There have been a series of deficiencies created by traditional trials that have been historically documented. Some of these deficiencies include recruitment and enrollment challenges, difficulties to retain trial participants, lack of inclusion and diversity, and problems connected to data quality and integrity. Disrupting traditional clinical research with decentralized clinical trials (DCTs) is a multi-dimensional and multi-functional enterprise that requires expertise from the scientific, medical, clinical research, operational, regulatory, legal, quality control, and quality assurance areas working in unison to design and deliver fit-for-purpose, customized solutions. Strategically and operationally, there are a series of DCT components that are selectively deployed in DCTs, including:
- The initial design and optimization of trial protocols to make them suitable for DCT solutions;
- Use of a digital platform with integration, multifunctionality, and interoperability capabilities to support DCT related activities such as telehealth visits, e-Consent, and e-Signature processes, and administering e-clinical outcome assessments;
- Selection of the appropriate digital wearable devices and their corresponding digital endpoints to holistically measure specific health outcomes;
- Selection of DCT proficient sites;
- Direct-to-participant shipment of an experimental medical product when feasible and medical supplies;
- Use of participant recruitment services to bolster enrollment;
- Defining meaningful concierge services that will support participant-centric approaches;
- And implementing in-home health services such as nursing services that are needed to support remote visits.
The combination of these DCT components following the scientific rigor, operational feasibility, and regulatory and legal frameworks makes it possible to assess the safety and efficacy of novel medical products in a more efficient manner, delivering quality results for regulatory approval and imminent commercialization for the benefit of many people who are in need of these novel products. This presentation discussed ICON’s philosophy and experience in disrupting clinical research with our DCT strategies and the DCT components described.
Isaac R. Rodriguez-Chavez, PhD, MHSc, MSc
Senior Vice President, Scientific and Clinical Affairs; Head, Decentralized Clinical Trials and Digital Medicine Strategy, ICON plc.
Executive Director, DCT Strategic Operations, ICON plc.