Clinical Trial Transparency and Data-Sharing Among Bio-Pharmaceutical Companies and the Role of Company Size, Location, and Product Type: A Cross-Sectional Descriptive Analysis

Objective: To examine company characteristics associated with better
transparency and to apply a tool used to measure and improve clinical
trial transparency among large companies and drugs, to smaller companies
and biologics. Design: Cross-sectional descriptive analysis. Setting and
participants. Novel drugs and biologics FDA approved in 2016 and 2017, and
their company sponsors. Using established Good Pharma Scorecard (GPS)
measures, companies and products were evaluated on their clinical trial
registration, results dissemination, and FDA Amendments Act (FDAAA)
implementation; Companies were ranked using these measures and a
multi-component data sharing measure. Associations between company
transparency scores with company size (large vs non-large), location (US
vs non-US), and sponsored product type (drug vs biologic) were also
examined. 26% of products (16/62) had publicly available results for all
clinical trials supporting their FDA approval and 67% (39/58) had public
results for trials in patients by 6 months after their FDA approval; 58%
(32/55) were FDAAA compliant. Large companies were significantly more
transparent than non-large companies (overall median transparency score of
95% [IQR 91-100] vs 59% [IQR 41-70], p<0.001), attributable to
higher FDAAA compliance (median of 100% [IQR 88-100] vs 57% [0-100],
p=0.01) and better data sharing (median of 100% [IQR 80-100] vs 20% [IQR
20-40], p<0.01). No significant differences were observed by
company location or product type. It was feasible to apply the GPS
transparency measures and ranking tool to non-large companies and
biologics. Large companies are significantly more transparent than
non-large companies, driven by better data sharing procedures and
implementation of FDAAA trial reporting requirements. Greater research
transparency is needed, particularly among non-large companies, to
maximize the benefits of research for patient care and scientific
innovation.