On October 29, 2018, Berry Consultants proudly released the first in a series of short videos undertaken in our role as the Innovative Clinical Trials Resource (ICTR) for the National Institute of Health's National Heart, Lung, and Blood Institute (NHLBI). Our own Dr. Anna McGlothlin presented an engaging overview of the rationale and considerations related to single arm clinical trials.
Single arm studies are used to conserve resources and facilitate enrollment, particularly in rare diseases, where the available number of participants is limited. Potential participants, often reticent to be assigned placebo, are more likely to enroll when guaranteed access to a novel therapy. Without a control, single arm trials immediately save 50% of the required patient resources compared to a standard randomized controlled trial. While simple in concept, single arm trials pose challenges in interpretation and generalization, particularly due the uncertainty about how the control arm might have behaved. In this short video Dr. Anna McGlothlin discusses these trade-offs and introduce possible innovative alternatives to single arm studies, such as statistical borrowing of historical information in a randomized study.
You may view the video here. We encourage readers to access all of the resources available on the ICTR website, available at https://innovativeclinicaltrial.org and to register for an account to receive alerts when new materials are listed. We also welcome comments and questions and may use these in future blogs posts!