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■根据美国食品和药物管理局和利益相关者对制药公司关于临床试验多样性的政策指导制定参考标准,并评估这些政策。
■制定临床试验多样性政策的参考标准和结构化审核。
■从2021年市值500强的50家制药公司中选出(25家最大的公司和25家非大型公司,从其余475家公司中随机选择)。
■来自制药公司网站和年度报告的数据。来自美国药物研究和制造商的政策指导,国际制药制造商和协会联合会,生物技术产业组织,国际医学杂志编辑委员会,美国食品和药物管理局,欧洲药品管理局,世界卫生组织,2023年5月15日
■基于来自FDA和利益相关者指南的不同主题的多组分措施。
■审查FDA和利益相关方指南确定了14个不同的主题,建议用于改善临床试验的多样性,纳入参考标准:(1)反映人群中目标条件患病率的入学目标,(2)广泛的审判资格标准,(3)劳动力的多样性,(4)确定和纠正审判招聘和保留的障碍,(5)将患者输入纳入试验设计,(6)健康素养,(7)多样性的多维方法,(8)具有不同提供者和患者群体的网站,(9)产品批准后的数据收集,(10)在进行试验的每个国家/地区都有不同的入学率,(11)多样化的招生应该是临床试验所有阶段的重点,不仅仅是后期阶段或关键试验,(12)各种试验设计,(13)扩展访问,(14)公开报告试验参与者的个人特征。应用此参考标准,48%(24/50)的公司没有关于临床试验多样性的公共政策;在有政策的公司中,内容差异很大。大型公司比非大型公司更有可能制定公共政策(21/25,84%v5/25,20%,P<0.001)。大型公司最经常致力于使用基于流行病学的试验注册目标,代表不同人群中指定条件的患病率(n=15,71%)。应对审判招募的障碍(n=15,71%),并提高患者对试验机会的认识(n=14,67%)。公司的位置与公共多样性政策无关(P=0.17)。平均公司政策在14项承诺中有5项(36%,范围0-8)在FDA和利益相关者指南中推荐。
■研究结果表明,许多制药公司在临床试验中没有关于多样性的公共政策,虽然政策在大型公司比非大型公司更常见。公开可用的政策差异很大,缺乏利益攸关方指导建议的重要承诺。研究结果表明,可以更好地利用企业政策促进研究中的代表性和公平包容,以及实施FDA和利益相关者指南。
UNASSIGNED: UNASSIGNED: To develop a reference standard based on US Food and Drug Administration and stakeholder guidance for pharmaceutical companies\' policies on diversity in clinical trials and to assess these policies.
UNASSIGNED: Development of a reference standard and structured audit for clinical trial diversity policies.
UNASSIGNED: 50 pharmaceutical companies selected from the top 500 by their market capitalizations in 2021 (the 25 largest companies and 25 non-large companies, randomly selected from the remaining 475 companies).
UNASSIGNED: Data from pharmaceutical company websites and annual reports. Policy guidance from the Pharmaceutical Research and Manufacturers of America, International Federation of Pharmaceutical Manufacturers and Associations, Biotechnology Industry Organization, International Committee of Medical Journal Editors, the US Food and Drug Administration, European Medicines Agency, and World Health Organization, up to 15 May 2023.
UNASSIGNED: Multicomponent measure based on distinct themes derived from FDA and stakeholder guidance.
UNASSIGNED: Reviewing FDA and stakeholder guidance identified 14 distinct themes recommended for improving diversity in clinical trials, which were built into a reference standard: (1) enrollment targets that reflect the prevalence of targeted conditions in populations, (2) broad eligibility criteria for trials, (3) diversity in the workforce, (4) identification and remedy of barriers to trial recruitment and retention, (5) incorporation of patient input into trial design, (6) health literacy, (7) multidimensional approaches to diversity, (8) sites with diverse providers and patient populations, (9) data collection after product approval, (10) diverse enrollment in every country where trials are conducted, (11) diverse enrollment should be a focus for all phases of clinical trials, not just later stage or pivotal trials, (12) varied trial design, (13) expanded access, and (14) public reporting of the personal characteristics of participants in trials. Applying this reference standard, 48% (24/50) of companies had no public policy on diversity in clinical trials; among those with policies, content varied widely. Large companies were more likely to have a public policy than non-large companies (21/25, 84% v 5/25, 20%, P<0.001). Large companies most frequently committed to using epidemiological based trial enrollment targets representing the prevalence of indicated conditions in various populations (n=15, 71%), dealing with barriers to trial recruitment (n=15, 71%), and improving patient awareness of trial opportunities (n=14, 67%). The location of the company was not associated with having a public diversity policy (P=0.17). The average company policy had five of the 14 commitments (36%, range 0-8) recommended in FDA and stakeholder guidance.
UNASSIGNED: The findings of the study showed that many pharmaceutical companies did not have public policies on diversity in clinical trials, although policies were more common in large than non-large companies. Policies that were publicly available varied widely and lacked important commitments recommended by stakeholder guidance. The results of the study suggest that corporate policies can be better leveraged to promote representation and fair inclusion in research, and implementation of FDA and stakeholder guidance.