Contemporary Clinical Trials Communications (Oct 2022)

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

Journal volume & issue
Vol. 29
p. 100992

Abstract

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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.

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