Transparency in the release of human subjects trials results in the public domain among studies registered on clinicaltrials.gov
Tuesday, November 5, 2013
The information on clinical trials should be accessed by the public to maintain transparency. ClinicalTrials.gov (CTG) is a national web-based resource where clinical trials are registered and some of them are required to submit the results under the Food and Drug Administration Amendments Act of 2007. In this study, the CTG data set of registered trials was analyzed to identify predictors of transparency vs. non-transparency. We defined transparency' as either posting results on CTG or publishing the main effects article, and non-transparency' as neither posting results on CTG nor publishing the main effects article. We conducted univariate, bivariate and logistic regression analyses. Among 1499 eligible interventional clinical trials registered on CTG and reported as completed in 2008 in CTG, 400 clinical trials were randomly selected. 118 clinical trials (29.5%) lacked transparency. Phase 2 clinical trials were more likely to be non-transparent than phase 3/4 clinical trials (adjusted OR 1.56; 95%CI 0.93 - 2.57, p=0.09); clinical trials run by industry-only were more likely to be non-transparent than clinical trials run by others (adjusted OR 1.7; 95%CI 0.92 3.18, p=0.09); and randomized control trials were more likely to be non-transparent than non-randomized clinical trials (adjusted OR 2.42; 95%CI 1.31 4.46, p=0.005). In conclusion, lack of transparency is common-place among trials registered on CTG, even with four years of time in which to release results into the public domain. Lack of transparency is more common among industry sponsored trials and those at earlier stages of clinical development.
Conduct evaluation related to programs, research, and other areas of practice
Public health or related research
Identify predictors to determine studies that are neither published in peer review journals nor result-posted in ClinicalTrials.gov.
Describe the outcome and time course of clinical trials registered in ClinicalTrials.gov
Keyword(s): Research, Health Information
Presenting author's disclosure statement:
Qualified on the content I am responsible for because: I have been working on data analysis of ClinicalTrials.gov, a publicly accessible website since I graduated from Boston University School of Public Health where I met Chris Gill, who had already been working on this issue. Among my scientific interests are publication bias and transparency of clinical trials.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines,
and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed
in my presentation.