Decentralized Clinical Trials – Current Environment, Potential Barriers and Facilitators for Implementation and Risk Mitigation: A Review of the Literature

Abstract

Abstract Introduction Decentralized clinical trials are a new approach in health technology research and development that take advantage of innovative digital technologies in data collection for clinical trial purposes. Decentralized clinical trials achieve shorter participant recruitment periods, better adherence to assigned therapy, lower drop-out rates and shorter trial duration overall. Participants reported greater convenience compared to traditional clinical trials due to the studies being conducted at home and the removal of transport and time barriers. Materials and methods A literature review was conducted using the Scoping Review methodology defined by Arskey and O’Malley in 2005 and further updated in 2010 and 2014. PubMed, Scopus, and Google Scholar scientific databases were searched using predefined inclusion and exclusion criteria and keywords: virtual clinical trials, and/or decentralized clinical trials and barriers and challenges. Results The literature review found 40 articles that met the specified inclusion and exclusion criteria. The results of the different studies in this area show that decentralized clinical trials achieve shorter recruitment periods, better adherence to assigned therapy, lower dropout rates from trials, and shorter trial duration overall. Participants reported greater convenience compared to traditional clinical trials due to the studies being conducted at home and the removal of transport and time barriers. Major challenges with this type of trial is the difficulty in conducting physical examinations, invasive therapies by the investigators, and privacy protection. Conclusion The adoption of a regulatory framework for digital healthcare, education of medical professionals and patients about innovative technologies are necessary, especially in countries from Central and Eastern Europe.