.48; 95% CI, 1.07-5.77; ≥college degree: aOR, 4.84; 95% CI, 1.89-12.39), being single compared with married or living as married (aOR, 1.68; 95% CI, 1.04-2.73), and having at least 1 more medical condition compared with none (1 condition: aOR, 2.25; 95% CI, 1.32-3.82; 2 conditions: aOR, 2.67; 95% CI, 1.56-4.57; ≥3: aOR, 3.76; 95% CI, 2.01-7.03) (Table 2). Conversely, respondents residing in a rural area had 77% decreased odds of invitation to a clinical trial than those residing in an urban area (aOR 0.33; 95% CI 0.17-0.65).

Of those invited to a clinical trial, 199 respondents (47%) reported participating (Table 3). In models estimating odds of reported clinical trial participation, respondents who were non-Hispanic Black compared with non-Hispanic White had 72% decreased odds of participation after invitation (aOR, 0.28; 95% CI, 0.09-0.87) (Table 2). In sensitivity analyses excluding 1345 respondents who reported knowing nothing about clinical trials, education and marital status were no longer associated with trial invitation, while dual-eligible beneficiaries had higher odds of invitation compared with those with private insurance (eTable 3 in the Supplement). Trial participation model results were similar.

Information Sources, Trust, and Motives for Clinical Trial Participation Among All Respondents

When respondents were asked to imagine a need for clinical trial information, “health care providers” were most frequently reported as their first source of information (2297 [59%]), followed by the internet (644 [21%]) (Figure 1A). “Health care providers” were also reported most frequently as respondents most trusted information source (2597 [70%]), followed by health organizations or groups (456 [13%]) (Figure 1B). Among those invited to a clinical trial, primary information sources differed between those who did and did not participate. Respondents who reported participating in clinical trials, compared with those who did not report participation, less frequently reported physicians (94 of 199 [46%] vs 145 of 230 [57%]) and more frequently reported the internet as a first source of information (44 [28%] vs 34 [18%]). Among those invited to a clinical trial, trust in information sources did not differ substantially between those who did and did not participate.

When all respondents were asked to imagine being invited to a clinical trial for any health issue, the most influential factors in the decision to participate in a trial included “wanting to get better” (2294 [66%]), the standard of care not being covered by insurance (1448 [41%]), and the chance to try a new kind of care (1085 [30%] (Figure 2). Among those invited to a clinical trial, influential factors in the decision to participate differed between those who did and did not participate. Respondents who reported participating in trials, compared with those who did not report participation, were more motivated by helping other people (98 of 199 [45%] vs 70 of 230 [29%]) and getting paid (63 [39%] vs 49 [27%]).

Discussion

Results of this nationally representative survey suggest that approximately 1 in 10 Americans report being invited to participate in a clinical trial, with a little less than half of those invited reporting participation. In multivariable models, respondents had higher odds of clinical trial invitation if they were non-Hispanic Black, had a college education, were single, were urban-dwelling, or had at least 1 medical condition. However, non-Hispanic Black respondents had lower odds of self-reported trial participation than non-Hispanic White respondents. These results reinforce the need for future research promoting effective clinical trial communication via health care professionals and the internet, as these were identified as important sources of clinical trial information. Our results also highlight a need for further research on ameliorative, financial, and altruistic factors as potential engagement strategies for trial participation.

Non-Hispanic Black respondents in our study had higher odds of reported invitation to clinical trials than non-Hispanic White respondents. These results contrast with prior literature proposing trial design- and researcher-level explanations for racial and ethnic disparities in clinical trial representation, such as restrictive eligibility criteria and researcher bias, that may hinder equitable invitation.31-33 Our results may reflect researcher-level uptake of initiatives to increase the diversity of clinical trial participants. Since the 1993 National Institutes of Health (NIH) Revitalization Act34 mandating inclusion of racial and ethnic minority groups in NIH-funded research, increased attention has been placed on greater clinical trial inclusivity.35,36 More recently, the US Food and Drug Administration (FDA) issued recommendations for greater inclusion of certain segments of the population, including those identifying as Black, Indigenous, or another minority racial or ethnic group as well as analysis of study results by race and ethnicity.37 Continued commitment to equity in trial invitation may help ensure equitable representation in clinical trials.

