Authors' reports about research integrity problems in clinical trials☆
Section snippets
Sample
We gathered a sample of authors from The Cochrane Database of Systematic Reviews, an online collection of meta-analytic reviews published by the Cochrane Collaboration [16], a coalition of clinical researchers who conduct research reviews according to a common set of methods. The reviews summarize all known reports on the effectiveness of a given drug or treatment. We had two reasons for gathering articles from Cochrane. First, the Cochrane reviewers saved us time because they had already
Results
Of the 549 authors mailed surveys, 45 surveys were returned with bad addresses, so we counted 504 surveys as having reached authors. We received 322 completed surveys, so our return rate was 59% of 549 authors, or 64% of 504 authors net of those not reached because of bad addresses.
Table 1 describes the authors who returned surveys. Most were MDs and identified themselves as “organizing PI” or “site PI.” The large proportion of authors who described themselves as “organizing PI” suggests that
Discussion
This study presents authors' reports of research integrity problems in three contexts. First, we found that 0.6% of authors reported that the article misrepresented the research it published. Although the confidence interval around this rate includes the rate reported by Weiss et al. [10], the results are difficult to compare, for two reasons. First, Weiss's methods detected only falsification, whereas our survey asked about falsification and misrepresentation. Second, Weiss's methods would
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Grant support: the research was supported by the Office of Research Integrity Research Program on Research Integrity (R01 NS42449, PI: Gardner).