Ahead of meetings this week that will decide the fate of clinical trials regulation in Europe a group of European medical and patient organisations and the AllTrials campaign have sent a briefing document (PDF) on Clinical Trials Regulation to a number of prominent European contacts. The briefing explains the importance of retaining proposed amendments which support clinical trial transparency in the draft regulation. A series of trilogue meetings relating to the draft legislation began last week, and we understand that transparency will be discussed in the coming meeting on Wednesday 13th November. A decision on the Clinical Trials Regulation is expected on 12th December so the next four weeks are crucial.
The 19-page briefing document (PDF) which was sent to permanent representatives, health attachés, secretaries, and a number of MEPs addresses each relevant amendment, citing both the proposed text along with an explanation of its importance. It also contains a two-page summary of clinical trials and why the reporting of clinical trial results is a public interest imperative.
If your organisation would like to sign the briefing document which we intend to send again nearer to the 12th December deadline please get in touch. It is particularly important if you are a European based organisation.
Finally, thank you again to everyone who wrote to their European health minister in the last few weeks urging your country to support specific amendments in favour of clinical trial transparency – your letters may be pivotal over the next four weeks.