Despite greater odds of reported invitation to clinical trials in this study, non-Hispanic Black respondents had lower odds of reported participation in clinical trials than non-Hispanic White respondents. This contrasts with previous work showing Black and White individuals enroll in clinical trial at similar rates if invited.30,31,38,39 Although our study controlled for comorbidity status, health care engagement, and financial burden, other items influencing barriers to clinical trial participation, such as ineligibility or lack of access, may result in lower participation rates. Furthermore, historical research mistreatment toward the Black community, current disparities in health care access and quality, and negative encounters with health care professionals may also affect trial participation.40,41 Multilevel institutional efforts addressing eligibility, access, and systemic racism are needed to decrease racial and ethnic health inequities in clinical trial participation, such as diversifying the health care workforce, increasing community engagement, enhancing transparency of research practices, and training health care professionals in structural competency, defined as identifying and clinically addressing structural drivers of health inequity.42-45 Building an environment of trust and facilitating effective communication between patients and the health care system could also be helpful. Participation in therapeutic cancer clinical trials nearly doubled among Black patients receiving trial education by nonclinical patient navigators compared with patients not receiving navigation services.46 Other multilevel efforts, such as information dissemination via community health advisors,47 warrant further research.

In our study, respondents residing in rural compared with urban areas had decreased odds of invitation to clinical trials. These results may stem from the historical lack of trial availability for individuals receiving medical care in rural settings. Recent efforts have focused on remediating this discrepancy. Current NIH-funded initiatives expand trial availability in community-based settings by dismantling patient-level barriers to trial participation related to residing far from care settings. The National Cancer Institute Community Oncology Research Program,29,48 the National Institute on Drug Abuse Clinical Trials Network,49 and the NIH Collaboratory Distributed Research Network50 bring more research into community settings, offering increased opportunities for participation in clinical trials closer to their residence. To ensure equitable access to trials, increased awareness of trial availability is needed, especially among underserved and diverse patient populations.

Health care professionals may serve as the greatest opportunity to increase clinical trial enrollment, given that they were both the first and most trusted clinical trial information source reported by 59% and 70% of all respondents, respectively. This suggests patient-clinician communication is key to raising patient awareness of and participation in clinical trials. Clinicians must first be aware of actively recruiting trials as well as their eligibility criteria to communicate potential enrollment with their patients.51-53 Furthermore, communicating complex trial protocols to patients with differing health literacy is challenging because of time-related constraints during clinical encounters.33 The internet was reported as a trustworthy source of information by 28% of respondents, suggesting future research in web-based education and counseling to increase efficiency of in-clinic trial communications.54 Culturally appropriate, plain-language tools could also facilitate patient-clinician communication, especially for patients without internet access or with low health literacy.55,56 Historically underrepresented potential research participants found simple paper flashcards to be effective communication tools given that they quickly communicate research information.57 Other modalities, like video, do not increase trial knowledge, but help facilitate extended discussions between patients and clinicians about clinical trial participation.58,59

Financial incentives were commonly reported by study respondents as influential in their clinical trial participation decision, including having treatment payment covered and getting paid for trial participation. Although payment for treatment and routine care received while participating in trials may act as a facilitator to clinical trial participation, indirect costs related to trial participation, such as transportation to the clinic or time off work to participate, may act as barriers. Barriers related to indirect trial expenses may explain why respondents enrolled in Medicaid or dually enrolled were more often invited to trials but less often participated. Our results are consistent with previous studies regarding patient financial issues surrounding trial participation.27,60,61 To potentially remove financial barriers to participation, recent recommendations from advocacy, research, and governmental organizations, including the FDA, have encouraged patient reimbursement for direct and indirect trial-related costs.62-66 In December 2020, Congress passed the Clinical Treatment Act, which requires Medicaid to cover routine clinical care costs associated with clinical trial participation,67 removing some financial barriers and furthering representation of disparate patient groups. However, quantification of and reimbursement for indirect trial costs in a trial environment remains unclear. Furthermore, trialists should ensure financial incentives are ethical and do not result in coercion or undue influence for study participation.68 Efforts to reduce financial hardship for individuals willing to participate in clinical trials should be considered an ethical priority for trialists to increase equitable access for all.

