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Clinical trials transparency and access to data

 

 

 

 

 

 

 

 

 

 

Latest update - 28.8.14

Release of the analysis report of 'Faculty of Pharmaceutical Medicine survey of members on transparency in clinical trials'

The report, based on the results of the survey undertaken at the end of 2013, is available to download here.

Download the Press Release here.

Press on the report:

 


 

The issue of transparency of clinical trial data is currently very high on the agenda and the Faculty is active in the debate and involved with many of the workstreams that have been established to devise new policies and frameworks for data release. A number of initiatives and actions have already been taken to increase accessibility of information about clinical trials and their results, notably ‘clinicaltrials.gov'. The debate has now moved further to how effective these systems are and what further steps are needed to optimise the release of clinical trial results and data.

In line with the Guiding Principles for Pharmaceutical Physicians the Faculty has taken a positive and progressive stance on transparency and we are keen to proactively lead the debate in this area. We believe that increasing the transparency of clinical trials and easing access to data will ultimately be beneficial for patients. A change in legislation and policy could:

  • Facilitate the meta-analysis of data to provide a better understanding of clinical efficacy and safety, even helping to validate new targets for medicines development
  • Raise the overall standard of clinical research governance
  • Avoid replication of clinical trials (reducing the hazard for volunteers and patients involved in clinical research)
  • Increase scrutiny providing all stakeholders with protection from publication bias on the part of researchers, sponsors, and journal editors

However, there could also be risks and concerns related to increased access to data, including:

  • Biased or inappropriate methodology applied to secondary analyses leading to misinformation reaching patients, clinicians, the general public and media
  • Breaches of individual patient confidentiality and inappropriate use of the data
  • The commercial competitiveness of companies may be harmed

The Faculty has:

  • Submitted written evidence to the House of Commons Science and Technology Select Committee's Inquiry into Clinical Trials
  • The President of the Faculty, Dr Keith Bragman, gave oral evidence to the Select Committee on the 13th March 2013. Watch the session here (starts at 1h 24m).
  • Signed the AllTrials campaign on 13th March
  • Been represented on 3 of 5 European Medicines Agency advisory groups, looking at different aspects of release of clinical trial data
  • Attended meetings organised by AllTrials and the Wellcome Trust


FPM survey on access to clinical trials results and data

Survey open from 23rd September to 28th October 2013

In order to inform our ongoing work in this area the Faculty has run a survey of our membership to better inform our decision-making on these challenging issues. The survey will evaluate our members' opinions on how a system can be developed that will enable the safe and responsible dissemination of clinical trial results and access to data. The process will need to balance the potential positive and negative effects described above, and will ultimately ensure that the best possible science results in the best possible treatments for patients.