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.
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
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.
COUNTRY AND REGIONAL REPORTS
This report documents extremely low reporting rates for drug trials run by Dutch trial sponsors and widespread data quality problems.
The report reviews 1,609 drug trials run by the country's most active trial sponsors, predominantly universities. It finds that on the European trial register, results are available for only 21 of these trials. The report also documents the proliferation of old trials that are still falsely marked as 'ongoing', which makes it more difficult for Dutch patients to find suitable trials to enrol in.
Covered by Dutch national newspaper NRC
Published by TranspariMED and Health Action International on 20 August 2020.
This report assesses the risk of research waste across 118 clinical trials of possible COVID-19 drug treatments currently being conducted in Europe.
The report shows that the majority of COVID-19 drug trials in Europe are run by trial sponsors who are inexperienced and/or in violation of European transparency rules. This poses a threat to the accuracy and utility of data on COVID drug research, generates a high risk of research waste, and undermines the global search for safe and effective COVID-19 drugs.
Covered by STAT News
Published by TranspariMED on 18 June 2020.
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 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 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 by UK charity HealthWatch provides an overview of medical device regulation, evidence requirements and the transparency of evidence in the context of the incoming EU Medical Device Regulation and Brexit.
It discusses the challenges of designing clinical trials for medical devices, and registration and reporting of device trials in the new EUDAMED database. Authored by TranspariMED founder Till Bruckner in 2019.
This report by UK charity HealthWatch compares the levels of transparency across three different health technology assessment agencies in Europe: NICE (UK), IQWIG (Germany) and HAS (France).
Comparing assessments of palbociclib for breast cancer, it finds overall high levels of transparency, but notes with concern that NICE sometimes redacts efficacy data from clinical trials.. Authored by TranspariMED founder Till Bruckner in March 2020.
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