Craig Reist

Craig Reist, PhD, is a Senior Scientist at RTI with over two decades of experience as a clinical trialist, focusing on metric-driven operational strategies that transform and optimize clinical trials. He has led multiple clinical trials in a variety of therapeutic areas, many of which were pivotal studies for initial drug labeling or label expansion. In his work, Dr. Reist has built collaborative networks with partners across research to enhance the understanding of the disease process with the goal to improve patient care and health outcomes.

Since joining RTI in 2021, Dr. Reist has served on the team for two National Heart, Lung, and Blood Institute (NHLBI)-funded projects, including Researching COVID to Enhance Recovery (RECOVER) and Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS). For RECOVER, he is one of the Principal Investigators for the clinical trials component of the initiative, helping to manage the effort to test therapies for the treatment of Long COVID. He works closely with National Institute of Health (NIH) leadership to oversee the work of the Administrative Coordinating Center at RTI, managing financial and contractual requirements for the program and supporting the RECOVER-CT Steering Committee to ensure effective engagement of all stakeholders. While working on CONNECTS, he helped with the program registry for RECONNECTS, capturing additional data and biospecimens on program study participants as well as establishing an interactive community of study participants. 

Outside of his recent work on RECOVER and CONNECTS, Dr. Reist has worked on clinical trial efforts across a variety of disease types, including studies with patients suffering from kidney disease, heart failure, cardiovascular disease, and more. He has also supported and managed multiple complex research networks and initiatives, helping to provide the necessary oversight to maintain efficient operations and ensure scientific rigor in a multisite research program. In addition, he created a Quality by Design approach using a data surveillance and risk-based monitoring strategy to assess quality within global megatrials. The principles of this approach are now incorporated into The Clinical Trials Transformation Initiative Quality by Design guidance, which contributed to the Federal Drug Administration’s guidelines on Risk Based Monitoring. 

Previously, Dr. Reist worked at 2M Clinical and Duke Clinical Research Institute (DCRI). At DCRI, he directed the DCRI Megatrials Doman, which designs and operationalizes large global commercial clinical trials focused on evaluating new drugs and devices for regulatory approval. During his career, he has led trials with clinical sites in over 50 countries and on 6 continents.