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In this issue (page 477) Bhandari and colleagues1report an association between industry funding of clinical trials and findings of statistical significance. The authors extend previous studies of drug trials2-7 by including surgical and nonsurgical, nondrug trials and suggest that industry funding has a significant influence on the results of both surgical and drug trials. To many readers, the findings may seem self-evident. Hardly a week passes without an article, commentary or editorial in a prominent medical journal raising concerns about conflicts of interest, particularly financial, and concluding that research sponsored by industry is "biased." I do not believe that use of the term "industry" is any more appropriate than "all physicians" when discussing standards of medical practice. Pharmaceutical companies differ in their approaches to clinical trials and their publication; here I speak from the perspective of Merck & Co., Inc. (Merck-Frosst in Canada; MSD outside North America).
Several studies have shown associations between the funding of clinical trials by for-profit organizations and the reporting of positive results2-6 or conclusions;8,9 others have not.7,10 Broadly, explanations offered for this include the following: companies fund only studies that will demonstrate positive outcomes for their product(s); studies are designed or conducted poorly (including inappropriate comparators); and negative or unfavourable studies are not published.4 I will address each of these issues in turn.
First, during the product development and registration process, pharmaceutical companies often need to conduct some placebo-controlled trials as a requirement for regulatory approval; these are more likely than other types of trials (e.g., active comparators) to be "positive." Furthermore, since companies can undertake only a finite number of studies concerning a product's safety or efficacy profile, studies thought more likely to succeed receive higher priority. This is not unlike the situation of researchers in academia and government, who have views that influence the research questions they ask and the studies they conduct. Perhaps, based on their experience with preclinical and early-phase clinical studies of a candidate product, companies are able to select trials in later stages of development with a higher likelihood of positive return, but researchers in all of these domains simply cannot predict the results of all trials in advance.5,11-14
Second, numerous studies have shown that the operational quality of trials sponsored by pharmaceutical companies...