Limitations

The results from our study should be considered within the context of several limitations. The data for this study were subject to selection biases including mailed survey coverage error, nonresponse, and voluntary response potentially associated with likelihood to participate in a clinical trial. However, HINTS data weights were specifically calibrated to compensate for these biases.69 Data were self-reported by HINTS respondents and therefore subject to recall bias. Although items were developed using 2 rounds of cognitive testing to maximize understandability, variation in respondent interpretation of these questions is possible. In particular, rates of invitation to clinical trials may be overreported in the current data, as respondents may have difficulty differentiating invitation to a clinical trial from prescreening or eligibility assessment for a trial, a more general discussion of a trial, or even invitation to other health research (eg, survey or qualitative studies). Future efforts to decrease measurement error are needed for the development of interventions targeting equitable clinical trial invitation and enrollment. The complexity surrounding the multilevel factors influencing clinical trial invitation and participation was not captured. Our results may be influenced by the low general knowledge of clinical trials in our sample, especially since this survey was fielded outside of a usual care setting. However, sensitivity analyses excluding respondents reporting no knowledge of clinical trials revealed similar results in our multivariable models. Respondents reported financial access to standard of care medications as a primary motivator to trial participation. This may be a uniquely US phenomenon given the high cost of health care, even for individuals with insurance. Because our survey was fielded during spring 2020, results may also be influenced by increased awareness of trials by the US public due to the COVID-19 pandemic. However, rates of invitation and participation were similar for surveys returned both before and after March 11, 2020, the date the pandemic was declared. Additionally, our results are not disease specific but rather provide a generalized snapshot of clinical trial engagement nationwide.

Conclusions

In this nationally representative sample, approximately 1 in 10 respondents reported being invited to participate in a clinical trial, and nearly half of those respondents reported participating in a trial after invitation. Self-reported clinical trial invitation was associated with respondent race and ethnicity, residence, education, marital status, and comorbidity status, while self-reported trial participation was associated with race and ethnicity alone. Respondents reported “health care providers” and the internet as important sources of clinical trial information, and health improvement, financial incentives, and altruism as key motivations for clinical trial participation. Strategies for increasing trial participation rates across diverse patient populations, such as increasing trial availability across diverse geographic care settings, facilitating patient-clinician trial information communication, and providing financial reimbursement for trial participation, warrant further research to ensure equitable translation of clinical benefits from research to practice.

Back to top
Article Information

Accepted for Publication: July 30, 2021.

Published: September 29, 2021. doi:10.1001/jamanetworkopen.2021.27792

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Williams CP et al. JAMA Network Open.

Corresponding Author: Courtney P. Williams, DrPH, Division of Cancer Control and Population Sciences, National Cancer Institute, 9609 Medical Center Dr, Rockville, MD 20850 (courtney.williams@nih.gov).

Author Contributions: Dr Williams had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: Williams, Senft Everson, Shelburne.

Drafting of the manuscript: Williams, Norton.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Williams, Senft Everson.

Administrative, technical, or material support: Shelburne.

Supervision: Senft Everson, Norton.

Conflict of Interest Disclosures: None reported.

Disclaimer: The opinions expressed by the authors are their own and this material should not be interpreted as representing the official viewpoint of the US Department of Health and Human Services, the National Institutes of Health, or the National Cancer Institute.

Additional Contributions: We would like to acknowledge Jennifer Alvidrez, PhD, David Chambers, DPhil, Andrea Denicoff, RN, MS, ANP, and Holly Massett, PhD, all of the National Institutes of Health, for their thoughtful input on earlier versions of the manuscript. No compensation was provided for their assistance.

