Decentralized Clinical Trials - Need, Challenges and Prospects

Clinical trials, as currently conducted, are expensive, inefficient, and inaccessible. Furthermore, they fail to represent the patient population adequately. Currently, clinical trials are conducted centrally (at one trial site), at multiple individual trial sites, and/or remotely (via digital health technologies), depending on the type of data needed. Decentralized trials or Virtual clinical trials (VCT) can increase participant access and geographic representation, improve participant experience, and enhance recruitment of patient subpopulations. While decentralized trial is not new to the Pharma companies and CROs, the industry saw a surge in the adoption of decentralized clinical trials during COVID-19 times. This model allowed pharma companies to continue their clinical trials while keeping patients safe and out of clinical site. As the pandemic winds down, most researchers expect the decentralized model to be the new norm going forward. Study patients are being monitored from their homes and does that creates challenges for sponsor companies to track that data? What are the challenges of transitioning to hybrid, decentralized trial model, that companies need to overcome to succeed. This article identifies the challenges faced by the industry-in terms of technology, regulations and patient engagement adapting to the decentralized trials and the potential prospects to overcome the same.