Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries
The European pharmaceutical trade group EFPIA says an “initial pilot” program should be launched to test the value and impact of the draft EU guideline on presenting lay summaries of clinical trial results. The group believes that the guideline should be reviewed following the pilot, as complying with it in its current form would result in companies shelling out “significant additional resources.”
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Sponsors are being urged to plan early and involve patients in every aspect of preparing the plain language summaries of clinical trial results that will become mandatory when the EU Clinical Trials Regulation starts applying from December 2021.
With a clear implementation date now in sight for the EU Clinical Trials Regulation, the European Commission is focusing its efforts on finalizing additional guidance and templates to support compliance. The pharmaceutical industry wants access to a test version of the new CT portal so that companies can make the necessary adjustments to their own systems.
Industry urges US FDA guidance on developing plain language summaries, which could help improve the release of clinical trial results to patients.