Cerevel Therapeutics, Cambridge, MA, USA.
Cerevel Therapeutics, Cambridge, MA, USA.
Contemp Clin Trials. 2023 Mar;126:107092. doi: 10.1016/j.cct.2023.107092. Epub 2023 Jan 23.
Considering diversity, equity, and inclusion (DEI) in clinical trials ensures that data collected for investigational treatments reflect the populations most likely to benefit from those therapies. Resources and recommendations regarding DEI were assembled by the trial sponsor to assist clinical trial development.
A cross-disciplinary team from the sponsoring organization was assembled to inform trial planning and collate resources that promote DEI throughout the clinical trial life cycle.
Representatives from clinical operations, health economic outcomes research, medical affairs, patient advocacy, procurement, and research and development functional groups united together to implement DEI strategies in clinical trials. Planning strategies focus on eligibility, participant/patient engagement, feedback through patient advocacy organizations, and community interactions. Informed site, investigator, and vendor selection at trial startup supports efforts to recruit diverse target trial populations and engage underrepresented businesses; establishing relationships and demographic target-goal tracking should be maintained throughout trial management. Continued communication during trial closeout consolidates learnings and enhances partnerships with trial participants and patient advocacy organizations. The sponsoring organization continuously updates an internal library of resources to facilitate implementation of outlined strategies.
This first iteration of guidance intends to improve the representation of target populations who will ultimately benefit from investigational therapies; to assist sponsor clinical trial teams in developing recruitment and retention plans; and to ensure compliance with federal granting agencies. The sponsoring organization anticipates data from future clinical trials will help characterize the impact of these initiatives to ensure evidence-based practices are used in future clinical trials to enhance DEI.
在临床试验中考虑多样性、公平性和包容性（DEI）可确保为研究性治疗收集的数据反映最有可能从中受益的人群。试验赞助商收集了有关 DEI 的资源和建议，以协助临床试验的开展。
由赞助组织的跨学科团队成立，为试验规划提供信息，并整理在整个临床试验生命周期中促进 DEI 的资源。
来自临床运营、健康经济结果研究、医学事务、患者宣传、采购以及研发功能组的代表共同努力，将 DEI 策略纳入临床试验。规划策略侧重于资格、参与者/患者参与、通过患者宣传组织提供反馈，以及社区互动。在试验启动时进行知情的站点、研究者和供应商选择，支持招募多样化的目标试验人群和吸引代表性不足的企业；在试验管理过程中应建立关系并跟踪人口统计目标。在试验结束时持续沟通可总结经验教训并加强与试验参与者和患者宣传组织的合作。赞助组织不断更新内部资源库，以促进实施既定策略。
本指南的首次迭代旨在提高最终将从研究性治疗中受益的目标人群的代表性；协助赞助商临床试验团队制定招募和保留计划；并确保符合联邦资助机构的要求。赞助组织预计未来临床试验的数据将有助于描述这些举措的影响，以确保在未来的临床试验中使用基于证据的实践，从而增强 DEI。
