全球患者和现场解决方案副总裁马克·布朗（Mark Brown）

In 2001, the U.S.National Institute of Health(NIH) mandated that women and members of minority groups must be included in all NIH-funded clinical research, unless developers could make a compelling rationale otherwise. It was a foundational moment in clinical research, requiring the biopharmaceutical industry to acknowledge that diverse studies deliver safer and more effective new drugs.

20年后，赞助商仍在基于治疗率水平以真正代表性的方式招募不同的人群。在批准的新分子实体和生物制剂中2020, just 11 percent of participants were Hispanic, eight percent were Black, and only six percent were Asian.

赞助商发现，组装完全符合所有包容性/排除标准的完全多样化的患者人群并不容易。面对同时降低成本和加速时间表的压力，多样性目标通常可以滑落优先级列表。

However, the growing adoption of decentralized clinical trials (DCTs) may now help make recruiting diverse, representative groups of participants more achievable – without adding significant time and cost to the trial.

Miles to go

研究表明，过度旅行是试验参与的最重要的障碍之一，而服务不足的少数民族社区通常会面临最大的负担。一份2018年的报告发现，虽然审判参与者平均旅行25.8英里为了到达试用地点，来自低收入地区的患者的距离超过两倍 - 富裕参与者的58.3英里比17.8英里。

与该水平的旅行水平相关的时间和成本很快变得站不住脚，导致这些社区的患者到下降入学人数, or to drop-out when the commitment becomes too great. This results in sites limiting their recruiting efforts to patients who live within the local community, which can skew the population to a homogenous demographic.

DCTs eliminate much of this travel burden, by cutting some or all on-site visits from the trial experience. If patients only need to travel to a site a handful of times, the occasional multi-hour trip can feel more reasonable. And if the trial is completely virtual, any patient with internet access can participate from anywhere in a targeted geography – no travel required. This opens recruiting to far-flung communities, and to those who don’t have a car or access to public transportation.

这也意味着站点可以重新考虑其招聘范式，以更多地专注于不同社区的外展，并使用新渠道吸引新患者参加数字患者社区等试验。

However, dealing with travel burden is only the first step. While DCTs dramatically reduce logistical barriers, sponsors and recruiters must address patients’ fears about trial participation, and do more to bolster awareness about trials as a source of care.

无意识的偏见：隐藏的障碍

这National Academy of Sciencesfound that people identifying as black, indigenous, and people of color (BIPOC) are still less likely to receive appropriate medical services, and that they experience a lower quality of health care than whites. This disparity is often the result of unconscious bias among healthcare providers, whotend to display对白人患者的态度更加积极。

这些差异在整个历史上都得到了加强，但是在大流行期间，它们一直是焦点较高的住院和死亡率比19岁的库维德（Covid）比白人社区的社区。

这些令人不安的趋势导致许多BIPOC对临床试验参与持怀疑态度。但是，药物开发人员可以通过真实的外展，教育和透明度来克服这些担忧，以及对患者和社区将如何受益。

这se solutions will require some rethinking of the recruiting and trial process. Initial steps can include:

• 确保调查员团队和审判人员多样化，并代表他们所服务的社区。
• 主持有针对性的患者人口统计学的焦点小组讨论他们的信任问题，并倾听他们过去的偏见经历。这些焦点小组可能是赞助商和招聘人员的学习机会，并使少数民族社区有机会被听到并成为实施积极变化的催化剂。
• 与有色社区的医生和医疗机构合作，以吸引患者并向他们教育临lol买外围用什么软件床试验作为护理选择的好处。与任何人群一样，如果该建议来自他们信任的专业人员，则患者更倾向于考虑参加试验。
• 提供灵活的参与选择，包括远程医疗会议，电子单车和连接的设备，以减少参加试验所需的时间和旅行。lol买外围用什么软件

Worth the effort

当赞助商在他们的试验中包括代表性患者（真正接触受疾病影响的患者）时，可能会导致更有效的治疗方法。这对赞助商，现场和患者有益。

DCT为赞助商提供了克服限制临床试验中多样性的物理障碍的技术。当DCT与更多样化的招聘策略和人员结合使用时，研究将得到充分的态度，以取得更好的结果。