Xtalks Spotlight: How are Decentralization Practices Changing CNS Clinical Trials?

The adoption of decentralized clinical trial models has gained significant momentum in the past several years, even before the COVID-19 pandemic that triggered the need for more remote options to mitigate trial disruptions. Remote trial monitoring and assessments offer significant benefits to patients and investigators alike and are thus becoming a mainstay option in clinical studies.

In this Xtalks Spotlight feature, Xtalks spoke with Rachel Colite, Vice President of Decentralized Clinical Trials at Cogstate, who shared trends, considerations and benefits of remote and decentralized clinical trial implementation. She provided practical examples of the applications of remote trial options, particularly for central nervous system (CNS) clinical trials.

Decentralized trial practices can improve enrollment, retention, study timelines and participant diversity. It is estimated that 70 percent of potential participants live more than two hours from a study center, creating challenges for meeting enrollment goals, study timelines and compounding issues around diversity in clinical trial participation.

Remote trial monitoring in decentralized clinical trials relies on the use of technologies designed to measure, analyze and transmit data to investigators. This lends power to trial monitoring, wherein data can be collected more frequently and in real time with the use of health wearables with biosensors and other measurement devices. These devices should have user-friendly designs to facilitate accurate measurement and data collection processes.

The appropriate administration of clinical outcomes assessments (COAs) is critical to the collection of study endpoint data in trials. When implemented well, remote administration of COAs in decentralized clinical trial models brings clear benefits to trial conduct. These include minimizing data loss, collecting data more frequently and reducing patient burden through improved accessibility with time and cost savings. There are also numerous advantages for study sponsors as remote assessments using electronic means of data collection can free up resources at study sites, reduce errors, allow for faster data collection and offer rapid analytics for a quicker decision-making process.

However, remote COA administration presents both unique challenges and important opportunities related to suitability and validity for remote conduct and practical implementation. This includes a potentially greater reliance on patient-reported outcome (PRO) measures, which have limitations and can pose to be a caveat with respect to data integrity.

In working with sponsors, license holders, technology partners and regulators, Cogstate says its team has gained important perspectives on the successful implementation of remote COA administration in decentralized clinical trials.

Gain more insights into the unique opportunities of remote COA administration in decentralized clinical trials in this Xtalks Spotlight discussion with Rachel Colite.