References
1.
ClinicalTrials.gov. Trends, charts, and maps. Accessed November 10, 2020. https://clinicaltrials.gov/ct2/resources/trends
2.
McDermott  MM, Newman  AB.  Preserving clinical trial integrity during the coronavirus pandemic.   JAMA. 2020;323(21):2135-2136. doi:10.1001/jama.2020.4689PubMedGoogle Scholar
3.
Averitt  AJ, Weng  C, Ryan  P, Perotte  A.  Translating evidence into practice: eligibility criteria fail to eliminate clinically significant differences between real-world and study populations.   NPJ Digit Med. 2020;3(1):67. doi:10.1038/s41746-020-0277-8PubMedGoogle Scholar
4.
Munk  NE, Knudsen  JS, Pottegård  A, Witte  DR, Thomsen  RW.  Differences between randomized clinical trial participants and real-world empagliflozin users and the changes in their glycated hemoglobin levels.   JAMA Netw Open. 2020;3(2):e1920949. doi:10.1001/jamanetworkopen.2019.20949PubMedGoogle Scholar
5.
Gillmeyer  KR, Rinne  ST, Walkey  AJ, Qian  SX, Wiener  RS.  How closely do clinical trial participants resemble “real-world” patients with groups 2 and 3 pulmonary hypertension? a structured review.   Ann Am Thorac Soc. 2020;17(6):779-783. doi:10.1513/AnnalsATS.202001-003RLPubMedGoogle Scholar
6.
Chen  MS  Jr, Lara  PN, Dang  JH, Paterniti  DA, Kelly  K.  Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials.   Cancer. 2014;120(suppl 7):1091-1096. doi:10.1002/cncr.28575PubMedGoogle Scholar
7.
Copur  MS.  Inadequate awareness of and participation in cancer clinical trials in the community oncology setting.   Oncology (Williston Park). 2019;33(2):54-57.PubMedGoogle Scholar
8.
Kennedy-Martin  T, Curtis  S, Faries  D, Robinson  S, Johnston  J.  A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results.   Trials. 2015;16(1):495. doi:10.1186/s13063-015-1023-4PubMedGoogle Scholar
9.
Unger  JM, Cook  E, Tai  E, Bleyer  A.  The role of clinical trial participation in cancer research: barriers, evidence, and strategies.   Am Soc Clin Oncol Educ Book. 2016;35:185-198. doi:10.1200/EDBK_156686PubMedGoogle Scholar
10.
Langford  A, Resnicow  K, An  L.  Clinical trial awareness among racial/ethnic minorities in HINTS 2007: sociodemographic, attitudinal, and knowledge correlates.   J Health Commun. 2010;15(suppl 3):92-101.PubMedGoogle Scholar
11.
Leiter  A, Diefenbach  MA, Doucette  J, Oh  WK, Galsky  MD.  Clinical trial awareness: changes over time and sociodemographic disparities.   Clin Trials. 2015;12(3):215-223. doi:10.1177/1740774515571917PubMedGoogle Scholar
12.
Garza  MA, Quinn  SC, Li  Y,  et al.  The influence of race and ethnicity on becoming a human subject: factors associated with participation in research.   Contemp Clin Trials Commun. 2017;7:57-63. doi:10.1016/j.conctc.2017.05.009PubMedGoogle Scholar
13.
Research America. Clinical trials: survey data of minority populations. Accessed August 25, 2021. https://ictr.johnshopkins.edu/wp-content/uploads/2017/12/Research-America-July-2017.pdf
14.
Research America. Public perception of clinical trials. Accessed August 25, 2021. https://www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf
15.
National Cancer Institute. Health Information National Trends Survey. Accessed November 6, 2020. https://hints.cancer.gov/
16.
Finney Rutten  LJ, Blake  KD, Skolnick  VG, Davis  T, Moser  RP, Hesse  BW.  Data resource profile: the National Cancer Institute’s Health Information National Trends Survey (HINTS).   Int J Epidemiol. 2020;49(1):17-17j. doi:10.1093/ije/dyz083PubMedGoogle Scholar
17.
Clark  LT, Watkins  L, Piña  IL,  et al.  Increasing diversity in clinical trials: overcoming critical barriers.   Curr Probl Cardiol. 2019;44(5):148-172. doi:10.1016/j.cpcardiol.2018.11.002PubMedGoogle Scholar
