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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.
Purpose:
Disparities in clinical trials are a major problem because of significant underrepresentation of certain gender, racial, and ethnic groups. Several factors including stringent eligibility criteria and recruitment strategies hinder our understanding of retinal disease. Thus, we aimed to study the various reasons of screen failures and specific patient and study characteristics among screen failures.
Design:
This is a cross-sectional retrospective study.
Methods:
Screening data of 87 trials from 6 centers were analyzed. Study characteristics (disease studied, phase of trial, and route of drug administration) and patient demographics (age, gender, race, ethnicity, and employment status) were compared among different causes of screen failures. Screen failures were broadly classified into 6 categories: exclusion because of vision-based criteria, exclusion because of imaging findings, exclusion because of other factors, patient-related criteria, physician-related criteria, and miscellaneous. Descriptive statistics, Pearson chi-square test, and analysis of variance were used for statistical analysis.
Main Outcome Measures:
Prevalence of various reasons for screen failures in multiple trials and its trend among different study and patient characteristics.
Results:
Among 87 trials and 962 patients, 465 (48.2%) patients were successfully randomized and 497 (51.8%) patients were classified as screen failures. The trials were conducted for various retinal diseases. Mean age was 76.50 ± 10.45 years and 59.4% were females. Predominantly White patients (93.4%) and unemployed/retired patients (66.6%) were screened. Of the 497 screen failures, most were because of patients not meeting inclusion criteria of imaging findings (n = 221 [44.5%]) followed by inclusion of vision-based criteria (n = 73 [14.7%]), exclusion because of other factors (n = 75 [15.1%]), patient-related (n = 34 [6.8%]), physician-related (n = 28 [5.6%]), and miscellaneous reasons (n = 39 [7.8%]). Reason for screen failure was not available for 27 (5.4%) patients. A higher proportion of patients screened for surgical trials (15%) declined to participate in the study compared with noninvasive trials involving topical drugs and photobiomodulation (0%) (P = 0.02).
Conclusions:
Patients not meeting the imaging and vision-cased criteria were the most common reasons for screen failures. White patients and unemployed patients predominantly participated in clinical trials. Patients are more inclined to continue participation in noninvasive clinical trials compared with surgical trials. Better recruitment strategies and careful consideration of study criteria can aid in decreasing the rate of screen failures.
Financial Disclosure(S):
Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.
Insights
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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