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Original Investigation
May 17, 2018

Characteristics of Radiotherapy Trials Compared With Other Oncological Clinical Trials in the Past 10 Years

Author Affiliations
  • 1Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, Guangdong, China
  • 2Department of Radiation Oncology, Stanford University, Stanford, California
  • 3Division of Radiation Oncology, National Cancer Centre Singapore, Singapore
  • 4Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York
  • 5Department of Radiation Oncology, University of Toronto, Princess Margaret Cancer Center, Toronto, Ontario, Canada
  • 6Department of Clinical Oncology, The University of Hong Kong and The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, China
JAMA Oncol. Published online May 17, 2018. doi:10.1001/jamaoncol.2018.0887
Key Points

Question  How does a climate of expanding targeted and immune therapies but declining funding from the National Institutes of Health affect the conduct of radiotherapy trials compared with other oncological trials?

Findings  In a cross-sectional analysis of 25 907 interventional oncological trials registered in ClinicalTrials.gov from 2007 to 2017, only 1378 (5.3%) were radiotherapy trials. Sponsorship or funding for radiotherapy trials was significantly less than that for other oncological studies, and the proportion of radiotherapy trials with a sample size of more than 100 patients has decreased in the past decade.

Meaning  The decline of radiotherapy trials warrants discussion and collaboration among oncologists, funding agencies, industry leaders, and other concerned parties across multiple geographic regions.

Abstract

Importance  Modern precision radiotherapy is an innovative and effective treatment of cancer, yet it is unclear how radiotherapy trials are affected by expanding targeted and immune therapies and declining National Institutes of Health funding.

Objective  To analyze and compare the characteristics of radiotherapy trials with other oncological trials registered on ClinicalTrials.gov.

Design, Setting, and Participants  This is a cross-sectional analysis of trials registered on ClinicalTrials.gov between June 1, 2007, and May 8, 2017. Records of all 243 758 clinical studies registered by May 8, 2017, were downloaded, but only 25 907 interventional oncological trials registered between June 1, 2007, and May 8, 2017, and whose primary purpose was “treatment” were included in the final analysis. Trials were categorized according to cancer type and other registration information.

Main Outcomes and Measures  Characteristics of radiotherapy trials were compared with characteristics of other oncological trials. Chronological shifts in radiotherapy trials were also analyzed.

Results  Of the 25 907 trials selected, 1378 (5.3%) were radiotherapy trials and 24 529 (94.7%) were other oncological studies. The number of radiotherapy trials increased gradually from 94 (June 1, 2007, through May 31, 2008) to 192 (June 1, 2015, through May 31, 2016). Radiotherapy trials were less likely than other oncological studies to be registered before participant enrollment (763 of 1370 [55.7%] vs 16 105 of 24 434 [65.9%]; P < .001), to be blinded (45 of 1378 [3.3%] vs 2784 of 24 529 [11.3%]; P < .001), or to involve multiple geographic regions (2.4% vs 9.5%; P < .001), but they were more likely to be phase 2 to 3 (773 of 1124 [68.8%] vs 12 910 of 22 300 [57.9%]; P < .001) and to have a data-monitoring committee (839 of 1264 [66.4%] vs 11 728 of 21 060 [55.7%]; P < .001). Only a minority of radiotherapy trials were industry sponsored, which was significantly lower than for other oncological trials (80 of 1378 [5.8%] vs 10 651 of 24 529 [43.4%]; P < .001; adjusted odds ratio, 0.08; 95% CI, 0.06-0.10). The number of National Institutes of Health–sponsored radiotherapy trials decreased from 80 of 544 trials (14.7%) from 2007 to 2012 to 72 of 834 trials (8.6%) from 2012 to 2017 (P < .001). Radiotherapy trials with a sample size of more than 100 patients decreased from 155 of 543 trials (28.5%) from 2007 to 2012 to 157 of 833 trials (18.8%) from 2012 to 2017 (P < .001).

Conclusions and Relevance  The limited number of and the scarcity of funding for radiotherapy trials is concerning given the integral role of radiotherapy in the clinical management of patients with cancer worldwide. A multidisciplinary collaboration to promote and fund more radiotherapy research is warranted.

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