Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis

Abstract

ObjectivesTo 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.DesignCross-sectional descriptive analysis.Setting and participantsNovel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.Main outcome measuresUsing 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 multicomponent 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.Results26% 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.ConclusionsIt 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 maximise the benefits of research for patient care and scientific innovation.

Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration

“…In our study, only 32% of evaluated pharmaceutical companies outside the top 20 by global revenue had a publicly accessible data sharing policy, which is in stark contrast to 100% of sponsors within the top 20 by global revenue. These findings are in line with previous research and demonstrate a continued need for advocacy and support for smaller pharmaceutical companies to enable data transparency. Despite their lower revenue, these smaller companies anchor the registration of a substantial portion of critical innovator medicines in oncology.…”

A ‘patient–industry complex’? Investigating the financial dependency of UK patient organisations on drug company funding

“…However, rejecting the patient–industry complex position is unwarranted as it has never specified a necessary share of financially dependent organisations. Moreover, as we have mentioned, the possibility of under‐reporting of financial links remains and cannot be discounted, especially in view of ongoing concerns that clinical trials are massively underreported in the pharmaceutical sector, although larger companies are typically more compliant with reporting requirements (Axson et al, 2021; Goldacre et al, 2018). That said, our data suggest that likely pockets of a patient–industry complex exist in the subsection of organisations highly reliant on industry funding.…”

Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study

“…The objective of this paper, to develop measures of fair inclusion in clinical research, was identified and developed during a roundtable that JM organized in 2017 with patients and patient advocacy groups (participant list was previously published). 21 A patient advocacy organization (Susan G Komen Foundation) then sponsored this study and is an acknowledged contributor. In June 2022, we held a 7 hour roundtable with approximately 40 individuals representing research sponsors (online supplemental box 2) on these measures, with majority if not unanimous agreement on their reasonableness and appropriateness.…”