Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov

Marie Baudart, Philippe Ravaud, Gabriel Baron, Agnes Dechartres, Romana Haneef, Isabelle Boutron

Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68 %) were partially or completely funded by industry. Results for only 189 (39 %, i.e. 65 % of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53 % (n = 158; i.e. 93 % of the total target number of participants) of unpublished studies; 31 % (n = 94) were posted on ClinicalTrials.gov and 21 % (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86 % (114/133) when available in a publication, 91 % (62/68) when available on ClinicalTrials.gov, and 80 % (33/41) when available on the sponsor website. Only 39 % of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov had their results published at least 30 months after study completion. The registration of these observational studies allowed searching other sources (results posted at ClinicalTrials.gov and sponsor website) and obtaining results for half of unpublished studies and 93 % of the total target number of participants.