Department of Vascular Surgery, Miller Family Heart Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, OH.
Cleveland Clinic Lerner College of Medicine, Cleveland, OH.
Ann Vasc Surg. 2024 Nov;108:355-364. doi: 10.1016/j.avsg.2024.05.034. Epub 2024 Jul 14.
Clinical trial enrollment provides various benefits to study participants including early access to novel therapies that may potentially alter the trajectory of disease states. Trial sponsors benefit from enrolling demographically diverse trial participants enabling the trial outcomes to be generalizable to a larger proportion of the community at large. Despite these and other well-documented benefits, clinical trial enrollment for Black and Hispanic Americans as well as women continues to be low. Specific disease states such as peripheral artery disease (PAD) have a higher prevalence and clinical outcomes are relatively worse in Black Americans compared with non-Hispanic white Americans. The recruitment process for PAD clinical trials can be costly and challenging and usually comes at the expense of representation. Participant willingness and trust, engagement, and socioeconomic status play essential roles in the representation of under-represented minority (URM) groups. Despite the contrary belief, URM groups such as Blacks and Hispanics are just as willing to participate in a clinical trial as non-Hispanic Whites. However, financial burdens, cultural barriers, and inadequate health literacy and education may impede URMs' access to clinical trials and medical care. Clinical trials' enrollment sites often pose transportation barriers and challenges that negatively impact creating a diverse study population. Lack of diversity among a trial population can stem from the stakeholder level, where corporate sponsors of academic readers do not consider diversity in clinical trials a priority due to false cost-benefit assumptions. The funding source may also impact the racial reporting or the results of a given trial. Industry-based trials have always been criticized for over-representing non-Hispanic White populations, driven by the desire to reach high completion rates with minimum financial burdens. Real efforts are warranted to ensure adequate minorities' representation in the PAD clinical trials and to the process toward the ultimate goal of developing more durable and effective PAD treatments that fit the needs of real-world populations.
临床试验入组为研究参与者提供了各种益处，包括早期获得可能改变疾病状态轨迹的新型疗法。试验赞助商从招募具有不同人口统计学特征的试验参与者中受益，使试验结果能够推广到更广泛的社区。尽管有这些和其他记录在案的好处，但黑人和西班牙裔美国人和女性参与临床试验的比例仍然很低。特定的疾病状态，如外周动脉疾病 (PAD)，在黑人群体中的患病率较高，临床结局相对较差，而非西班牙裔白人群体。PAD 临床试验的招募过程可能成本高昂且具有挑战性，通常以代表性为代价。参与者的意愿和信任、参与度以及社会经济地位在外来少数群体 (URM) 群体的代表性中起着至关重要的作用。尽管存在相反的观点，但像黑人或西班牙裔这样的 URM 群体与非西班牙裔白人一样愿意参与临床试验。然而，经济负担、文化障碍以及不足的健康素养和教育可能会阻碍 URM 参与临床试验和获得医疗服务。临床试验的入组地点经常存在交通障碍和挑战，这对建立多样化的研究人群产生负面影响。试验人群缺乏多样性可能源于利益相关者层面，学术研究赞助商的企业赞助商由于错误的成本效益假设，并不认为临床试验中的多样性是优先事项。资金来源也可能影响特定试验的种族报告或结果。基于行业的试验一直因渴望以最小的财务负担达到高完成率而受到批评，它们过度代表非西班牙裔白人人群。为了确保在 PAD 临床试验中充分代表少数族裔，并朝着最终开发出更耐用和有效的 PAD 治疗方法的目标迈进，以满足真实人群的需求，确实需要做出真正的努力。