18.
Chu  SH, Kim  EJ, Jeong  SH, Park  GL.  Factors associated with willingness to participate in clinical trials: a nationwide survey study.   BMC Public Health. 2015;15(1):10. doi:10.1186/s12889-014-1339-0PubMedGoogle Scholar
19.
Anderson  A, Borfitz  D, Getz  K.  Global public attitudes about clinical research and patient experiences with clinical trials.   JAMA Netw Open. 2018;1(6):e182969. doi:10.1001/jamanetworkopen.2018.2969PubMedGoogle Scholar
20.
Willis  GB.  Cognitive Interviewing: A Tool for Improving Questionnaire Design. Sage Publications; 2004.
21.
von Elm  E, Altman  DG, Egger  M, Pocock  SJ, Gøtzsche  PC, Vandenbroucke  JP; STROBE Initiative.  The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.   Ann Intern Med. 2007;147(8):573-577.PubMedGoogle Scholar
22.
Elliott  MN, Zaslavsky  AM, Goldstein  E,  et al.  Effects of survey mode, patient mix, and nonresponse on CAHPS hospital survey scores.   Health Serv Res. 2009;44(2 Pt 1):501-518.PubMedGoogle Scholar
23.
US Department of Agriculture. Rural-Urban Commuting Codes. Accessed August 25, 2021. https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes/
24.
Saitz  R.  Clinical practice: unhealthy alcohol use.   N Engl J Med. 2005;352(6):596-607.PubMedGoogle Scholar
25.
Cohen  J.  A power primer.   Psychol Bull. 1992;112(1):155-159. doi:10.1037/0033-2909.112.1.155PubMedGoogle Scholar
26.
Ludmir  EB, Mainwaring  W, Lin  TA,  et al.  Factors associated with age disparities among cancer clinical trial participants.   JAMA Oncol. 2019;5(12):1769-1773. doi:10.1001/jamaoncol.2019.2055PubMedGoogle Scholar
27.
Unger  JM, Hershman  DL, Albain  KS,  et al.  Patient income level and cancer clinical trial participation.   J Clin Oncol. 2013;31(5):536-542. doi:10.1200/JCO.2012.45.4553PubMedGoogle Scholar
28.
Lind  KD. Excluding older, sicker patients from clinical trials: issues, concerns, and solutions. AARP Public Policy Institute. Accessed August 25, 2021. https://www.aarp.org/content/dam/aarp/research/public_policy_institute/health/2011/i57.pdf
29.
National Cancer Institute. Community Oncology Research Program (NCORP). Accessed December 17, 2020. https://ncorp.cancer.gov/
30.
Wendler  D, Kington  R, Madans  J,  et al.  Are racial and ethnic minorities less willing to participate in health research?   PLoS Med. 2006;3(2):e19. doi:10.1371/journal.pmed.0030019PubMedGoogle Scholar
31.
Langford  AT, Resnicow  K, Dimond  EP,  et al.  Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program.   Cancer. 2014;120(6):877-884. doi:10.1002/cncr.28483PubMedGoogle Scholar
32.
Joseph  G, Dohan  D.  Diversity of participants in clinical trials in an academic medical center: the role of the ‘Good Study Patient?’.   Cancer. 2009;115(3):608-615. doi:10.1002/cncr.24028PubMedGoogle Scholar
33.
Niranjan  SJ, Martin  MY, Fouad  MN,  et al.  Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials.   Cancer. 2020;126(9):1958-1968. doi:10.1002/cncr.32755PubMedGoogle Scholar
34.
NIH Revitalization Act of 1993, S1, 103rd Congress (1993-1994). Accessed August 25, 2021. https://www.congress.gov/bill/103rd-congress/senate-bill/1
35.
St Germain  D, Denicoff  AM, Dimond  EP,  et al.  Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual.   J Oncol Pract. 2014;10(2):e73-e80. doi:10.1200/JOP.2013.001194PubMedGoogle Scholar
36.
Denicoff  AM, McCaskill-Stevens  W, Grubbs  SS,  et al.  The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.   J Oncol Pract. 2013;9(6):267-276. doi:10.1200/JOP.2013.001119PubMedGoogle Scholar
37.
US Food and Drug Administration. Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs: guidance for industry. November 2020. Accessed July 25, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial
