AllTrials campaign

AllTrials campaign
Name	AllTrials campaign
Formation	2013
Type	Advocacy coalition
Headquarters	United Kingdom
Founders	Ben Goldacre, Tamiflu whistleblowers, Sense about Science
Purpose	Clinical trial transparency, research reporting

AllTrials campaign The AllTrials campaign is an advocacy coalition launched in 2013 calling for the registration and reporting of the results of all clinical trials. It arose from concerns raised by researchers, clinicians, patients, and journalists about unpublished trial data and selective reporting, advocating for systematic transparency across pharmaceutical, academic, and regulatory domains.

Background and objectives

AllTrials emerged after high-profile disputes involving antiviral studies and antidepressant trials, when figures including Ben Goldacre, activists from Sense about Science, and whistleblowers associated with trials of oseltamivir advocated for comprehensive trial disclosure. The campaign’s objectives included mandatory prospective registration on repositories such as ClinicalTrials.gov and ISRCTN Registry, full reporting of results to regulators like the European Medicines Agency, and retrospective release of anonymized individual patient data from sponsors including GlaxoSmithKline, Roche, and Pfizer. The movement aligned with earlier initiatives such as the CONSORT Statement and calls by bodies like the World Health Organization and the Cochrane Collaboration for research transparency.

Campaign activities and methods

AllTrials employed petitions, public letters, media engagement, and policy advocacy to press institutions including the European Commission, the United States Food and Drug Administration, and the National Health Service for reforms. The coalition worked with patient groups such as Sense about Science partners, academic centres including University College London and Queen Mary University of London, and investigative outlets like BMJ and The Guardian to publicize cases of selective reporting. Methods included data requests to regulators such as EMA, litigation allied with organizations like Transparency International style advocates, and collaboration with open-data platforms exemplified by OpenTrials and repositories modeled on Figshare.

Supporters, signatories, and opposition

The campaign secured endorsements and signatures from thousands of clinicians, researchers, and patient organizations, including entities like Cochrane Collaboration, British Medical Journal, and professional societies such as the Royal College of Physicians. Prominent signatories included academics from Harvard University, University of Oxford, and University of Cambridge, and activists connected to Sense about Science. Opposition or reticence came from some pharmaceutical firms and trade associations like PhRMA and national regulators wary of unredacted data release, and certain legal advisers referencing intellectual property protections and contractual confidentiality with companies such as Novartis and Sanofi.

Impact on policy, regulation, and research practice

AllTrials influenced regulatory disclosures and policy debates, contributing to shifts at the European Medicines Agency which moved toward greater access to clinical study reports, and to reform of registration practices at ClinicalTrials.gov. Its advocacy intersected with legislative action in jurisdictions where lawmakers in bodies such as the European Parliament and the United States Congress debated trial-reporting mandates. Academic publishing standards evolved with journals like The BMJ and publishers such as Wiley-Blackwell and Elsevier strengthening requirements for trial registration consistent with recommendations from groups like ICMJE. Funders including Wellcome Trust and Medical Research Council (United Kingdom) adopted data-sharing expectations, while initiatives such as the YODA Project advanced controlled access to anonymized participant-level datasets.

Criticisms and controversies

Critics argued that blanket data release risks breaching participant confidentiality, undermining commercial confidentiality, and enabling data misinterpretation by entities including some media outlets or litigants. Concerns were raised by legal advisers linked to PhRMA and representatives from companies like AstraZeneca about redaction burdens and proprietary information. Debates engaged ethicists from institutions such as Nuffield Council on Bioethics and lawyers associated with European Court of Human Rights precedents, and disputes arose over retrospective demands for data from long-completed trials overseen by sponsors like Eli Lilly.

Notable outcomes and case studies

Notable outcomes include increased transparency around influenza antivirals after scrutiny over the oseltamivir evidence base, legislative and regulatory commitments by the European Medicines Agency to release clinical study reports, and high-profile data releases negotiated via projects such as Yale Open Data Access Project (YODA) and Clinical Study Data Request. Case studies include retrospective re-evaluations of antidepressant trials linked to researchers at institutions including King's College London and systematic reviews by Cochrane that revised effect estimates after incorporation of previously unpublished data. The campaign also catalysed development of infrastructures like OpenTrials to aggregate trial metadata and foster reproducible meta-analyses conducted by teams from University of Bristol and London School of Hygiene & Tropical Medicine.

Category:Health advocacy