Related Experiment Videos
Clinical trial performance of community- vs university-based practices in the submacular surgery trials (SST): SST
Neil M Bressler1, Barbara S Hawkins, Susan B Bressler
1Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD 21205-2005, USA. nmboffice@jhmi.edu
Objective:
To compare the performance of community- vs university-based clinical centers in 3 multicenter randomized clinical trials of intraocular surgery.
Methods:
Each Submacular Surgery Trials clinical center was classified as a university-based center, if the contract to perform as a center was signed by a university official, or as a community-based center. The 2 groups of centers were compared on performance, assessed cumulatively by the Submacular Surgery Trials Quality Assurance and Monitoring Subcommittee.
Outcome Measures:
Patient accrual, completion of scheduled examinations, completion of masked vision examinations 2 years after enrollment (the designated primary study end point evaluation time), timeliness of submission of retinal photographs required by protocol to the Photograph Reading Center, completion of health- and vision-related quality-of-life interviews, and timeliness of submission of the primary outcome data to the Coordinating Center after completion of the examination.
Results:
Almost all centers performed at a very high (good) level, although there was a trend for some community-based centers to be at the lower end of most distributions.
Conclusions:
Most community- and university-based centers performed well in these multicenter clinical trials. Monitoring performance and periodically providing feedback to clinical center investigators may encourage excellent performance in areas critical to the success of clinical trials, regardless of whether the center is community or university based.
