Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network.

Recruitment and retention are critical in clinical studies but there are limited objective metrics of trial performance. We tested if development of trial performance metrics will allow for objective evaluation of study quality. Performance metrics were developed using data from the observational cohort (OBS) and randomized clinical trial (RCT) arms of the prospective Alcoholic Hepatitis Network. Yield-rate (%YR; eligible/screened), recruitment index (RI; mean recruitment time/patient), completion index (CI; average number of days to complete the follow-up/patient), and protocol adherence index (AI; average number of deviations/subject recruited) were determined. 2250 patients (1168 for OBS; 1082 for RCT) were screened across 8 sites. Recruitment in the RCT (57% target) was similar to that in the OBS (59% target). Of those screened, 743 (63.6%) subjects in the OBS and 147 (13.6%) subjects in the RCT were enrolled in the study. In OBS study, 253 (34.1%) subjects, and in the RCT, 68 (46.3%) subjects, completed the study or reached a censoring event. Across all sites (range), YR for OBS was 63.6% (41.3–98.3%) and for RCT was 13.6% (5.5–92.6%); RI for OBS was 1.66 (8.79–19.85) and for RCT was 4.05 (19.76–36.43); CI for OBS was 4.87 (22.6–118.3) and for RCT was 8.75 (27.27–161.5); and AR for OBS was 0.56 (0.08–1.04) and for RCT was 1.55 (0.39–3.21. Factors related to participants, research design, study team, and research sponsors contributed to lower performance metrics. Objective measures of clinical trial performance allow for strategies to enhance study quality and development of site-specific improvement plans. Trial registration number: ClinicalTrials.gov NCT4072822 NCT 3850899. [Display omitted] • Recruitment, retention and protocol adherence are critical to ensure validity of clinical trials. • There are currently limited objective metrics to evaluate clinical trial performance, especially in multicenter studies. • We developed 4 objective metrics that measure different components of a clinical trial- eligible subjects, those who agree to participate after being eligible, time taken to complete a study visit and protocol adherence rates. • We then tested it in a population of patients with alcohol associated hepatitis who have a high morbidity and mortality. • Objective measures of trial performance allows for identifying challenges including study design, logistics, patient and research team related factors that can be modified to improve study performance. [ABSTRACT FROM AUTHOR]