Clinical trial data transparency reaches record levels
Transparency of data from pharmaceutical industry-sponsored clinical trials has reached record levels. A recent study has shown that 93% of all such trials, relating to medicines approved by the European Medicines Agency (EMA) in 2014, published results within 12 months of trial completion or regulatory approval. This contrasts with a disclosure rate of just 71% in 2009.
In recent years there has been a drive within the scientific community and among regulators to improve the transparency of clinical trials and to increase the speed of data publication. Indeed, most of the top 25 pharmaceutical companies have publicly-available data transparency policies and have pledged to make all summary results available, although some variability remains in the policies’ scope.
This recent study, sponsored by the Association of the British Pharmaceutical Industry, was the final extension of three previously reported studies and looked at the 12-month and overall disclosure rates for results of clinical trials for the 32 new medicines approved by the EMA in 2014. Disclosure was defined as publication on a registry or in the scientific literature. Of the 542 clinical trials relating to the 32 medicines, results from 505 (93%) were disclosed within 12 months of trial completion or regulatory approval. Results from 518 (96%) had been disclosed by the end of the analysis period (31 July 2016).
The study authors, Deane & Porkess, credit existing laws and routine registration of all clinical trials for this improvement in data transparency. As disclosure rates head towards 100%, and clinical research embraces the use of “big data”, real world evidence and personalised medicine, the authors urge industry to maintain this transparency.
Summary by Philippa Flemming PhD, CMPP from Aspire Scientific
CORE Reference was a 2-year (May 2014 – May 2016) pro bono joint endeavour by EMWA and AMWA to develop an open-access resource to support authoring of disclosure-ready clinical study reports (CSRs).
Full resources and a complete explanation of the project are available at: http://www.core-reference.org. In particular, the launch paper, explains the project succinctly: http://dx.doi.org/10.1186/s41073-016-0009-4
CORE Reference is the only resource that we know of that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure. CORE Reference guides medical writers on proactive CSR text authoring that maintains data utility for the regulatory review version CSR, and results in minimal redactions for the public disclosure version CSR.
In January 2018, CORE Reference downloads exceeded 10,000. It is clear from comments posted at: http://www.core-reference.org/adoption-and-use/ that CORE Reference is not only useful for CSR authoring, but has wider application for the preparation of other clinical-regulatory documents for public disclosure.
Download CORE Reference at: http://www.core-reference.org/core-reference/
Dr Sam Hamilton