Clinical Trial Transparency: implementation and perspectives

The conference Focus on Clinical Trial Transparency & Lay Person Summary, moderated by Massimo Zaninelli (Maxer Consulting) took place on November 24. The speakers first outlined the main changes introduced by EU Regulation 536/2014 regarding clinical trials (Antonio Ferrari – EryDel SpA) and the implementing rules established by the Policy EMA 0070 about the publication of the clinical trials (Marisa Minetti – Chiesi Farmaceutici SpA) .

Erika Ornago and Paola Roma (Maxer Consulting) illustrated the case history on the publication of phase 1, 2 and 3 studies on various Chiesi Group products, reporting on time the limits and the problems that emerged from the use of the EudraCT platform, now being restored by EMA.

Davide Benedetti (Menarini IFR srl) exposed the company point of view about the use of the platform during the loading of the full data set of clinical trials.

Antonio Ferrari then described the debate that is characterizing the introduction of the Lay Person Summary, an instrument mentioned in the EU in Annex V of Regulation 536/2014 as a tool that complements the publication of studies on the platform EudraCT. Massimo Zaninelli proposed an approach to the drafting of the Lay Person Summary based on a method that emphasizes, in a logical and documented way, the patients’ knowledge and interests.

The subsequent debate highlighted the relevance of the topics, expressing the hope that the construction of rules designed to promote clinical research and publicize its findings does not cause excessive tightening procedures, the effects of which would be more damaging than constructive for the entire pharmaceutical sector.