Sharing of de-identified patient level data from human clinical trials: analysis of US-based studies in the ClinicalTrials.gov registry

Authors

• V Huser

Abstract

Sharing of de-identified participant level data from human clinical trials is increasing and often mandated by sponsors. However, because of increasing number of data sharing platforms, such as ProjectDataSphere or ClinicalStudyDataRequest, it can be difficult to judge each platform’s relative importance. In US, separate legal mandate requires trial sponsors to register their applicable studies in the ClinicalTrials.gov (CTG) registry. CTG allows study record managers to optionally specify individual participant data (IPD) sharing plan. To investigate how trial data is being shared, we analyzed sharing plan descriptions of US-based studies in CTG (which platform, format and access restrictions). As of April 2017, CTG registry contained 244,752 study registrations and 26,028 study results. 102,005 studies had at least one US site (US studies). 6,248 studies answered “Yes” to sharing IPD data (of which 2,293 were US studies). To reduce the amount of manual review, we analyzed several smaller subsets. To illustrate results (poster will include all subsets), subset B included studies with IPD sharing description that repeated at 3 times (668 studies). In subset B, 72.8% (486 studies) indicated ClinicalStudyDataRequest.com as the sharing platform. When analyzed by study start year, number of IPD sharing studies is increasing rapidly (counts: 155 [2014]; 233 [2015]; 723 [2016]). In conclusion, CTG’s data sharing study metadata offers limited insights into data sharing trends. CTG’s increased curation of entered data could eliminate vague sharing descriptions (such as ‘publication’, ‘the data will be transferred to at the end of the study’, or ‘as requested’).

Scientific Focus Area: Research Support Services

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