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March 15, 2000

Sources of Bias in the Economic Analysis of New Drugs

Author Affiliations

Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Fishbein FellowIndividualAuthor

JAMA. 2000;283(11):1423-1424. doi:10.1001/jama.283.11.1421

To the Editor: Mr Friedberg and colleagues1 take a systematic approach to identifying the characteristics of published cost studies. However, relying on study sponsorship as the dominant criterion for evaluating potential conflict of interest may be too simplistic. A more thorough review of methods, data inputs, assumptions, and publication sources and their impact on study conclusions is warranted. For example, prospective, randomized clinical studies (single center or multicenter) using actual use and cost data may be less biased than studies developed using decision analysis models. Additionally, some of the studies included in the analysis were not published in peer-reviewed journals. To combine heterogeneous samples in drawing conclusions is improper both in clinical research and the evaluation of conflict of interest.

Furthermore, in more than 10% of cases in which authors were contacted regarding potential conflicts, authors and/or publishers failed to report industry relationships. Therefore, it can be difficult for readers to fully understand potential sources of conflict of interest unless disclosure and reporting policies are standardized and enforced.

In evaluating the potential for biases, it may be more prudent for readers to evaluate clinical and economic literature across several criteria including sponsorship, author affiliation, journal type, study methods and assumptions and the extent to which authors' conclusions and statements are supported by the data presented. Rather than focusing solely on pharmaceutical industry sponsorship, perhaps the best advice should be caveat lector (let the reader beware).

Friedberg  MSaffran  BStinson  TJNelson  WBennett  CL Evaluation of conflict of interest in economic analyses of new drugs used in oncology.  JAMA. 1999;282:1453-1457.Google Scholar