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Publicly-funded research: too opaque!

France's top clinical research institutions, like many public organisations or private foundations financing clinical trials around the world, are not up to the mark when it comes to clinical research transparency.

Clinical trial registries and availability of trial results are essential elements in the transparency of clinical research, transparency that is essential to ensure that scientific knowledge is not tainted by data retention.

Several international initiatives taken since 2000 recommend registration of clinical trials before they are initiated, including a description of the protocol; publication of the results; and access to individual patient data.

One study showed that among the world's top 18 public organisations or private foundations financing clinical trials, only 9 required registration of all trials, 8 required publication of at least a summary of the results, including 4 within the allotted time frame of 12 months, and only 2 required access to individual patient data.

The most transparent organisations were those of the United States, Britain, Canada, Germany and the European Commission. The French National Institute for Health and Medical Research (Inserm) and the National Centre for Scientific Research (CNRS) came in last, along with the Chinese Ministry of Health.

The shortcomings of the French organisations do not stop there. In April 2018, the CNRS published a triumphant press release applauding the results of a clinical trial of forigerimod in lupus. Paradoxically, on the same day, the share price of Immu-Pharma, the company that holds the commercial rights to this drug developed by the CNRS, fell by 77%. In fact, stock market analysts were not mistaken. The efficacy results for forigerimod were not statistically significant, a "detail" that had apparently escaped the CNRS.

These facts show that Inserm and CNRS are not up to the mark when it comes to clinical research transparency, whereas publicly-funded organisations, they should be setting an example.

©Prescrire 1 March 2019

"Publicly-funded research: too opaque!" Prescrire Int 2019; 28 (202): 83. (Pdf, free).

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See also:

Transparent, independent
health authorities:
The worldwide debate on
access to clinical trial data
(Advancing healthcare policy)

Clinical trials registries:
towards improved access
to therapeutic data
Prescrire Int 2008;
17 (98): 256-259.
Pdf, subscribers only

Clinical trials in France: too
many unpublished results
Prescrire Int 2006;
15 (85): 197.
Pdf, free