Incorporating virtual features into clinical trials: a review of current evidence of decentralised clinical trials to summarise design considerations for conducting a “hybrid” clinical trial

Abstract

Background: The COVID-19 pandemic has heightened interest in decentralised or virtual clinical trials. The MEL-SELF trial that aims to compare patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma, involves a “hybrid” design of a randomised controlled trial, with features of both conventional and virtual trials.

Aims: We aimed to undertake an evidence review of published clinical trials using decentralised or virtual approaches to inform optimal “hybrid” design for the MEL-SELF trial. 

Methods: We searched English language reports in MEDLINE and EMBASE databases using MESH words: “pragmatic clinical trial”, “adaptive clinical trial” and “internet-based intervention” and text words. Two reviewers will undertake full text assessment and data extraction, and we will undertake a narrative synthesis of findings. 

Results: Our database searches retrieved 3446 titles and abstracts. Preliminary findings include breadth of geographical location (including Canada, Switzerland, the UK, and the USA) and health conditions (including COVID-19, low back pain, Parkinson's disease, autism spectrum disorder and overactive bladder). Prominent features of the trial design were the use of web-based trial processes and outcome measurement (screening, recruitment, consent, randomisation, reminders, diaries, questionnaires and other direct data capture). Other features included the use of interactive video instruction about participant activities, an active run-in phase, and mailing study instruments and/or interventions directly to participants. Final results will be presented at the conference.

Conclusions: The findings from this evidence review will yield insights into key pragmatic virtual features important for the design of hybrid trials.