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Frost & Sullivan presents post–COVID-19 growth opportunities and strategic imperatives for the global decentralized clinical trials (DCT) market, covering the market’s maturity, key participants, adoption drivers and restraints, and recent mergers and acquisitions. The report identifies initiatives by major global contract research organizations (CROs) toward DCT adoption; estimates growth patterns for the next 5 years based on detailed analyses of drug and biologics interventional trials, COVID-19–triggered adoption of DCT by sponsors and CROs to continue the disrupted trial operations; and the expected cost-benefit associated with the reduction in site-management burden. The analysis includes regional drivers and challenges of adoption based on select socio-economic and industry parameters.

The DCT market was in a nascent stage prior to the COVID-19 pandemic. The accelerated adoption witnessed during the pandemic outbreak in 2020 was mainly due to restricted mobility of site investigators, clinical research associates, and patients to participate in the trials. To ensure patient safety, most sponsors and CROs adopted digital tools to support trial operations that included telemedicine, remote source data verification, and sensor/mobile technology-enabled direct data-capture solutions. Recent initiatives conducted by the Decentralized Trials & Research Alliance have increased awareness of DCTs globally and catapulted their adoption, especially in North America. The evolving regulations supporting the ease of implementing technologies that enable DCT delivery in Europe and other regions will drive adoption.

However, adoption of decentralized trials is challenged by concerns about data privacy, scalability, and seamless implementation across different continents. Need has increased to support decentralized trials through cloud-based platform solutions that are fit to purpose. CROs building decentralized trial capabilities are partnering with technology vendors to overcome these challenges. Online training modules for patients and secure technology for at-home trial monitoring through devices and sensors have been driving the adoption of decentralized trials after the pandemic. Home health services patients with physical disabilities and restricted access due to location can promote retention in clinical trials. Partnering with home health service providers supported by nurses trained in use of portable equipment will facilitate smooth DCT implementation. Additionally, CROs are focused on innovating trial enrollment and patient engagement strategies by exploring multiple channels, such as use of advocacy groups, social media, and online physician referral systems.