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How to Scale Successful Decentralized Clinical Trials

Cassidi Williams

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

  • Standardize Design Process
  • Repeatable Integrations
  • Final SOP & Processes
  • Experience Matrix & Publication

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.

Paul Richardson
Senior Director, Consulting, THREAD

Paul Richardson is a Senior Director Consulting at THREAD. Paul’s role is to ensure customers are successful in the strategic design and deployment of technologies throughout the course of their clinical trials. Paul's career includes nearly 20 years of leading companies, product development, global operations, design and adoption of technology in the most difficult of sectors: healthcare and drug development.