TranspariMED clinical trial transparency

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The outcomes of many of those trials remain completely unpublished and are in acute danger of becoming costly research waste.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

7 Nov 2019

Many scientists secretly believe that politicians are too daft to understand the complexities and challenges of doing science well.

Last week, UK parliamentarians proved them wrong when they quizzed universities and regulators about their progress on making more clinical trial results public.

Below nine takeaways from the session.

Back story: In 2018, politicians were dismayed t...

1 Nov 2019

Evidence requirements and transparency of evidence for medical devices will probably improve under the incoming EU Medical Device Regulation, but will continue to fall short of the standards applied to medicines, a paper published by the British charity HealthWatch has found.

Issues covered in the paper:

  • Strengths and weaknesses of the Medical Device Regulation

  • Third par...

1 Nov 2019

While large pharmaceutical companies typically do well at making clinical trial results public on registries, many small companies still fall short of minimum regulatory standards.

The data below shows clinical trial reporting performance in the EU and US broken down by sponsor type:

  • In Europe, 66% of trials run by small companies are missing results, versus 76% of trials run...

31 Oct 2019

Dutch universities violate clinical trial transparency rules on a large scale, new data gathered by Universities Allied for Essential Medicines (UAEM) and Health Action International shows.

Dutch universities have sponsored 1,140 clinical trials, but have posted results for only two (!) of these trials. 

Furthermore, only 25 of the 1,140 clinical trials are listed on the Europea...

29 Oct 2019

The European Medicines Agency has announced plans to make it easier for universities and smaller pharma companies to upload the results of clinical trials of medicines onto the European trial registry EudraCT.

Posting results of onto the registry has been mandatory since 2014, but many institutions running clinical trials are violating this transparency rule, leaving large gaps...

25 Oct 2019

On Tuesday, UK parliament will assess progress in clinical trial reporting by universities and NHS Trusts. The session follows up on parliament’s 2018 enquiry into clinical trial transparency, and will be streamed live from 09:30 onwards.

Update: A transcript of the session is now available online.

Meanwhile, new compliance data shows substantial but uneven progress by non-commer...

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