Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop

Alessandra Mancino; Enrico Crea; Monica Messina; Marco Ferrante; Maria Valeria Feraco; Paola Fazi; Marco Vignetti

doi:10.1016/j.conctc.2022.100992

Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop

Contemp Clin Trials Commun. 2022 Sep 5:29:100992. doi: 10.1016/j.conctc.2022.100992. eCollection 2022 Oct.

Authors

Alessandra Mancino¹, Enrico Crea¹, Monica Messina¹, Marco Ferrante², Maria Valeria Feraco², Paola Fazi¹, Marco Vignetti^{1

3}

Affiliations

¹ Fondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, Italy.
² Studio Legale FLC, Rome, Italy.
³ Department of Translational and Precision Medicine, Hematology, Sapienza University of Rome, Rome, Italy.

Abstract

Regulation (EU) No 536/2014 (Clinical Trial Regulation, CTR) offers two precious tools to academic clinical research in Italy: - The right to transfer not-for-profit clinical trials data and results for registration purposes, and co-sponsorship. - The right to transfer data reduces the time needed to make innovative therapeutical agents and therapies accessible to the patient. Co-sponsorship, on the other hand, allows the establishment of a partnership between entities with different missions, ideals and attitudes, sharing - nevertheless - the same ultimate goal: meeting the patient's medical needs. Co-sponsorship facilitates collaboration among experts, which allows knowledge sharing, thus guaranteeing, to each contributor, recognition for their own contributions to a complex activity such as a clinical trial. However, the above-mentioned Regulation poses important challenges, especially in terms of infrastructural efficiency, which is demanding, especially for those entities suffering organizational inadequacies: unfortunately, inefficiency is sometimes a structural problem in the academic clinical environment. This publication focuses on the specific innovative aspects introduced by CTR. It also highlights the possible difficulties to be addressed by their implementation.

Keywords: Academic clinical research; Clinical trials; Co-sponsorship; Data transfer; European regulation; Legislation; Not-for-profit clinical trials.