The Good Clinical Trials Collaborative has submitted responses to the draft ICH Good Clinical Practices (Annex 2) guidelines to regulatory bodies around the world.

Read the Collaborative’s commentary here

Submissions have been made to regulators in Japan (MHLW/PMDA), China (NMPA), UK (MHRA), US (FDA), Singapore (HSA), Saudi Arabia (SFDA), Chinese Taipei (TFDA), Switzerland (Swissmedic), Brazil (ANVISA), Canada (Health Canada) and the European Union (EMA). These submissions are part of the ICH’s call for public comments on Annex 2, which is scheduled for publication later this year.

The Collaborative’s response is informed by the principles for good clinical trials as described in the World Health Organization (WHO) Guidance for Best Practices for Clinical Trials and draws the extensive experience of designing, conducting and participating in innovative clinical trials from across members of the Good Clinical Trials Collaborative.

Our commentary emphasizes the need for compliance with the Principles of Good Clinical Practice, and recommends adapting the Guideline’s wording to promote informative, actionable safety reporting. The response also proposes that Annex 2 sets more practical expectations on accessing real world data sources.

We recommend that the updated guideline promotes the flexible assignment of roles and responsibilities, as this can increase the quality and efficiency of a trial. Our letter also underlines the need for the draft guideline to reference engagement with patients and communities, and to ensure the guideline’s wording on the involvement of healthcare professionals sets proportionate expectations.

Nick Medhurst, Head of the Good Clinical Trials Collaborative, said:

“Our goal is to make good clinical trials easier to do. By supporting the development of a fit-for-purpose Annex 2, we hope the final guideline can help more trials choose innovative and pragmatic approaches that speed up access to robust, reliable evidence while protecting the rights and well-being of participants and the public every step of the way.”

The Collaborative extends its profound gratitude to the many organisations and individuals who volunteered their expertise and time to support this effort.

You can read the full response here