Which statin clinical trials have made patient‑level data available through controlled access platforms?
Executive summary
Clinical‑level patient data from many randomized statin trials have been shared with researchers through controlled‑access channels, but public reporting rarely lists trial names; an influential harmonisation project received patient‑level adverse‑event datasets from 23 double‑blind and 5 open‑label statin trials via direct transfer or online platforms [1]. Platforms that mediate access include ClinicalStudyDataRequest.com (CSDR) and the Yale Open Data Access (YODA) project, and pharmaceutical sponsors such as Novartis, Daiichi Sankyo and Janssen/Johnson & Johnson have participated in those systems [2] [3] [4] [5].
1. What the reporting actually shows about which trials are available
Available evidence shows that numerous large statin trials contributed individual‑participant adverse‑event data to a harmonisation/meta‑analysis effort: data from 23 double‑blind and 5 open‑label statin trials were provided either by direct transfer or through online access platforms, but the public article that describes that harmonisation does not enumerate every trial name in the excerpts provided here [1]. Independent reviewers and campaigners (notably The BMJ and researchers seeking clinical study reports) have identified dozens of statin trials of interest—The BMJ tracked 34 trials in its open‑data campaign—but the BMJ coverage documents the demand for anonymised IPD rather than a definitive catalogue of which trials are accessible on which platforms [6] [5].
2. Which controlled‑access platforms are involved
The principal controlled‑access platforms named in the sources are ClinicalStudyDataRequest.com (a consortium platform hosting multiple sponsors’ trial data) and the Yale Open Data Access (YODA) project, which receives and mediates access to Janssen/J&J data; institutional guides also point investigators to controlled‑access repositories for anonymised patient‑level datasets [4] [5] [7]. The harmonisation work that pooled adverse‑event IPD cites both direct transfers and “online access platforms” as the means by which trial data were shared, implying use of these controlled systems [1].
3. Which sponsors of statin trials have policies and deposits to share IPD
Corporate sponsors documented as participating in multi‑sponsor sharing platforms include GlaxoSmithKline, Novartis and Daiichi Sankyo among others listed on platform rosters, and Janssen/J&J has explicitly committed to deposit anonymised pharmaceutical trial data with YODA [2] [3] [5]. The 2017 review of open‑access platforms enumerates a broad set of pharma sponsors who deposit trials to CSDR and similar services, underscoring that sponsor policy—date ranges, approval status and publication—governs what gets shared [2].
4. What can and cannot be asserted from the reporting
The reporting allows authoritative statements that patient‑level data for many statin RCTs were pooled for meta‑analysis and that multiple controlled‑access platforms and pharma sponsors facilitate requests; the reporting does not permit a definitive public list of every statin trial by name that is currently accessible via each platform from the excerpts provided here, and therefore no claim is made beyond what the sources document [1] [2] [4]. Campaigners’ demands for full anonymised IPD from trials (The BMJ) and investigators’ mixed experiences accessing clinical study reports show an ongoing gap between aspiration and complete, easily searchable transparency [6] [3].
5. Privacy, governance and how access typically works
Controlled‑access sharing is presented as a privacy‑aware, negotiated process: shared datasets are de‑identified and accessed under legally binding data‑sharing agreements that prohibit re‑identification and onward distribution, and the literature stresses balancing data utility against privacy risk [8]. Platforms typically require a research proposal and administrative review to confirm availability and appropriate protections before granting access—steps that shape what researchers can actually obtain [2].
6. Practical next step for anyone seeking specific trial datasets
To identify which named statin trials have downloadable or remotely accessible IPD, the only reliable path—based on the sources—is to search platform catalogs and sponsor pages (ClinicalStudyDataRequest.com, YODA) and to query the trial lists used by harmonisation collaborations such as the Cholesterol Treatment Trialists’ group, because public summaries in the sources confirm availability in aggregate but do not publish a complete trial‑by‑trial inventory in the provided excerpts [4] [1] [5]. Researchers should also anticipate application reviews, data use agreements, and variable sponsor policies determining what is released and when [2] [8].