Methods and Results of Engaging a Participant Advisory Committee for PrecISE

“Methods and Results of Engaging a Participant Advisory Committee for PrecISE” was published in Journal of Allergy and Clinical Immunology in February 2022.

Authors

Dr. Lynn Gerald, Kim Erwin, and Dr. Jerry Krishnan

Abstract

There is relatively little published information about the methods and results of stakeholder engagement in clinical trials to support discovery science (eg, phase 1, 2, or 3 clinical trials). Here, we describe the methods and results of engaging adolescents and adults with severe asthma and their caregivers to inform the design of the PrecISE clinical trial. The PrecISE SC recommended the development of a Participant Advisory Committee (PAC) to solicit feedback among adolescents (and their caregivers) and adults with severe asthma in 5 areas: (1) acceptability of clinical trials among adolescents, their caregivers, and adults with severe asthma; (2) study processes, such as randomizations, placebos, and washouts; (3) study procedures, such as schedules, tests, and incentives; (4) expected participant activities between visits, specifically medication tracking and logging; and (5) proposed treatments, including pathways and blinding. The PAC was coled by 3 PrecISE investigators (Jerry Krishnan, Lynne Gerald, and Rajesh Kumar) and an expert in human-centered design (Kim Erwin).

Full text is at jacionline.org