TranspariMED reports

The reports below document the financial and human costs of unreported trials, and compare the performance of universities in selected countries.

COSTS AND BENEFITS OF TRANSPARENCY

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.

 

The study was covered by the BMJ has been cited in the Lancet.

Co-published with Transparency International, Cochrane and CRIT on 12 December 2017. Also available in German language.

"CLINICAL TRIAL" TRANSPARENCY "transparency international" cochrane CRIT TranspariMED corrupt evidence stdy pdf

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.

Case studies:

  • Lorcainide

  • Avandia

  • Vioxx

  • Reboxetine

  • SSRIs (antidepressants)

  • Tamiflu.

Published on 28 April 2017

"CLINICAL TRIAL" TRANSPARENCY Lorcainide, Avandia, Vioxx, Reboxetine, SSRIs antidepressants Tamiflu deaths

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. 

U4 policy paper cover.jpg

COUNTRY AND REGIONAL REPORTS

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. 

Covered by Sueddeutsche Zeitung, NDR, Aerzteblatt and many others.

Published by TranspariMED and BUKO-Pharmakampagne on 30 December 2019. 

CTT at German unis report cover 20191230

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. 

Covered by Nature, BMJ, STAT News, and multiple national media outlets.

Published by TranspariMED and three European partners on 30 April 2019. 

EU unis report cover 20190430.jpg

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.]

 

Covered by STAT News, NatureEndpoints, and four other media outlets.

Published by TranspariMED and UAEM North America on 25 March 2019. 

CTT at US universities cover (March 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. 

TranspariMED - Research waste in trials

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. 

UK university progress June 2019 cover.j

OTHER REPORTS

Inputs into policy making processes

Clinical trial transparency: clarifications and additional information

  • Submission to the UK House of Commons Science and Technology Committee’s enquiry into clinical trial transparency, 06 Nov 2019

Comment on the proposed New Zealand Therapeutic Products Bill

  • Recommends creating a legal obligation to register all trials and report results. 28 May 2019

Position statement on the planned UK national clinical trial monitoring system

  • Sets out eight transparency benchmarks for the UK's proposed national strategy. 03 May 2019

Silent outcome switching in clinical trials

  • 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

A transparency blueprint for the NHS

  • Policy proposal outlining how NHS Improvements can ensure that individual NHS Trusts report missing clinical trial results, 26 November 2018 (with HealthWatch and JustTreatment) 

FDA must monitor clinical trial reporting and issue fines for violations of the law

  • Comments provided to FDA on its draft guidance on “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank”, 15 November 2018

Strengthening NIHR's clinical trial reporting policy

  • Feedback provided to Britain's public research funder NIHR on its proposed new clinical trials policy, 21 September 2018

Clinical Trial Transparency: Update on recent developments

  • Submission to the UK House of Commons Science and Technology Committee’s enquiry into research integrity, 17 June 2018

Clinical Trial Transparency: Progress since 2013 and Options for Auditing Trials

  • 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

Using Brexit to improve clinical trials regulation in the 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

 

The Case for a UK National Clinical Trial Audit System

 

  • Short policy brief setting out the case for comprehensive nationwide trial auditing by the UK’s Health Research Authority, 09 November 2017

A National Clinical Trial Audit System to Improve Clinical Trials Reporting

 

  • 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

 

Sustainable access to innovative therapies: The need to take action on clinical trials transparency

 

  • Submission to OECD consultation on Sustainable Access to Innovative Therapies, 28 April 2017

  • Co-signed by the AllTrials campaign

This site was designed with the
.com
website builder. Create your website today.
Start Now