RIAT

RIAT
Tim Felce (Airwolfhound) · CC BY-SA 2.0 · source
Name	RIAT
Abbreviation	RIAT
Type	Independent investigative initiative
Established	2013
Founders	Ben Goldacre, Peter Doshi, AllTrials
Headquarters	London
Region served	International
Focus	Clinical trial restoration and transparency
Methods	Data reconstruction, scholarly correspondence, open data

RIAT

RIAT is an independent initiative that promotes restoration and transparency of incomplete, misreported, or unpublished clinical trial reports. It advocates for the reconstruction and republication of clinical study reports and trial data to improve the integrity of evidence used in World Health Organization guidance, U.S. Food and Drug Administration reviews, and systematic reviews such as those published in Cochrane Library. The initiative collaborates with academic journals, regulatory bodies, patient groups, and investigative researchers to correct the scientific record and support evidence-based decision-making in contexts involving European Medicines Agency data, National Institutes of Health datasets, and pharmaceutical company submissions.

Definition and scope

RIAT defines a specific corrective pathway for addressing deficiencies in the published clinical trial literature by restoring accurate, complete reports from primary sources such as regulatory submissions, clinical study reports, and trial protocols. Its scope spans interactions with regulatory agencies including the European Medicines Agency and U.S. Food and Drug Administration, academic publishers like The BMJ and PLoS Medicine, and research networks such as AllTrials and Cochrane Collaboration. RIAT’s remit includes reconstructing trials of interventions evaluated in major studies associated with organizations like Pfizer, GlaxoSmithKline, AstraZeneca, Novartis, and trials registered with platforms like ClinicalTrials.gov or regional registries endorsed by World Health Organization standards.

History and origins

RIAT emerged from debates around selective reporting and publication bias highlighted in controversies involving trials like those of Tamiflu (oseltamivir) and the debates surrounding Selective serotonin reuptake inhibitors reporting standards. Prominent figures and groups such as Ben Goldacre, Peter Doshi, AllTrials, and scholars from institutions including University of Oxford and Harvard University advocated for systematic remediation of the literature. High-profile cases that catalyzed attention included concerns tied to reports used in Centers for Disease Control and Prevention guidance and analyses published in journals like The Lancet and The BMJ. The initiative institutionalized practices for restoring trial reports following precedents set in transparency movements involving the European Medicines Agency policy shifts and litigation related to access to clinical study reports in jurisdictions like United Kingdom and European Union courts.

Implementation and methodology

RIAT’s methodology centers on locating primary-source documents—clinical study reports, statistical analysis plans, trial protocols, and regulatory correspondence—then producing a corrected, complete report suitable for publication in peer-reviewed venues. Sources include redacted documents obtained via freedom of information requests to agencies such as the European Medicines Agency and Food and Drug Administration, as well as company submissions from firms like Johnson & Johnson and Bayer. The process involves collaboration with journal editors at outlets including The BMJ, PLoS Medicine, Trials (journal), and scholarly indexing through platforms like PubMed Central. RIAT-authored restorations follow standards employed in systematic reviews by Cochrane Collaboration and meta-analyses published in The Lancet or JAMA to ensure reproducibility and compatibility with established evidence-synthesis methods. Authorship models often resemble those used in multi-centre investigations by groups such as AllTrials and investigative collaborations seen in inquiries like the Mersey Inquiry.

Impact and controversies

RIAT restorations have influenced guideline deliberations in organizations like World Health Organization and National Institute for Health and Care Excellence, and have prompted re-evaluations of drug benefit-risk profiles previously reported by manufacturers including GlaxoSmithKline and Roche. The initiative has been praised by transparency advocates associated with Ben Goldacre and patient organizations advocating for data openness, but it has also faced pushback from some pharmaceutical companies and legal teams citing proprietary concerns and regulatory confidentiality protections invoked by bodies such as the European Medicines Agency and national regulators. Debates mirror earlier disputes over access to trial data in cases involving Tamiflu, conflicts of interest explored in reporting on Vioxx (rofecoxib), and legal precedents set by freedom of information cases in the European Court of Justice.

Notable RIAT initiatives and examples

Notable restorations and related projects include efforts to republish data from influential antiviral and antidepressant trials that shaped guidance in organizations like World Health Organization and Centers for Disease Control and Prevention. Collaborations with journals such as The BMJ led to high-profile corrected reports that fed into systematic reassessments by Cochrane Collaboration reviewers. Projects often targeted trials registered on ClinicalTrials.gov and those submitted to regulators including the European Medicines Agency and U.S. Food and Drug Administration, affecting products from firms like Pfizer, Novartis, and AstraZeneca. RIAT-style restorations have been cited in policy discussions at entities such as National Institutes of Health and in investigative pieces for outlets influenced by reporting on pharmaceutical transparency debates initiated by figures like Ben Goldacre.

Legal and ethical considerations

RIAT operates at the intersection of access-to-information law, publication ethics, and intellectual property regimes. Legal issues include the handling of redacted regulatory documents subject to confidentiality claims by manufacturers including Eli Lilly and Sanofi, and compliance with freedom of information frameworks used with agencies like the European Medicines Agency and Food and Drug Administration. Ethical questions involve authorship attribution consistent with guidance from bodies such as the International Committee of Medical Journal Editors and editorial policies at The BMJ and PLoS Medicine, as well as obligations to trial participants exemplified by principles promoted by World Health Organization declarations. The balance between restoring the record and respecting lawful confidentiality continues to shape RIAT’s collaborations with journals, patient advocates, and regulatory institutions.

Category:Clinical trial transparency