Science and Technology CommitteeSupplementary written evidence submitted by Sense About Science

This note is in response to a request from the Chair to Tracey Brown during the oral evidence session on 15th May to clarify differences between oral and written evidence.

Since we submitted written evidence in February 2013 detailed discussions on what is needed for clinical trial transparency have been going on among organisations who have signed up to the AllTrials campaign. These include a Wellcome Trust hosted workshop; a discussion of clinical trial transparency in non-commercial trials hosted by Glenis Willmott MEP; and a series of stakeholder meetings run by the Health Research Authority as it drafted the Transparent research report as well as informal discussions among members of the campaign.

There are four levels of information sharing:

1.Study registration.

2.Summary results.

3.Clinical study reports and their equivalents.

4.Full individual patient data from clinical trials.

The information may be contained in a range of formats depending on who is generating it and for what purpose. The reality is that there is overlap between levels 2–4. Clinical study reports may contain appendices and sections with some individual patient data for example.

Level 1 is a register of all trials that have taken place. Registration of a trial includes setting out what the trial is for and the protocol. Trial registration is often ignored.

Level 2, summary results, sets out what was found and what was done in summary form. This could be in a journal paper or the results section of a register, for example www.clinicaltrials.gov. These are still not universally shared. Summary results should include trial information such as participant details and recruitment; protocol; primary and secondary endpoints measured; details of statistical analysis; and so on.

The AllTrials campaign is calling for all clinical trials to be registered and the results reported therefore we are calling for levels 1 and 2. It is already a requirement under the Helsinki convention for anyone who conducts a trial to register it and publish a summary of what was found. This obligation is routinely not met.

Level 3 clinical study reports (CSRs) are generally produced for licensing and regulatory purposes. We recommend that anyone who produces or has produced an ICH-GCP standard CSR should have to share this, redacted to the same extent as the European Medicines Agency redacts the CRS it releases. If the trial sponsor is not planning to go down the regulatory route then they should not have to produce a full ICH-GCP standard CSR.

May 2013

 

Tracey Brown asked me to email you about things she didn’t get a chance to mention at her oral evidence session on 15 June and I thought that these are be points it would be useful to put to the Ministers on Monday.

Will the UK Government make a clear statement in support of transparency along the lines of what was voted for in Brussels yesterday? A committee of MEPs voted yesterday to add amendments to the clinical trials regulation in support of transparency and data sharing including a requirement that all clinical trials conducted in the EU must be registered and summary results reported within a year of their end with financial penalties for those who don’t comply, and a statement that information in a clinical study report should not be considered commercially confidential. Will the UK Government support that?

Will the UK Government intervene to support the European Medicines Agency’s policy of openness? The EMA has had injunctions issued against it in two court cases brought by pharmaceutical companies AbbVie and InterMune who challenged the Agency’s policy to give access to CSRs it holds. It has been left to the Agency’s lawyers to decide that the EMA should not release anymore CSRs it holds from any trials. The EMA has told us that organisations including the European consumer group BEUC and the European ombudsman and several member states have applied to intervene in the court cases in support of the EMA. Will the UK government?

30 May 2013

Prepared 16th September 2013