Decentralized clinical trials (DCTs) are playing a role in an increasing number of drug and biologics development programs. While these types of trials are fairly new, the COVID-19 pandemic has accelerated industry interest in realizing the numerous benefits that a DCT can offer. To date, DCT implementation has outpaced the changes needed in some important areas that typically inform clinical trials design and execution, including regulatory guidance, trial design and execution considerations, trial monitoring and management, and comprehensive data quality management.

As a Clinical Research Organization working with numerous cutting edge biotech and small pharmaceutical companies, Rho has been engaged in overcoming the many regulatory, design, and implementation hurdles that these trials can present. While much has been written about the potential benefits that these trials can bring, our experience in this space has taught us that there are several questions that sponsors should be asking as they consider the end-to-end execution of a DCT. Failure to consider and address many of these questions may limit the benefits these trials can yield, and can introduce numerous risks to data integrity.

In a series of five blog articles, Rho experts will outline several topics and key questions to ask when considering (and/or designing) a DCT. In this series, we will cover:

• The foundational aspects of DCTs, including terminology, benefits, risks, and technologies;
• The current US regulatory landscape;
• Protocol planning and design considerations;
• Data collection, monitoring, handling, quality control, and management processes; and
• Inspection and audit preparation.

In these articles, we will provide references to available guidance, select articles, and mapping documents.

Rob Woolson, MS, JD, Chief Strategist, Biostatistics & Standards for Regulatory Submissions, has 18 years of experience as an applied statistician. Mr. Woolson brings an extensive background of statistical and project leadership experience on US and ex-US regulatory submissions, having led the biostatistical and technical aspects of 12 CDISC-compliant marketing applications, having guided the creation of ISS/ISE statistical analysis plans; integrated analysis dataset design and production; integrated display design and production; and submission-related documentation development. He has conducted statistical analyses in all phases of drug development (Phase I through IV, NDAs, and BLAs) and has led SDTM/ADaM dataset conversion projects in multiple therapeutic areas. Rob works extensively as a consultant advising sponsors on integrated statistical analysis planning, integrated database design, regulatory data submission requirements, and CDISC standards application and implementation. He has authored responses to numerous FDA queries and has represented sponsors at numerous FDA face-to-face meetings, including Advisory Committee meetings. Mr. Woolson’s educational background includes a Bachelor’s degree in mathematics from Northwestern University, a Juris Doctor degree from DePaul University, and a Master’s degree in applied statistics from DePaul University.