TranspariMED clinical trial transparency

24 Apr 2020

FDA secrecy surrounding falsification of data or violations in adverse event reporting detected during clinical trials is undermining the integrity of the scientific evidence base on drugs and medical devices, experts warn.

Writing in JAMA, they note that inspection reports compiled by the U.S. Food and Drug Administration are often kept from the medical research community,...

8 Apr 2020

Universities worldwide can now access a free software tool to improve their clinical trial reporting on the largest trial registry, the American 

According to a press release by TrialAssure, a specialist trial disclosure company:

"Academic institutions can sign up for a TrialAssure subscription specific to this program—at no cost— allowing users free acce...

5 Apr 2020

A data set released by the UK Health Research Authority provides a comprehensive overview of all 2,646 clinical trials that received ethics approval within the UK during the year 2019. The data offers meta researchers a unique opportunity to analyse an entire country’s clinical research activity.

In the UK, researchers must obtain ethics approval from one of the country’s region...

19 Mar 2020

A new project seeks to quantify research waste in the UK by checking whether 1,000 clinical trials have made their results public.

The project will examine interventional trials completed before 2016 that were run by twenty universities and NHS Trusts. It will focus on trials of medical devices and non-drug interventions, using manual searches to check whether they have made the...

In Denmark, sponsors that fail to report clinical trial results will soon face fines or even prison sentences, explains Lene Grejs Petersen of the Danish Medicines Agency in this guest blog.

The Danish medicines agency (DKMA) will further step up its efforts to improve the publication of results from clinical trials in Denmark.

In November 2019, DKMA published a statement highlig...

4 Mar 2020

The Medical Research Council has revealed details of how it monitors its grantees to ernsure that all clinical trials it funds are registered and report their results.

In doing so, the UK funding institution has essentially produced a detailed how-to manual that should be required reading for other medical research funders worldwide.

In 2017, major medical research funders from a...

2 Mar 2020

NICE redacted clinical trial data on cancer patient survival even though its counterparts in Germany and France made similar data publicly available, a report released today shows.

The report by UK charity HealthWatch reviews assessments of the use of the drug palbociclib (Ibrance) for advanced breast cancer conducted by three different European health technology assessment agen...

26 Feb 2020

A U.S. federal court has ruled that clinical trial sponsors – including pharma companies, device manufacturers and universities – must make public the results of hundreds of clinical trials conducted prior to 2017.

UPDATE 28 April 2020: The U.S. government decided not to appeal against this ruling. Sponsors are thus obliged to post the results of their clinical trials stretching...

24 Feb 2020

Austrian universities, hospitals and pharma companies have failed to upload the results of at least 273 clinical trials of medicines onto the European trial registry, a study released today by TranspariMED, Cochrane Austria and Transparency International Austria shows.

In total, 82% of due trial results are missing in Austria.

UPDATE: Following strong media coverage of TranspariM...

22 Feb 2020

Universities across Finland, Norway and Sweden have failed to upload the results of hundreds of clinical trials onto the EU Clinical Trial Register, in violation of EU transparency rules.

This is not a victimless crime.

Research whose results remain hidden benefits nobody, and makes no contribution to the discovery of new treatments and cures. Taxpayers’ money is wasted, trial pa...

4 Feb 2020

Pfizer, SanofiSunovion and Novartis have failed to make publicly accessible the results of six large-scale clinical trials of psychiatric drugs.

In the wake of a series of high profile scandals and court cases, large pharmaceutical companies have tried to rebuild trust with doctors and patients by posting the results of clinical trials onto public trial registries as and when...

30 Jan 2020

Eleven patient and health groups today call on the newly elected Chair of the House of Commons Science and Technology Committee, Greg Clark MP, to "continue engaging on the issue of clinical trial transparency in the new Parliament".

Thanks to the previous Committee's strong engagement during 2018 and 2019, UK universities in particular have become global leaders in clinica...

27 Jan 2020

Some university researchers still believe that if their clinical trial publishes its outcomes in a peer-reviewed journal, they do not also have to upload its summary results onto trial registries.

That is wrong. Here are the facts:

  • Both EU regulations and US law require the results of many (though not all) clinical trial results to be uploaded onto trial registries within 12...

27 Jan 2020

A new study has found that 62 clinical trials involving over 13,000 patients run by Polish academic medical centres have never made their results public.

CORRECTION 30 January 2020:

The original version of this blog incorrectly stated that the universities had acted as the sponsors of the trials. In fact, the universities had acted as research sites for the trials, which were spo...

23 Jan 2020

Cochrane Germany has issued a statement calling the failure by German universities to make clinical trial results public in line with European transparency rules "completely unacceptable".

The statement follows the release of a report by TranspariMED and BUKO Pharma-Kampagne in late December that showed that at least 477 clinical trials run by German universities were missing re...

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