Clinical Trials Transparency: Problems, Solutions, Policy Asks
This presentation explains the problem of unreported and misreported clinical trials and its huge impact on patients, public health systems and medical research worldwide.
It discusses progress made to date, and outlines concrete policy solutions for governments, trial funders, and clinical trial sponsors. Other health groups are welcome to re-use these slides.
This study provides a comprehensive and accessible overview of the current state of clinical trial transparency for policy makers. It documents how regulatory failings and weak institutional compliance harm patients, undermine decision-making by public health agencies, lead to the waste of health funds, slow medical progress, and expose shareholders to substantial risks. The study sets out concrete legal, regulatory and administrative measures that policy makers should take to strengthen the five pillars of trial transparency: trial registration, summary results posting, full trial reports, academic publication, and individual patient data.
This report documents at least 445 drug trials left partially or completely unreported by university medical centers across Germany .
The report shows that German universities are lagging far behind their peers in other countries in clinical trial reporting. It was widely covered in the national media and led the German Medical Association and IQWIG to urge universities to improve their performance. The report contains practical guidance for universities and German regulators on how to tackle the problem.
Published by TranspariMED and BUKO-Pharmakampagne on 30 December 2019.
This report documents widespread violations of EU transparency rules by Europe's 30 top medical research universities
It finds that at least 778 university-run clinical trials are missing results on the European registry EUCTR, and that national regulators across the continent are failing to keep registry records up to date. While three universities perform strongly, 14 have yet to post a single trial result. The report contains practical guidance for universities and regulators on how to tackle the problem.
Published by TranspariMED and three European partners on 30 April 2019.
This report provides an estimate of research waste within the clinical trial portfolios of NHS Trusts in Britain.
Based on data drawn from the European trial registry and information supplied by the 14 NHS Trusts sponsoring the largest number of clinical trials, this report arrives at an estimate of 500 completely unreported 500 clinical trials, representing an investment of £250 million, across all NHS Trusts in the UK.
The report documents large differences in Trusts' oversight over their trial portfolios, and in their approaches to disclosing funding data.
Published by TranspariMED on 21 October 2019.
This report documents the remarkable progress UK universities are making in preventing research waste and retrospectively posting clinical trial results.
Based on responses to Freedom of Information requests by 25 UK universities, the report provides a snapshot of a sector that is rapidly embracing global best practices. Most UK universities are putting into place strong policies and processes to ensure that every clinical trial is registered and posts its summary results onto trial registries within 12 months. In addition, most universities are auditing - or planning to audit - their past trial portfolios to identify trials that have remained completely unreported, and taking steps to retrospectively make the results public.
Published by TranspariMED on 20 June 2019.
This report examines to what extent 40 major US universities comply with legal requirements to make clinical trial results public.
It finds that 25 out of 40 universities are in breach of the law. In total, 140 out of 450 clinical trials subject to the FDA Amendments Act that were sponsored by these universities are missing results. On the positive side, 15 universities have reported the results of all applicable trials. [Note on impact: In the days following publication of this report, several universities uploaded missing clinical trial results.]
Published by TranspariMED and UAEM North America on 25 March 2019.
This report provides nine actionable policy recommendations for the European Commission, the European Medicines Agency (EMA), and EU national medicines regulators for improving clinical trial transparency.
It documents that in many cases, small and uncontroversial technical fixes could substantially improve clinical trial reporting on the EU clinical trials registry. None of the policy recommendations require changes to the legal framework. For example, the EMA could substantially boost reporting rates simply by emailing trial sponsors that have failed to post summary results within the mandated time frame.
Published by TranspariMED and Health Action International on 06 February 2019.
This report assesses the progress 27 UK universities made in reporting missing clinical trial results onto registries between November 2018 and January 2019. It finds that eight universities made progress, but the majority had not yet uploaded additional results.
In total 1,671 UK university clinical trials are still missing results on registries. Around 800 of these trials, many of them funded with public money, are in danger of becoming research waste.
Covered by the Daily Telegraph
Published by TranspariMED and UAEM UK on 24 January 2019.
This policy paper warns that progress on the Sustainable Development Goals is threatened by the current lack of transparency in clinical trials, hindering the attainment of seven out of 13 health targets. Global health bodies, donors and health agencies, including those in the Global South, cannot reliably determine the comparative cost-effectiveness of different treatment options. This leads to suboptimal allocation of scarce public health funds, undermines pandemic preparedness, and directly harms individual patients. Donors can help to resolve the problem by insisting that medical research they support follows WHO best practices, funding systematic efforts to retrospectively publish the results of unreported clinical trials, and supporting research and advocacy on clinical trial transparency
Published by the U4 Anti-Corruption Resource Center on 24 September 2018.
This paper analyses six case studies in which opacity in medical research has directly harmed patients, taxpayers and/or investors, and illustrates how these harms could have been avoided through trial registration, results posting, and/or full disclosure of trial reports.
Published on 28 April 2017
QUEST Clinical trial reporting workshop for universities
Complete presentations and materials of a one-day workshop for European universities. Covers policies, setup of institutional systems, and tips and tricks for managing EU and US registry entries.
