TranspariMED clinical trial transparency

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...

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...

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