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.

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

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.

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Published on 28 April 2017

This background paper on medical device governance in the UK seeks to inform discussions at the HealthWatch Symposium 2019 on “Evidence, Healthcare and Medical Devices & Implants”, which will be held on 17 June 2019 in London.

The aim of the symposium is to clarify the current issues facing evidence based healthcare in the field of implants and medical devices, and to identify areas where HealthWatch and similar organisations might most productively concentrate their efforts.

The paper focuses on evidence requirements for medical devices in the UK in the context of the recent global Implant Files investigation and the incoming EU Medical Device Regulation. The latter is scheduled to come into force from May 2020.

Many of the world’s largest medical research funders still fail to ensure that clinical trial results are made public, new data show. Their lack of safeguards raises concerns that public money is being wasted while patients suffer harms due to systematic distortions in the medical evidence base.

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Only one funder worldwide, the UK’s National Institute of Health Research, has adopted all 11 research waste safeguards recommended by the World Health Organisation. Several funders, including the U.S. Centers for Disease Control, the Italian Ministry of Health, and Spain’s Instituto de Salud Carlos III, neither require their grantees to make all trial results public nor monitor whether they do so.

Last week, German and UK experts jointly explored policy options for ending research waste in clinical trials in Germany. This blog provides some highlights of the debate.

The video of the full event is now available on YouTube. 

The full transcript (both in German and in English) can be downloaded further below.

“If the time is not now, when then? We have a health minister who comes from a medical research background. He is a medical doctor. He has some experience in evidence based medicine.”
Stefan Sauerland, DnEBM

The majority of unreported drug trial results in Europe are now concentrated within just four countries, highlighting the strong differences in regulatory quality between European Union member states, a new report shows.

National medicines regulators that proactively chase up missing clinical trial results with pharma companies and universities have succeeded in significantly boosting reporting rates. This includes regulators in Germany, Austria, Denmark and Belgium. 

In contrast, the number of missing results has further grown in Italy and France. In Italy alone, an estimated 1,299 clinical trial results are now missing in violation of European transparency rules. 

Read more

The UK is on track to become the first country to finally fix the problem of unreported clinical trials. Here’s how the UK system works, in 153 words and 1 chart.

Fixing clinical trial registration

Ethics committees (about 60 countrywide) send the protocols of all studies that they approve to the Health Research Authority in London. Staff at the Health Research Authority (HRA) then directly register every clinical trial on the ISRCTN registry. After the trial has been registered, the principal investigator of the trial takes over registry management, and is responsible for keeping the registry entry updated and uploading the results.

The results of dozens of clinical trials involving thousands of American children have never been made public in violation of the law. 
The benefits and harms detected during those trials, which involved 3,627 children, remain completely unknown, leaving parents, doctors and medical researchers in the dark about the benefits and harms of potentially life-saving treatments. 

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UPDATE 24 January: FDA response added further below.
A report published today by the National Center for Health Research, Universities Allied for Essential Medicines and TranspariMED found that the results of 43 paediatric clinical trials subject to a U.S. federal disclosure law have never been made public, neither on a registry nor in the scientific literature.