The main current ICH regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs) are ICH E6 (effective 1996) and ICH E3 (effective 1995). EMWA has initiated collaboration with many stakeholders, including professional associations, regulators, and key industry participants, to review both guidelines in a 2-year project that began in May 2014. The EMWA-initiated Budapest Working Group (BWG) – chaired by Dr Sam Hamilton, EMWA Vice President – comprises experts in ICH E3, ICH E6, CSP and CSR templates, with experience in disclosure and transparency, and a strategist who is working with partner and stakeholder organisations. With their involvement from the outset, one aim of this project is to encourage participation amongst all affected parties, to ensure that the anticipated recommendations address the needs of the broadest possible community, following developments over almost 20 intervening years since these guidelines were first issued.
The review will not only align the guidelines with current practices, and increase transparency in the reporting of clinical trial data, but will focus on protecting the anonymity of trial participants, since CSRs are to be made publicly available. This is a major step along the way to ensuring that all sponsors of clinical trials adhere to the principles of responsible clinical trial data sharing.
Sam Hamilton (EMWA Vice President and BWG Chair) and Art Gertel (EMWA Fellow and BWG member) will present their first publication of the project at the EMWA Conference in Florence on Friday 07 November 2014, 12.45 – 13.20. For more information on the conference visit: http://www.emwa.org/EMWA/Conferences/EMWA/Conferences/Conference_Overview.aspx.
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