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Screen Failures in Clinical Trials in Retina
Nasiq Hasan1, Kunaal Mehrotra1, Carl J Danzig2
1Department of Ophthalmology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Ophthalmology. Retina
|May 29, 2024
Summary
Screen failures in retinal disease clinical trials are common, often due to imaging and vision criteria. Improving recruitment strategies and eligibility criteria can reduce these failures, enhancing trial diversity.
Area of Science:
- Ophthalmology
- Clinical Trials
- Medical Research
Background:
- Clinical trials for retinal diseases face disparities due to underrepresentation of diverse populations.
- Stringent eligibility criteria and recruitment strategies can hinder trial progress and understanding of retinal diseases.
Purpose of the Study:
- To investigate the reasons for screen failures in retinal disease clinical trials.
- To analyze patient and study characteristics associated with screen failures.
Main Methods:
- A cross-sectional retrospective study analyzing screening data from 87 trials across 6 centers.
- Comparison of study characteristics and patient demographics among different screen failure causes.
- Statistical analysis including descriptive statistics and Pearson chi-square test.
Main Results:
- Over half of the 962 patients screened (51.8%) were screen failures.
- The primary reasons for screen failure were not meeting imaging (44.5%) and vision-based (14.7%) criteria.
- Predominantly White (93.4%) and unemployed/retired (66.6%) patients were screened; non-White representation was low.
Conclusions:
- Imaging and vision criteria are major contributors to screen failures in retinal disease trials.
- Clinical trials predominantly enroll White and unemployed/retired individuals.
- Non-invasive trials show higher patient participation rates than surgical trials, suggesting a need for revised recruitment strategies and eligibility criteria.
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