5.18.23
The COVID‑19 pandemic highlighted long‑standing and vast inequities in the US healthcare system. 作为打击这种不公正的关键一步, organizations must strive for equitable representation in their clinical trials.
这是美国历史上第一次, clinical trial coordinators must adhere to a statutory requirement for increased diversity in their trials’ patient panels. 由拜登总统于2022年12月签署, 《综合拨款法案, 2023 (Public Law 117-328) requires diversity action plans for clinical trials, providing a long-needed framework to generate clinical trial participation that is representative of the population.
The law directs organizations to increase access to and the diversity of their clinical trials. 在临床试验中有更好的代表性, it is important to understand the relationship between underrepresented populations and the history of clinical trials in the US, along with the current barriers that exist across the clinical trials enrollment process. 从那里, organizations can develop sustainable strategies to ensure their clinical trials are truly representative of the populations they serve.
建立信任，克服过去
Clinical trials provide access to novel medical treatments and innovative care for patients seeking specialized medical services for conditions ranging from chronic illnesses, 如糖尿病, 最罕见和最复杂的癌症. Late-stage clinical trials are more likely to show success and some are even considered standard of care in specialty areas like oncology. 像这样, providing access to and establishing trust in the clinical trials process is essential to ensure the best outcomes possible for all patients.
In part due to a painful history with clinical research and the medical community as a whole, 以及结构性经济, 地理, 以及基于交流的障碍, 有色人种在临床试验中的代表性不足, 这是造成种族医疗不平等的一个重要因素. As provider and research organizations look to progress their diversity, 股本, 和包容(DEI)的努力, a critical element will be the development of robust mechanisms and inclusive processes to ensure medical research is representative of the populations they serve.
设计代表性试验的重要性
Organizations need to understand the clinical trial panel selection process and the structural barriers it poses to accurate and equitable representation (see figure 1). 第一个, a potential trial candidate must be in a region offering the appropriate trial; most clinical trial recruitment and study visits take place at academic institutions that may be difficult to access for many underserved communities due to transportation barriers. 另外, the patient must have the economic means to participate in the trial, 包括支付旅行费用的能力, 抽出时间休息, 等.
Patients who overcome these initial barriers must also be made aware that they are eligible for a particular trial. While proactive and medically savvy patients may be able to identify a potential clinical trial and advocate on their own behalf to participate in one, most patients are unfamiliar with the intricacies of the process and therefore rely on their care team to broach the topic.
But overcoming 地理 and economic barriers is only the tip of the iceberg. Communication challenges and deep-rooted 不信任 further inhibit enrollment.
- Language barriers often make it difficult to communicate the benefits of clinical trials to non- English-speaking populations.
- 有色人种可能会用恐惧的眼光看待临床试验, 不信任, and skepticism due to their historical mistreatment and exploitation by the healthcare community in the name of medical research and scientific experimentation.
- Diversity in national academic medical school faculty and leadership is lacking, 在过去的几十年里几乎没有什么改善.2 Individuals are more likely to trust medical advice from someone with whom they identify. 像这样, inadequate representation hinders the ability for a trusting provider-patient relationship and, 反过来, 病人参加临床试验的意愿.
While adequate representation of underrepresented populations in clinical trials is essential to providing individual participants with access to cutting-edge medical treatment, it is equally critical to ensuring future patients receive tailored, 高质量的医疗云顶集团. There are countless examples of studies where the results appear clinically significant and beneficial but the participant panel insufficiently represents the broader population, 导致潜在的歧视性护理方案. It is essential to develop robustly representative trials to ensure standards of care are equitable and provide underrepresented populations the same improved clinical outcomes as their peers.
编辑: 艾米丽约翰逊
设计: 玛丽·安妮·阿库赞
