Mainstream drugs for which raw patient datasets have not been released

1. What the evidence actually says about withheld patient‑level data

A decade of audits and policy reviews finds that pharmaceutical firms and regulators remain selective about releasing raw trial data: regulators like the European Medicines Agency began releasing clinical study reports (CSRs) only after pressure, yet IPD sharing commitments remain partial, and recent literature estimates that about 50% of participant‑level data supporting newly registered medicines are not eligible for request under industry policies and procedures ^{[2] [1]}.

2. Why many mainstream datasets remain off limits — concrete, documented reasons

The literature identifies several documented reasons that prevent IPD release: ongoing patient follow‑up or extended embargo periods, the need for dual approvals from agencies such as the EMA and FDA, and the absence of explicit informed consent for wider data sharing — all cited as legitimate exclusions in company and policy reviews ^[1]. In short, procedural and consent constraints are repeatedly given in the sources as the proximate causes for datasets being excluded from sharing ^[1].

3. Privacy, law and corporate practice that complicate transparency

Privacy protections and commercial data governance are central to why companies hold back: reporting on regulatory frameworks emphasizes HIPAA and consent protocols as core protections around personal health information, and commentators warn that evolving national and state privacy laws and industry data‑residency rules create a compliance maze that makes broad public release of patient‑level data legally fraught ^{[3] [4] [5]}.

4. Empirical audits show the problem exists across high‑profile therapeutic areas

Targeted audits reinforce that the lack of sharing is not hypothetical: quality assessments of anticancer drug approvals and broader audits of company transparency policies document uneven practices and gaps in IPD availability for medicines that enter major markets, indicating this is a cross‑cutting industry phenomenon rather than confined to obscure compounds ^{[6] [2]}.

5. What can and has been released — and why that matters for verification

Regulatory documents such as clinical study reports are large, detailed files used by regulators and sometimes released on request; researchers note CSRs can contain substantially more information on benefits and harms than academic articles and were made available by the EMA after an ombudsman finding of maladministration, demonstrating that regulatory levers can force greater access even when IPD remains restricted ^[2].

6. Why a pill‑by‑pill list cannot be compiled from the provided reporting

The available sources establish patterns and causes but do not enumerate individual mainstream drugs for which raw patient datasets were withheld; the systematic reviews and audits cited intentionally report percentages, policy gaps, and case‑area audits rather than producing a running list of specific branded or generic drugs whose IPD is unavailable — therefore a definitive catalog of “mainstream drugs” lacking released raw datasets cannot be produced from these documents alone ^{[1] [6] [2]}.

7. Practical implications and next steps for verification

The reporting implies that verification of whether a given mainstream drug’s raw trial datasets were released requires checking regulatory archives and company data‑sharing portals or audit reports focused on that drug or approval cohort; the sources demonstrate both the value of CSRs and the recurring problem that roughly half of participant‑level datasets for newly registered medicines fall outside current sharing mechanisms, which should guide demands for targeted audits and regulatory reform ^{[2] [1] [6]}.