List pharmaceutical companies which allow independent reanalysis of participant‑level data
Executive summary
A substantial subset of large pharmaceutical firms have formal policies or platforms that permit independent reanalysis of de‑identified participant‑level data (PLD), but access is heterogeneous, conditional, and often mediated through third‑party intermediaries rather than open public posting [1] [2]. Landmark examples include GlaxoSmithKline’s ClinicalStudyDataRequest system and sponsors that delegate review to independent intermediaries such as Johnson & Johnson’s transfer to the Yale‑run YODA project or Bristol‑Myers Squibb’s use of an external reviewer, though audits show many policies do not translate into routine availability for specific trials [3] [4] [5].
1. Which companies explicitly enable independent reanalysis — named examples and mechanisms
GlaxoSmithKline (GSK) has long operated the ClinicalStudyDataRequest platform established in 2013 to share participant‑level datasets with independent researchers, and multiple other sponsors contributed studies through that portal [3]. Johnson & Johnson has formally transferred authority for reviewing PLD requests to the Yale Open Data Access (YODA) project, creating an independent adjudication pathway for researchers seeking trial data [4]. Bristol‑Myers Squibb has contracted external reviewers (Duke Clinical Research Institute) to manage requests, illustrating the model in which sponsors outsource governance of access [4]. These named arrangements show that several industry leaders have operational routes for independent reanalysis rather than purely internal gatekeeping [3] [4].
2. How widespread are these policies — headline statistics and their limits
Assessments find a majority of large sponsors now publish IPD‑sharing policies, with a 42‑company audit reporting roughly three‑quarters (74%) had a stated policy, and later evaluations of high‑revenue medicines finding 64% of supporting trials were eligible for IPD requests; yet other audits show far fewer trials are practically shareable—only 15% of a sampled set were confirmed eligible two years after publication—demonstrating a gap between policy and practice [6] [1] [5]. Good Pharma Scorecard analyses also reported only 25% of large companies fully met a composite data‑sharing measure, underlining major heterogeneity across firms [2].
3. The controlled‑access model: third‑party review, redaction, and conditionality
Most companies avoid open public posting of PLD due to re‑identification risks and instead use controlled‑access models that require independent scientific review panels, data use agreements, and redaction/anonymization steps; the literature recommends independent panels and training to assess requests while companies limit themselves to eligibility determinations [7] [8]. This model enables independent reanalysis in principle but imposes procedural barriers—varying review criteria, redaction heterogeneity, and sponsor‑set eligibility rules—that affect whether a given researcher can obtain analysis‑ready datasets [9] [8].
4. What audits and reanalyses reveal — progress and persistent obstacles
Independent audits and quality‑improvement studies find meaningful but uneven progress: some high‑profile medicines now have multiple trials eligible for requests, yet many datasets remain unavailable, heavily redacted, or managed internally in ways that impede replication and pooled meta‑analysis [1] [10]. Investigations note few published independent reanalyses overall, suggesting that even with policies in place, practical obstacles—platform fragmentation, slow adjudication, and inconsistent metadata—limit reuse [3] [7].
5. Competing narratives, incentives, and what the evidence does not settle
Industry emphasizes patient privacy and the logistical burden of preparing PLD while transparency advocates push for open access models to enable immediate verification; both positions are visible across the reviewed literature and audits, which also flag potential conflicts when sponsors retain some control over eligibility criteria or platform choice [8] [4]. The sources document which companies and mechanisms exist and quantify variability, but they do not provide a comprehensive, current roster of every firm that will grant reanalysis for every trial—reporting focuses on samples, platforms, and audits rather than a definitive company‑by‑company checklist [2] [6].