How we uploaded 103 trial results: King's Health Partners case study
In this Q&A, a large UK trial unit explains how it systematically cleared its backlog of unreported trials on EudraCT. Contains useful guidance on systems and processes, and time/cost estimates.
Achieving excellence in clinical trial reporting: Nottingham Uni case study
In this Q&A, the University of Nottinham in the UK explains how it tackled its unreported trials, and provides useful advice to other universities across Europe.
Best practices checklist for clinical trial transparency
Research funders and clinical trial sponsors, including universities, can use this checklist to identify and address gaps in their current clinical trial policies. The checklist is based on WHO best practices. Click on the image below to download as PDF.
Clinical trial registration and reporting rules - a quick primer
Many universities do not fully understand their responsibilities related to clinical trial registries. Click on the image below for a brief summary of basic registry rules and global best practices.
Reporting clinical trials on registries – University of Bristol case study
This case study explains how universities can successfully tackle their unreported clinical trials, and the challenges that may entail. Covers policies, processes, systems, and resource requirements, plus key lessons learnt.
Managing trial registry entries with limited resources – LSTM case study
Liverpool School of Tropical Medicine explains how it manages its small portfolio of clinical trials, and how it sends email reminders to individual researchers to improve compliance rates.
European Union tutorials and training materials
This letter by European authorities contains a list of tutorials, training materials and other resources to assist trial sponsors in complying with EU trial registry reporting requirements.
How to get all clinical trials reported – guide for German universities
This presentation explains how German universities can ensure that all clinical trials are registered and promptly reported. Presents baseline data on current university performance, provides step-to-step guidance on fixing the problem, and discusses key lessons learnt by other institutions.
Inputs into policy making processes
Submission to the UK House of Commons Science and Technology Committee’s enquiry into clinical trial transparency, 06 Nov 2019
Recommends creating a legal obligation to register all trials and report results. 28 May 2019
Sets out eight transparency benchmarks for the UK's proposed national strategy. 03 May 2019
Notes the failure of the draft Research Integrity Concordat for UK universities to identify 'silent outcome switching' as a form of research misconduct, 14 March 2019
Policy proposal outlining how NHS Improvements can ensure that individual NHS Trusts report missing clinical trial results, 26 November 2018 (with HealthWatch and JustTreatment)
Comments provided to FDA on its draft guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank”, 15 November 2018
Feedback provided to Britain's public research funder NIHR on its proposed new clinical trials policy, 21 September 2018
Submission to the UK House of Commons Science and Technology Committee’s enquiry into research integrity, 17 June 2018
Submission to the UK House of Commons Science and Technology Committee’s enquiry into research integrity, 02 January 2018
Co-signed by STOPAIDS, HealthWatch UK, and Universities Allied for Essential Medicines UK
Submission to the UK House of Commons Health Committee’s inquiry into “Brexit – medicines, medical devices and substances of human origin”, 24 November 2017
Co-signed by HealthWatch UK and Universities Allied for Essential Medicines UK
Short policy brief setting out the case for comprehensive nationwide trial auditing by the UK’s Health Research Authority, 09 November 2017
Submission to the UK House of Commons Science and Technology Committee’s inquiry into research integrity, 05 October 2017
Co-signed by HealthWatch UK, UAEM UK, and Dr Simon Kolstoe
Submission to OECD consultation on Sustainable Access to Innovative Therapies, 28 April 2017
Co-signed by the AllTrials campaign
Articles and op-eds
Trials and errors
Fabian Society, 06 December 2019
Common sense wins out as a quiet revolution sweeps across the NHS
Public Sector Focus, 27 June 2019
How safe are our drugs?
New Economics Foundation blog, 22 March 2019 (with Adrian Bua from NEF)
Medical research waste: expensive to ignore, cheap to fix
Reform think tank blog, 29 January 2019 (with Rachel Cooper from Transparency Int.)
European countries must take action on unreported clinical trials
Policies for Equitable Access to Health (PEAH), 21 November 2018
Crackdown on unreported trials is good news for researchers
Research Fortnight, 14 November 2018
Transparency can help the NHS save money and improve patient care. Here’s how.
Reform think tank blog, 07 November 2018 (with Rachel Cooper from Transparency Int.)
More Transparency Is Needed to Fight Grand Corruption in the Pharmaceutical Sector
The Global Anticorruption Blog, 27 June 2018
Waste in Medical Research Threatens Sustainable Development Goals Health Targets
Policies for Equitable Access to Health (PEAH), 07 May 2018
National Institute of Mental Health Violates Law on Posting Clinical Trial Results
Mad in America, 19 March 2018
An Open Letter in Support of FDA’s Clinical Study Report Pilot Project
The BMJ, 23 January 2018 [co-signatory]
Brexit threatens progress on opening up clinical trials
Research Fortnight, 22 November 2017
Where's the data? Missing trial results undermine pandemic preparedness
Devex, 14 November 2017
Clinical trials transparency at UK universities: problems and solutions
HealthWatch UK newsletter, issue 106, autumn 2017
Grantees, Reveal Thy Findings: A Push by Funders for Transparency in Medical Research
Inside Philanthropy, 28 July 2017
Medical research in Bristol violates international transparency guidelines
Bristol Cable, 20 July 2017