Background A direct-to-family or virtual approach can improve participant recruitment, retention, and diversity, and improve efficiency of clinical trials. Pediatrics and rare disease may especially benefit from this approach. Recruitment and enrollment of direct-to-family trials in pediatric lupus has not been described. We hypothesize that engaging patients and leveraging a disease registry will facilitate recruitment and enrollment into a direct-to-family pediatric lupus trial (NCT: 04358302).
Objective Evaluate the feasibility of enrolling and recruiting participants into a nationwide, novel direct-to-family pediatric lupus trial
Methods Investigators and study leaders collaborated with patients and advocacy groups, key stakeholders, and a disease registry (Childhood Arthritis and Rheumatology Research Alliance, CARRA Registry) to design a direct-to-family pediatric lupus trial. Participants across the country were identified through the CARRA Registry. Recruitment and informed consent/assent were conducted remotely by a single site (Duke Clinical Research Institute, DCRI).
Results 191 potentially eligible participants were identified through the CARRA Registry. Of the 84 participants who participated in a live discussion, 44 (52%) scheduled a consenting call. The original enrollment goal of 20 participants was met in 10 days. Enrollment was increased to 26, and an additional 18 participants were added to a back-up list due to high interest.
Conclusions Using a single site to recruit and enroll participants into a nationwide direct-to-family pediatric lupus trial was highly feasible, quick, and effective. Recruiting participants from a disease registry and engaging patient advocacy groups were key to successful enrollment.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.