The ABPI is hosting a workshop to facilitate discussions on how best to address the issue of historical data and disclosure requirements on Thursday 21 March.

 

The event ‘Fulfilling a commitment to transparency while facilitating further research in the UK’ aims to meet two distinct needs – firstly, improve transparency for patients, public and health care professionals in general and secondly, access to the relevant data that are necessary for the advance of certain types of research.

The workshop will bring together a wide range of experts – particularly statisticians, data managers, documentation experts and those that produce, analyse and interpret clinical trial data.

Attendees will debate the specific issues relating to the definitions of what the pharmaceutical industry specifically means by a ‘CSR’, and what data is needed for systematic review and meta-analysis of both non-commercial and commercial studies.

Discussions at this workshop will act as: 

  • a familiarisation exercise for UK stakeholders with the different terminology used when discussing reporting of clinical trial results and the potential implications for industry of disclosure of each type of report
  • a forum for statisticians and key experts to agree on some terms and possible proposals the industry could offer with regards to release of trial results for the purposes of transparency and/or research
  • a sounding board to help inform some of the discussions in Europe, as some of the ideas generated could feed into the European Medicines Agency’s working groups.

The workshops were announced by ABPI Chief Executive Stephen Whitehead together with new measures to monitor compliance to the clinical trial transparency provisions contained in the ABPI Code of Practice.

For more information about the workshops, please contact Dr Emma- Louise Radway-Bright, Clinical Development Manager (email: getintouch@abpi.org.uk).

 
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