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 companies would have to put in additional resources to produce...
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