Decentralized Clinical Trials in Italy: state of the art and future perspectives
Keywords:DCT, Decentralized Clinical Trial, Remote monitoring, e-consent, digital health
Clinical trials are an essential source of high-quality evidence for the assessment of efficacy and safety of healthcare interventions. Nowadays the main criticality of the traditional clinical trial model is perhaps the need to improve patient selection and management, in terms of initial identification, recruitment and retention.
Digital technology offers operational solutions that can facilitate many of the activities involved in clinical investigation. Decentralized Clinical Trials (DCTs) could be a new option that provides for the use of remote instruments/methods/activities in the different stages of a clinical trial, so that a range of procedures (such as informed consent, medical visits, administration of a drug or use of a medical device, measurement of clinical parameters, diagnostic testing etc.) can be moved from the research hospital to the patient’s home.
Also in Italy the interest in DCTs is progressively growing, and thanks to their potential benefits DCTs can lead to significant advantages not only for patients, but also for the National Health Service and for the country as a whole. It is important that this interest should act as a stimulus, prompting timely initiatives in order to promote and regulate this new methodology for conduct of clinical trials to avoid the risk that, while other countries will be actively involved in the promotion and leading of DCTs, Italy will be selected only as “control arm”.
Gussoni G. Implementing Decentralized Clinical Trials in Italy: why and how? Multistakeholder expert opinion on priorities for methodology, regulatory affairs, ethics and training. Tendenze Nuove, Special Issue 2/2022 http://www.tendenzenuove.it/2022/07/28/tendenze-nuove-numero-speciale-1-2022-english-version-volume-completo/. Accessed December 2022.
Trials@Home Centre of Excellence Remote Decentralised Clinical. D1.1 First set of recommendations for RDCTs (to be implemented in the pan-EU pilot RDCT) (Version 1 August 2020) https://trialsathome.com/wp-content/uploads/2020/09/Trials@Home_D1.1-First-set-of-recommendations-for-RDCTs-to-be-implemented-in-the-pan-EU-pilot-RDCT.pdf. Accessed December 2022.
Orri M, Lipset CH, Jacobs BP, Costello AJ, Cummings SR. Web-based trial to evaluate the efficacy and safety of tolterodine ER 4 mg in participants with overactive bladder: REMOTE trial. Contemp Clin Trials. 2014;38(2):190-197. https://doi.org/10.1016/j.cct.2014.04.009PMID:24792229 DOI: https://doi.org/10.1016/j.cct.2014.04.009
Gabbrielli F, Zibellini M, Triola R, Bocchino M. Decentralized Clinical Trial: nuovo approccio alla sperimentazione clinica per facilitare il paziente e velocizzare la ricerca. Rapporti ISTISAN 2022| 4IT. https://www.iss.it/documents/20126/6682486/22-4+IT+web.pdf/fe3bab60-295e-88f0-ed58-fa58b2102901?t=1647507337428). Accessed December 2022
Patil B. DCTs deliver big ROI. 2022. https://www.iqvia.com/library/white-papers/dcts-deliver-big-roi. Accessed December 2022.
Accelerating Clinical Trials in the EU (ACT-EU) https://www.ema.europa.eu/en/news/accelerating-clinical-trials-eu-act-eu-better-clinical-trials-address-patients-needs. Accessed January 2023.
Swedish Medical Products Agency. Decentralised clinical trials. 2021. https://www.lakemedelsverket.se/en/permission-approval-and-control/clinical-trials/medicinal-products-for-human-use/decentralised-and-virtual-interventional-clinical-trials. Accessed December 2022.
Danish Medicines Agency. The Danish Medicines Agency’s guidance on the implementation of decentralised elements in clinical trials with medicinal products. (Version 2.0, September 2021) https://laegemiddelstyrelsen.dk/en/news/2021/guidance-on-the-implementation-of-decentralised-elements-in-clinical-trials-with-medicinal-products-is-now-available/~/media/5A96356760ED408CBFA9F85784543B53.ashx. Accessed December 2022.
Swiss Medic - Swiss Ethics. Decentralised clinical trials (DCTs) with medicinal products in Switzerland. (Version 1.0, 09 September 2021) https://swissethics.ch/en/themen/decentralised-clinical-trials-dcts-with-medicinal-products-in-switzerland. Accessed December 2022.
European Commission and European Medicines Agency. Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic – Version 5, 10/02/2022. https://ec.europa.eu/health/system/files/2022-02/guidanceclinicaltrials_covid19_en_1.pdf. Accessed December 2022.
AIFA notice (update of the AIFA notices published on March 12, 2020) – Clinical trials’ management in Italy during the COVID-19 (coronavirus disease 19) emergency (version 2 of 7 April 2020). https://www.aifa.gov.it/documents/20142/871583/Comunicato_gestione_studi_clinici_in_emergenza_COVID-19_EN_07.04.2020.pdf. Accessed December 2022.
Petrini C, Mannelli C, Riva L, Gainotti S, Gussoni G. Decentralized clinical trials (DCTs): a few ethical considerations. Front Public Health. 2022;10:1081150. https://doi.org/10.3389/fpubh.2022.1081150 PMID:36590004 DOI: https://doi.org/10.3389/fpubh.2022.1081150
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Copyright (c) 2023 Elisa Zagarrì, Stefania Frasson, Antonella Valerio, Gualberto Gussoni
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