Related Experiment Video
Updated: Jul 5, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the
Srinivasan Dasarathy1, Wanzhu Tu2, Annette Bellar1
1Department of Gastroenterology & Hepatology and Inflammation and Immunity, Cleveland Clinic, Cleveland, OH, United States of America.
Background:
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.
Methods:
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.
Results:
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.
Conclusions:
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 NCT03850899.
More Related Videos
07:02A Computerized Test Battery to Study Pharmacodynamic Effects on the Central Nervous System of Cholinergic Drugs in Early Phase Drug Development
Published on: February 11, 2019
06:32Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
Published on: July 14, 2023
