Remote decentralized clinical trials: a new opportunity for laboratory medicine

Federico Pennestrì; Giuseppe Banfi; Rossella Tomaiuolo

doi:10.1515/cclm-2022-1184

Article

Remote decentralized clinical trials: a new opportunity for laboratory medicine

Federico Pennestrì , Giuseppe Banfi and Rossella Tomaiuolo

Published/Copyright: January 5, 2023

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 8

Abstract

The traditional venue of clinical trials has been hospitals or specialized research units, usually requiring participants to come on-site. Although their contribution to biomedical progress is beyond dispute, they are characterised by two crucial logistical and ultimately scientifical limitations: poor retention and poor generalizability of results, as patients often have problems in concluding the investigation on-site. Remote Decentralised Clinical Trials (RDCTs) take advantage of digital technologies to design trial activities closer to the home of participants, with the aims of minimizing travel to health facilities and the risk of infections, improving the quality of life of participants and caregivers, reducing work absenteeism, including broader cohorts of patients and possibly reducing costs. RDCTs represent a minority of current global research, but the Covid-19 pandemic brought them to the fore. The authors of this paper promote the spread of RDCTs, building on early recommendations from international institutions, and provide some examples of their use and potential benefits in laboratory medicine.

Keywords: decentralized clinical trials; digital medicine; patient-reported outcomes; remote clinical trials; telemedicine; value-based care

Corresponding author: Federico Pennestrì, PhD, IRCCS Istituto Ortopedico Galeazzi, Via Cristina Belgioioso 173, 20157 Milan, Italy, Phone: +39-02-83502224, E-mail: federico.pennestri@grupposandonato.it

Funding source: Ministero della Salute

Research funding: This paper was supported and funded by the Italian Ministry of Health — “Ricerca Corrente”. The funding organization played no role in the study design, in the collection, analysis, and interpretation of data; in the writing of the report or in the decision to submit the report for publication.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

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Received: 2022-11-20

Accepted: 2022-12-21

Published Online: 2023-01-05

Published in Print: 2023-07-26

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Articles in the same Issue

https://doi.org/10.1515/cclm-2022-1184

Keywords for this article

decentralized clinical trials; digital medicine; patient-reported outcomes; remote clinical trials; telemedicine; value-based care