Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop
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...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-10-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001090 |
| _version_ | 1798001159457210368 |
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| author | Alessandra Mancino Enrico Crea Monica Messina Marco Ferrante Maria Valeria Feraco Paola Fazi Marco Vignetti |
| author_facet | Alessandra Mancino Enrico Crea Monica Messina Marco Ferrante Maria Valeria Feraco Paola Fazi Marco Vignetti |
| author_sort | Alessandra Mancino |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T11:31:41Z |
| format | Article |
| id | doaj.art-8fb236c3cd414d18a76a85ceb82be01a |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-11T11:31:41Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-8fb236c3cd414d18a76a85ceb82be01a2022-12-22T04:26:06ZengElsevierContemporary Clinical Trials Communications2451-86542022-10-0129100992Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loopAlessandra Mancino0Enrico Crea1Monica Messina2Marco Ferrante3Maria Valeria Feraco4Paola Fazi5Marco Vignetti6Fondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, Italy; Corresponding author.Fondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, ItalyFondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, ItalyStudio Legale FLC, Rome, ItalyStudio Legale FLC, Rome, ItalyFondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, ItalyFondazione G.I.M.EM.A.- Franco Mandelli Onlus, Rome, Italy; Department of Translational and Precision Medicine, Hematology, Sapienza University of Rome, Rome, ItalyRegulation (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.http://www.sciencedirect.com/science/article/pii/S2451865422001090Clinical trialsEuropean regulationCo-sponsorshipNot-for-profit clinical trialsAcademic clinical researchLegislation |
| spellingShingle | Alessandra Mancino Enrico Crea Monica Messina Marco Ferrante Maria Valeria Feraco Paola Fazi Marco Vignetti Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop Contemporary Clinical Trials Communications Clinical trials European regulation Co-sponsorship Not-for-profit clinical trials Academic clinical research Legislation |
| title | Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop |
| title_full | Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop |
| title_fullStr | Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop |
| title_full_unstemmed | Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop |
| title_short | Regulation 536/2014 and its beneficial impacts on academic clinical research in Italy. Closing the loop |
| title_sort | regulation 536 2014 and its beneficial impacts on academic clinical research in italy closing the loop |
| topic | Clinical trials European regulation Co-sponsorship Not-for-profit clinical trials Academic clinical research Legislation |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001090 |
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