Recruitment has always been a key element to a successful clinical trial, and in the past several years the concept of patient engagement—be­yond getting patients in the door—has grown. Historically for rare and orphan disease trials, engagement has helped recruit patients and make sure they are familiar with the treatments involved in the study, which makes them more willing to utilize the treat­ment once it has been approved.

Patient engagement is not a new concept. Different eClinical tools such as electronic patient-reported out­comes (ePRO) or interactive response technology (IRT) have been in use for some time as a way to get information directly from patients rather than fil­tered through the perspective of inves­tigators. Recently, however, patient ad­vocacy groups and other networks are getting involved in new ways, whether it be by coordinating with sponsors or providing input on protocols, par­ticularly for rare or complex diseases. Advocacy groups are expanding into more areas as well. Where they may have once been reserved for rare con­ditions, there are now many more patient advocacy groups available to provide resources and education to patients in a wide variety of diseases and conditions.

Engagement has become more advanced as it has expanded. Some sponsors are getting patients involved in study design, which connects di­rectly to patients via apps. Tradition­ally, a sponsor company would de­sign the study and set the endpoints without input from patients and with a focus on what doctors considered important. Today, it is more common for sponsors to ask patients: What is important to you in this study? Do the study objectives address your primary concerns? These strategies of early en­gagement can help sponsors provide the most clinically relevant endpoints to both the doctor and the patient, thus increasing the likelihood that a subject will seek to use the product once it is approved.

Patient engagement is key to the re­cruitment of patients for and retention of patients enrolled in clinical trials—but the question of how best to man­age new processes is still ongoing be­cause there are still some unaddressed regulatory concerns.

Written by Guest Writer Kristen Snipes. Snipes has over 18 years of pharmaceutical industry experience primarily as a program manager or clinical operations lead. Since joining Rho in 2007, she has been involved in leading and coordinating all operational activities for complex trials. She has managed analytical method development, formulation, IND filings (including CMC) and phase I-IV clinical trials. She is the Clinical Operations Service Lead for Rho, with responsibilities that include keeping the company current on industry trends and practices as well as supporting training and process development. www.rhoworld.com

This article was reprinted from Volume 23, Issue 11, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>