Which pharmaceutical companies use independent intermediaries like YODA or ClinicalStudyDataRequest to govern data access?
Executive summary
Independent intermediaries have become a common route for large drug companies to hand off decisions about who gets patient‑level clinical trial data: Johnson & Johnson has formalized that transfer with the Yale YODA Project and SI‑BONE also lists YODA as a partner [1] [2], while GlaxoSmithKline (GSK) and at least nine other industry sponsors have used the ClinicalStudyDataRequest.com (CSDR) system or related independent review panels to govern access [3] [4].
1. Who uses YODA: Johnson & Johnson, SI‑BONE and a growing roster
The Yale University Open Data Access (YODA) Project was explicitly contracted by Johnson & Johnson in 2014 to serve as an independent intermediary for sharing its pharmaceutical and device trial data, and Johnson & Johnson’s trials constitute the bulk of YODA’s holdings [1] [5]. BioLINCC and YODA listings also identify Johnson & Johnson and SI‑BONE as current YODA data partners, with SI‑BONE providing a small set of iFuse trials through the platform [2]. YODA’s own materials and case studies emphasize that data partners transfer jurisdiction over data‑access decisions to Yale and that the project is supported by grants from participating industry and device companies [6] [7].
2. Who uses ClinicalStudyDataRequest.com: GSK and a coalition of sponsors
ClinicalStudyDataRequest.com (CSDR) emerged from a collaboration led by GSK and became the hub where GSK and “nine additional industry sponsors” engaged an independent panel to review requests, effectively outsourcing gatekeeping for multiple sponsors to a common third‑party mechanism [3] [4]. The platform was developed to enable single‑holder and multi‑holder requests and is widely cited in reviews of open‑access platforms as an early model for pooled independent review [4] [8].
3. Other intermediaries, variants and the Duke/industry model
Not all companies picked the same intermediary: Bristol‑Myers Squibb contracted the Duke Clinical Research Institute (DCRI) to play an independent role in reviewing requests, showing that “intermediary” can mean university projects (YODA), consortium platforms (CSDR) or clinical research institutes (DCRI) depending on the sponsor [3]. Broader platform ecosystems such as Vivli and SOAR also exist and have been used by other sponsors, and papers documenting platform use place YODA, CSDR and Vivli as leading models for industry‑sponsored data sharing [8] [9].
4. Scale, who’s on board and what the evidence does — limits of public reporting
Published audits and cross‑sectional studies confirm that some top pharma companies have public policies and use these intermediaries, but do not provide a neat, exhaustive roster: BMJ and other reviews assessed whether large companies met sharing measures by checking repositories like YODA and CSDR without listing every participating firm by name, and one NCBI policy review notes that multiple large sponsors had transferred review authority to intermediaries while others retained sponsor‑level review [10] [3]. Consequently, while it is verifiable that Johnson & Johnson (YODA), SI‑BONE (YODA), GSK (CSDR) and Bristol‑Myers Squibb (DCRI) are concrete examples, comprehensive enumeration of every company using intermediaries is not available in the provided sources [2] [1] [3] [4] [10].
5. Why companies choose intermediaries — incentives and critiques
Companies transfer review to independent intermediaries to signal impartiality, standardize request evaluation and encourage researcher trust — aims documented in YODA and platform descriptions — but critics and audits flag uneven implementation and limited coverage (many trials remain unavailable) and question long‑term sustainability when industry funding underwrites these intermediaries [7] [5] [11]. Academic analyses and platform primers praise the independent third‑party model as “ideal” for impartial decisions but note that differing review criteria and fragmented platforms still hinder seamless cross‑sponsor meta‑analysis [4] [8].
Conclusion
The evidence in the reporting shows a pragmatic patchwork: Johnson & Johnson (YODA) and SI‑BONE (YODA) are explicit YODA partners, GSK and a group of sponsors launched and used ClinicalStudyDataRequest.com, and Bristol‑Myers Squibb used the DCRI — illustrating a trend among large companies to farm out data‑access governance to external intermediaries, while leaving gaps in public accounting about exactly which other firms do so and the completeness of trial coverage [2] [1] [3] [4] [10].