Decentralised Clinical Trials: Achieving our Ambition?
Decentralised Clinical Trials (DCTs) present a biopharmaceutical company with a series of opportunities and challenges. We highlight the challenges and examine the value the individual DCT elements may create for patients, investigators and site staff, regulators and ethics committees, and the sponsor. We also contend that for a DCT to be truly patient-centric, the patient must be provided with flexible, pragmatic options when taking part in a clinical study. Our research suggests that there are elements of DCT that are yet to evolve, with less than 0.1% of ongoing industry-sponsored interventional studies including a wearable or biosensor. Finally, we lay out an operating model framework and set of critical success factors to support a biopharmaceutical company in its enablement of DCTs.
- Published April 2023 -