By Paul Richardson, Senior Director, Consulting, THREAD
A 2020 study outlined how using decentralized clinical trial (DCT) design outperforms traditional trials in patient recruitment and retention. The findings highlight the inherent adaptability of a decentralized approach; DCT can pivot more quickly to take advantage of opportunities or mitigate challenges that affect clinical research.
When evaluating how to maximize trial success, especially given the growth of DCT methodology, scaling studies on a global level provides significant opportunity to enhance health outcomes and improve study timelines in the life sciences industry. Scaling clinical research should not just focus on increased usability throughout geographies nor should it only consider scaling existing solutions, no matter how successful those might be. Scaling a DCT depends on innovation in design, operational excellence, and leveraging ideas that result in better outcomes. Successfully scaling a virtual trial also means pre- and post-evaluation at every step in the process.
Enhancing Sponsor and CRO Trial Efficiencies
Sponsors and CROs can enhance their efficiencies through DCT-inherent efficiency which can then be maximized through a strategic approach to scaling trials on a global level. Cost savings associated with hybrid clinical studies result from both the ability to quickly scale studies and DCT systems that allow for the setup of a study-specific single platform. Fiscal benefits also result from adherence to global operations from the sponsors, CROs and clinical teams involved in executing the DCT. Ensuring standard operating procedures, ongoing KPI alignment, full team buy in and key learning sharing across networks also enhance the benefits of a decentralized approach.
Decentralized Clinical Trial Phases Defined
Reaping these benefits requires a defined process to scale DCTs through a phased approach that supports change management throughout the research organization:
DCT Phase 1: Initiate
Identify Next Studies
Confirm Initial KPIs
Assign DCT Super Users
Develop Global Library
DCT Phase 2: Scale
Train Organization Broadly
Confirm Final KPIs
Develop Initial SOP & Processes
Design DCT Experience Matrix
DCT Phase 3: Mature
The best way to execute research is through a scalable and configurable DCT platform. It’s also critical that every study is supported by hybrid and decentralized trial experts that understand your objectives, trial needs, and innovative solutions to your unique challenges Contact THREAD to learn how to scale your DCT and ensure your trial is successful.