38.
Unger  JM, Hershman  DL, Till  C,  et al.  “When offered to participate”: a systematic review and meta-analysis of patient agreement to participate in cancer clinical trials.   J Natl Cancer Inst. 2021;113(3):244-257. doi:10.1093/jnci/djaa155PubMedGoogle Scholar
39.
Saphner  T, Marek  A, Homa  JK, Robinson  L, Glandt  N.  Clinical trial participation assessed by age, sex, race, ethnicity, and socioeconomic status.   Contemp Clin Trials. 2021;103:106315. doi:10.1016/j.cct.2021.106315PubMedGoogle Scholar
40.
Scharff  DP, Mathews  KJ, Jackson  P, Hoffsuemmer  J, Martin  E, Edwards  D.  More than Tuskegee: understanding mistrust about research participation.   J Health Care Poor Underserved. 2010;21(3):879-897. doi:10.1353/hpu.0.0323PubMedGoogle Scholar
41.
Senft  N, Hamel  LM, Manning  MA,  et al.  Willingness to discuss clinical trials among Black vs White men with prostate cancer.   JAMA Oncol. 2020;6(11):1773-1777. doi:10.1001/jamaoncol.2020.3697PubMedGoogle Scholar
42.
Metzl  JM, Hansen  H.  Structural competency: theorizing a new medical engagement with stigma and inequality.   Soc Sci Med. 2014;103:126-133. doi:10.1016/j.socscimed.2013.06.032PubMedGoogle Scholar
43.
Metzl  JM, Maybank  A, De Maio  F.  Responding to the COVID-19 pandemic: the need for a structurally competent health care system.   JAMA. 2020;324(3):231-232. doi:10.1001/jama.2020.9289PubMedGoogle Scholar
44.
Brooks  SE, Muller  CY, Robinson  W,  et al.  Increasing minority enrollment onto clinical trials: practical strategies and challenges emerge from the NRG Oncology Accrual Workshop.   J Oncol Pract. 2015;11(6):486-490. doi:10.1200/JOP.2015.005934PubMedGoogle Scholar
45.
Wilkins  CH, Mapes  BM, Jerome  RN, Villalta-Gil  V, Pulley  JM, Harris  PAJHA.  Understanding what information is valued by research participants, and why.   Health Aff (Millwood). 2019;38(3):399-407. doi:10.1377/hlthaff.2018.05046PubMedGoogle Scholar
46.
Fouad  MN, Acemgil  A, Bae  S,  et al.  Patient navigation as a model to increase participation of African Americans in cancer clinical trials.   J Oncol Pract. 2016;12(6):556-563. doi:10.1200/JOP.2015.008946PubMedGoogle Scholar
47.
Durant  RW, Wenzel  JA, Scarinci  IC,  et al.  Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).   Cancer. 2014;120(suppl 7):1097-1105. doi:10.1002/cncr.28574PubMedGoogle Scholar
48.
Lloyd Wade  J  III, Petrelli  NJ, McCaskill-Stevens  W.  Cooperative group trials in the community setting.   Semin Oncol. 2015;42(5):686-692. doi:10.1053/j.seminoncol.2015.07.011PubMedGoogle Scholar
49.
National Institute on Drug Abuse. Clinical Trials Network (CTN). Accessed March 8, 2021. https://www.drugabuse.gov/about-nida/organization/cctn/clinical-trials-network-ctn
50.
National Institutes of Health Collaboratory. NIH Collaboratory Distributed Research Network (DRN). Accessed March 8, 2021. https://rethinkingclinicaltrials.org/nih-collaboratory-drn/
51.
Hamel  LM, Penner  LA, Albrecht  TL, Heath  E, Gwede  CK, Eggly  S.  Barriers to clinical trial enrollment in racial and ethnic minority patients with cancer.   Cancer Control. 2016;23(4):327-337. doi:10.1177/107327481602300404PubMedGoogle Scholar
52.
Howerton  MW, Gibbons  MC, Baffi  CR,  et al.  Provider roles in the recruitment of underrepresented populations to cancer clinical trials.   Cancer. 2007;109(3):465-476. doi:10.1002/cncr.22436PubMedGoogle Scholar
53.
Brown  R, Bylund  C. Theoretical models of communication skills training. In: Kissane  D, Bultz  B, Butow  P, Finlay  I, eds.  Handbook of Communication in Oncology and Palliative Care. Oxford University Press; 2011:27-40.
54.
Meropol  NJ, Wong  Y-N, Albrecht  T,  et al.  Randomized trial of a web-based intervention to address barriers to clinical trials.   J Clin Oncol. 2016;34(5):469-478. doi:10.1200/JCO.2015.63.2257PubMedGoogle Scholar
55.
Massett  HA, Dilts  DM, Bailey  R,  et al.  Raising public awareness of clinical trials: development of messages for a national health communication campaign.   J Health Commun. 2017;22(5):373-385. doi:10.1080/10810730.2017.1290715PubMedGoogle Scholar
56.
Occa  A, Morgan  SE, Potter  JE.  Underrepresentation of Hispanics and other minorities in clinical trials: recruiters’ perspectives.   J Racial Ethn Health Disparities. 2018;5(2):322-332. doi:10.1007/s40615-017-0373-xPubMedGoogle Scholar
57.
Torres  S, de la Riva  EE, Tom  LS,  et al.  The development of a communication tool to facilitate the cancer trial recruitment process and increase research literacy among underrepresented populations.   J Cancer Educ. 2015;30(4):792-798. doi:10.1007/s13187-015-0818-zPubMedGoogle Scholar
58.
Hoffner  B, Bauer-Wu  S, Hitchcock-Bryan  S, Powell  M, Wolanski  A, Joffe  S.  “Entering a Clinical Trial: Is it Right for You?”: a randomized study of The Clinical Trials Video and its impact on the informed consent process.   Cancer. 2012;118(7):1877-1883. doi:10.1002/cncr.26438PubMedGoogle Scholar
59.
Flory  J, Emanuel  E.  Interventions to improve research participants’ understanding in informed consent for research: a systematic review.   JAMA. 2004;292(13):1593-1601. doi:10.1001/jama.292.13.1593PubMedGoogle Scholar
60.
Nipp  RD, Hong  K, Paskett  ED.  Overcoming barriers to clinical trial enrollment.   Am Soc Clin Oncol Educ Book. 2019;39:105-114. doi:10.1200/EDBK_243729PubMedGoogle Scholar
61.
Nipp  RD, Lee  H, Powell  E,  et al.  Financial burden of cancer clinical trial participation and the impact of a cancer care equity program.   Oncologist. 2016;21(4):467-474. doi:10.1634/theoncologist.2015-0481PubMedGoogle Scholar
62.
Unger  JM, Fleury  ME.  Reimbursing patients for participation in cancer clinical trials.   JAMA Oncol. 2019;5(7):932-934. doi:10.1001/jamaoncol.2019.0141PubMedGoogle Scholar
63.
US Food and Drug Administration. Payments and reimbursements to research subjects—guidance for institutional review boards and clinical investigators. January 2018. Accessed August 26, 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/payment-and-reimbursement-research-subjects
64.
Winkfield  KM, Phillips  JK, Joffe  S, Halpern  MT, Wollins  DS, Moy  B.  Addressing financial barriers to patient participation in clinical trials: ASCO policy statement.   J Clin Oncol. 2018;36(33):3331-3339. doi:10.1200/JCO.18.01132PubMedGoogle Scholar
65.
Cancer Action Network. Barriers to patient enrollment in therapeutic clinical trials for cancer. April 11, 2018. Accessed August 26, 2021. https://www.fightcancer.org/policy-resources/clinical-trial-barriers
66.
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill, 2019, 115th Congress (2018-2019). Accessed September 1, 2021. https://www.congress.gov/115/crpt/hrpt862/CRPT-115hrpt862.pdf
67.
Clinical Treatment Act, HR 913, 116th Congress (2019-2020). Accessed August 26, 2021. https://www.congress.gov/bill/116th-congress/house-bill/913
68.
Bernstein  SL, Feldman  J.  Incentives to participate in clinical trials: practical and ethical considerations.   Am J Emerg Med. 2015;33(9):1197-1200. doi:10.1016/j.ajem.2015.05.020PubMedGoogle Scholar
69.
Maitland  A, Lin  A, Cantor  D,  et al.  A nonresponse bias analysis of the Health Information National Trends Survey (HINTS).   J Health Commun. 2017;22(7):545-553. doi:10.1080/10810730.2017.1324539PubMedGoogle Scholar
×