B45-25 Clinical Trial Recruitment in the US Bronchiectasis and NTM Research Registry and the Future Clinical Trials Network

Rationale Recruitment into bronchiectasis and nontuberculous mycobacterial (NTM) clinical trials is challenged by underdiagnosis, limited disease awareness, heterogeneous patient populations, strict eligibility criteria, high treatment burden, and the geographic dispersion of small patient pools. These barriers are compounded by competition in simultaneously enrolling trials. The US Bronchiectasis and NTM Research Registry (BRR) was established in 2008 to serve as a centralized database of bronchiectasis and NTM patients. While historically utilized for investigator-initiated projects, the BRR also serves as a resource for clinical trial recruitment. The BRR is therefore the foundation for a Clinical Trials Network (CTN) in formulation, which we hypothesize will help to reduce some of the barriers to clinical trial recruitment. Methods The BRR is a physician-reported database collecting detailed demographic, clinical, microbiologic, imaging, treatment, and symptom data abstracted from electronic medical records at enrollment and annually thereafter. For clinical trial recruitment collaborations, BRR research leadership and industry partners review and align study inclusion and exclusion criteria with available registry data. Using these criteria, the BRR team identifies potentially eligible patients and communicates this information to participating sites, which then confirm eligibility status (eligible, ineligible with reason, or pending eligibility). Once established, eligibility lists are updated every quarter for the duration of the trial. Results Since January 2023, three industry partners have utilized the BRR for clinical trial recruitment (designated as Trials A, B, and C). Two of the three trials targeted NTM lung disease, and one focused on bronchiectasis.At the time of the initial quarterly data pull for Trial A, 5,346 BRR participants had available data for screening. Applying the agreed-upon inclusion and exclusion criteria identified 245 (4.6%) potentially eligible patients, representing 63% (15/24) of BRR sites. Of these 15 sites, 7 were active participants in Trial A, collectively accounting for 157 of the 245 identified patients. Among those 157 patients, 47 (30%) were confirmed as eligible or pending eligibility. Comparable outcomes were observed for Trials B and C (see Table 1). Conclusions Our data demonstrate the BRR is a valuable resource for facilitating clinical trial recruitment by efficiently identifying both eligible patients and high-performing sites for participation. As the BRR transitions into a formal CTN, its infrastructure will further support end-to-end trial operations, including site feasibility assessments, protocol review and optimization, targeted recruitment strategies, and streamlined contracting processes. These capabilities position the CTN as a central platform for accelerating multi-center, clinical research in bronchiectasis and NTM lung disease. This abstract is funded by: Bronchiectasis and NTM Association