Considerations For Implementing Decentralized Clinical Trials

By Marina Acosta Enslen, Associate Director, Clinical Management

The COVID-19 pandemic has accelerated the implementation of decentralized (also referred to as virtual, remote, or hybrid) solutions for clinical trials. In addition to keeping your clinical trials on-track during the pandemic, decentralized solutions can often provide the following added benefits:

1) An improved patient experience (i.e. reduced burden and increased engagement)
2) Lower barriers to patient recruitment
3) Increased patient retention and lower drop-out rates
4) Higher data quality

Our teams have helped many sponsors navigate and implement decentralized solutions for their clinical trials and programs. This includes providing recommendations for the level of decentralization required (e.g. a fully virtual trial or a hybrid approach), as well as the development of strategic plans for remote and central monitoring, technology integration, IP management, and site and patient engagement.

Based on our experience, we believe that the best decentralized solutions are patient-centric, customized, and rooted in a robust Risk-Based Quality Management (RBQM) framework, as specified by the E6R2 guidance.

Below we will discuss some considerations for successfully implementing decentralized solutions: