TranspariMED clinical trial transparency

22 Jan 2020

A new study has found that 1,523 clinical trials of medicines and medical devices have failed to make their results public on the United States database due to the FDA’s failure to enforce a key medical transparency law.

There is overwhelming evidence that hidden clinical trial results harm patients and undermine public health.

Nonetheless, the team of researchers from the Univer...

22 Jan 2020

A landmark ruling on access to information about medicines today upheld independent scientists’ access to detailed information on the effects and harms of drugs taken by patients across Europe.

The documents in question, Clinical Study Reports (CSRs), provide a highly detailed picture of the design, conduct, analysis and findings of clinical trials, including data on the positiv...

10 Jan 2020

The Director General of the Italian Medicines Agency AIFA, Dr. Luca Li Bassi, outlines his agency's plan to improve clinical trial reporting and enhance the transparency of markets for drugs, vaccines and health technologies in this guest blog.

"The availability and full access to transparent information on clinical trials contributes to the protection of public health as w...

10 Jan 2020

Many German universities struggle to navigate the complexities of clinical trial reporting. This blog post discusses five common misconceptions, and suggests how universities can improve their performance.

But first some context:

Current university reporting performance is weak because there has been a diffusion of responsibilities within institutions and no clear oversight. In a...

7 Jan 2020

Europe’s largest medical association and a member of the European Parliament have urged German medicine regulators and universities to improve clinical trial reporting.

These calls for greater transparency come in the wake of a report showing that 445 clinical trials of medicines run by German universities are missing results on the European database EudraCT, in violation of lon...

5 Jan 2020

The UK Health Research Authority yet again seems poised to let patients down.

A document that appeared online in December suggests that the UK's medical research ethics regulator is determined to let clinical trial sponsors off the hook for failing to adhere to its own rules on clinical trial registration and reporting - defying the wishes of patients, parliament, and the wider...

30 Dec 2019

German universities have failed to make public the results of 445 clinical trials of medicines on a European database, in violation of European Union transparency rules, a report released today shows.

The outcomes of many of those trials remain completely unpublished and are in acute danger of becoming costly research waste.

German universities’ failure to adhere to scientific b...

19 Dec 2019

The UK government today announced plans to develop a

“streamlined, internationally competitive approach to the licensing and regulation of innovative medicines and devices, to give patients access to the best possible treatments and support the UK’s life sciences industry.”

Currently, most of the UK regulatory framework for drugs and devices is set by Brussels.

Post Brexit, depen...

19 Dec 2019

A lawsuit aiming to prevent the release of drug safety data threatens patients and public health across Europe, 31 patient and public health groups from across Europe warn in an open letter published today.

UPDATES January 2020:

30 Nov 2019

While universities in other countries are rapidly progressing in making their clinical trial results public, some universities in Germany still lag far behind.

Data from the EU Trials Tracker shows that the five worst performers in Europe are all German universities. Between them, these universities have sponsored 95 clinical trials that are due to post results onto the European...

25 Nov 2019

In this guest blog, Marc Taylor, Chair of the ISRCTN clinical trial registry, explains how the registry actively contacts researchers to remind them to update trial data and report study results, and has worked to make trial registration and reporting easier for users. ISRCTN is currently seeking feedback on how to further improve its services.

The ISRCTN clinical trial registry...

22 Nov 2019

The Association of the British Pharmaceutical Industry (ABPI) identifies “high standards for transparency” as one of seven key factors required to maintain the UK’s position as an "attractive destination for global investment in the sector".

According to a new policy paper published by ABPI:

A key element of research transparency is registration and reporting on international da...

21 Nov 2019

Irish medical schools have made the results of over 85% of their clinical trials available on the European trial registry, making Irish universities the strongest transparency performers in the whole of Europe.

Irish universities’ reporting rate of 85.7% places it ahead of academic institutions in the UK, which have uploaded the results of 72.1% of their trials. In contrast, les...

19 Nov 2019

In our recent systematic review of 204 clinical trials involving venous leg ulcers published in 76 journals since 2001, we found that over 80% of trials had not been registered.

This included trials of drugs, medical devices, and other interventions.

Only 38 of the trials in our review reported registration, while 166 trials were not registered. Registration rates have been incr...

8 Nov 2019

Failure to register and report clinical trials is not a victimless crime. It harms patients, undermines public health, slows down medical progress, and wastes public funds.

Nonetheless, not a single institution has ever been fined, anywhere in the world, for violating universally recognised ethical obligations.

During a recent parliamentary hearing in the UK, the issue of sanctio...

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