视网膜临床试验筛选失败。

IF 4.4 Q1 OPHTHALMOLOGY

Ophthalmology. Retina Pub Date : 2024-11-01 DOI:10.1016/j.oret.2024.05.014

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引用次数: 0

摘要

目的：由于某些性别、种族和民族群体的代表性严重不足，临床试验中的差异是一个主要问题。包括严格的资格标准和招募策略在内的一些因素阻碍了我们对视网膜疾病的了解。因此，我们旨在研究筛查失败的各种原因以及筛查失败患者和研究的具体特征：这是一项横断面回顾性研究方法：分析了来自 6 个中心的 87 项试验的筛查数据。比较了导致筛查失败的不同原因的研究特征（研究疾病、试验阶段、给药途径）和患者人口统计学特征（年龄、性别、种族、民族和就业状况）。筛查失败大致分为六类：基于视力的标准导致的排除、成像结果导致的排除、其他因素导致的排除、患者相关标准、医生相关标准和其他。统计分析采用描述性统计、皮尔逊卡方检验和方差分析：确定多项试验中筛查失败的各种原因的发生率及其在不同研究和患者特征中的变化趋势：在87项试验和962名患者中，465名（48.2%）患者被成功随机化，497名（51.8%）患者被归类为筛查失败。这些试验针对各种视网膜疾病。平均年龄为 76.50 ± 10.45 岁，59.4% 为女性。接受筛查的主要是白人（93.4%）和失业/退休患者（66.6%）。在 497 例筛查失败的患者中，大多数是由于患者不符合成像结果的纳入标准（n=221[44.5%]），其次是基于视力的纳入标准（n=73[14.7%]）、其他因素导致的排除（n=75[15.1%]）、与患者相关（n=34[6.8%]）、与医生相关（n=28[5.6%]）和其他原因（n=39[17.8%]）。27（5.4%）名患者未提供筛查失败的原因。与涉及外用药物和光生物调节的非侵入性试验（0%）相比，接受手术试验筛查的患者（15%）拒绝参与研究的比例更高（P=0.02）。白人和失业患者主要参与临床试验。与手术试验相比，患者更愿意继续参与非侵入性临床试验。更好的招募策略和仔细考虑研究标准有助于降低筛查失败率。

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Screen Failures in Clinical Trials in Retina

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.