The proposal for the revision of the Clinical Trials Directive will be discussed tomorrow (29th May) in the Envi Committee of the European Parliament. On transparency and disclosure of trial results I am not hearing good news.
The rapporteur, Glenis Wilmott, made a good proposal in her report – for the publication of a Clinical Study Report within one year of the completion or termination of a clinical trial.
It seems this proposal has not enough support from other MEPS, particularly from the biggest group in the Parliament, the EPP, for which Philippe Juvin is the “shadow” rapporteur. Therefore a compromise is likely tomorrow.
If I understand correctly, and I may not, the compromise would require the publication of an extended summary of every trial and, for trials intended to be used to obtain a marketing authorisation, the publication of a Clinical Study Report within 30 days of the decision on the authorisation.
This “solution” is clearly not as good as Glenis Wilmott’s original proposal, and would have a number of bad effects.
It would delay the publication of Clinical Study Reports until after a decision on an authorisation.
It would also allow companies to conceal the full results of many trials, on the grounds that they were not intended to be used for a marketing authorisation. Suppose there are two medicines authorised for a particular condition and a trial was conducted to find out which was more effective – a good thing to know and in the interest of patients. This trial would not be intended to be used for a marketing authorisation and therefore there would be no requirement to publish a Clinical Study Report.
In another scenario, a company could postpone indefinitely the results of a trial it did not want to make public by claiming that it was intended to be used (some day) for a marketing authorisation.
It seems too that Clinical Study Reports would not have to be published for “academic” studies since these are often not intended to be used for a marketing authorisation. Some academic interests had expressed concern about having to publish a Clinical Study Report; this is a pity since academics above all should favour open science and open medicine. Moreover, there is often little difference in practice between many “commercial” trials and “academic” trials.
I may have got this wrong, and indeed I hope I have. If the compromise is along the lines that I fear the European Parliament will miss the chance to support a reform that is strongly in the interests of good science, good medicine and patients. ENDAuthor : Jim Murray