Pharma Requests Pilot To Test Public Value Of EU Guide On Plain Language Summaries

 
• By Vibha Sharma
  
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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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Complying With Draft EU Guide On Lay Clinical Trial Summaries Will Be Expensive • Source: Shutterstock

Complying with the European Commission’s draft guideline on presenting the summaries of clinical trial results to the public in plain language format would require “significant additional resources” from drug companies, especially small and medium-sized enterprises who conduct hundreds of trials in several regions of the globe, pharmaceutical industry trade group EFPIA has warned.

Based on its experience of developing and testing lay summary documents with patient groups on a voluntary basis, EFPIA said...

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