Healthy Skepticism Library item: 6973

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Publication type: Journal Article

Djulbegovic B, Bennett CL, Adams JR, Lyman GH.
Authors' reply
The Lancet 2000 Dec 23; 356:(9248):2193

Abstract:

Halpern and Karlawish contend that no relation exists between ethical and scientific principles of RCTs and outcomes. We disagree. It is reasonable to assume some relation between equipoise and outcomes. There are three possible relations: on average, innovative treatments are better, standard treatments are better, or there is no difference. We postulate that the third is most likely. We have not focused on equipoise for individual trials, but on a group of trials over time. If the uncertainty principle applies, the distribution of belief probabilities should average out around 50/50 between preference for standard and innovative therapies. If not, patients should be cautious about entering into trials. By preserving the uncertainty principle we are preserving the system of clinical trials in medicine! This is the main reason we called for improvement in empirical assessment of this principle. Our study is only the first step. Halpern and Karlawish state that much of the difference between private and public trials might be attributable to differential use of inferior controls and that we must stratify our analysis by control type. We agree. That it is what violation of the uncertainty principle means and what we discussed. We agree with Nuesch and Dieterle that there are many sources for bias. However, sponsorship bias has been acknowledged by the World Medical Association Declaration Of Helsinki’s Ethical Principles for Medical Research Involving Human Subjects. This states that full information about funding, sponsors, institutional affiliations, and other potential conflicts of interest and incentives must be disclosed.

Keywords:
*letter to the editor/United States/clinical trials/statistical significance/uncertainty principle/bias/relationship between medical profession and industry/conflict-of-interest/declaration of interests/ETHICAL ISSUES IN PROMOTION: ETHICS OF TRIALS/ETHICAL ISSUES IN PROMOTION: PAYMENTS IN STUDIES/SPONSORSHIP: RESEARCH