Lara Olivia D, Allen Kathryn, Yakubov Amin, Pothuri Bhavana
Division of Gynecologic Oncology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Department of Obstetrics and Gynecology and Medicine, Division of Gynecologic Oncology, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, NY, USA.
Gynecol Oncol Rep. 2024 Aug 31;55:101495. doi: 10.1016/j.gore.2024.101495. eCollection 2024 Oct.
Racial and ethnic minorities remain underrepresented in clinical trials . Underrepresentation of racial groups leads to the selection of therapeutic interventions that may not be representative of the population expected to use the medicine. This study evaluates the effectiveness of a set of implementation strategies to increase underrepresented patients in gynecologic cancer clinical trials.
An interrupted time series analysis evaluating implementation strategies (pre-screening and fast-track referral) was conducted from January 2021 to May 2022. Descriptive analysis of gynecologic oncology patient screening and accrual was compared before and after intervention implementation.
During the study period (pre- and post-intervention), 26 patients were screened, and 9 patients enrolled in therapeutic gynecologic cancer clinical trials. Prior to the intervention, 7 patients were screened and 2 patients enrolled onto a clinical trial. Following the intervention, 19 patients were screened and 7 patients enrolled in a cancer clinical trial. Black patients comprised 13 of 19 (68.4%) of patients post-intervention compared to 1 of 7 (14.3 %) of patients screened pre-intervention (p < 0.05). All 7 patients enrolled post intervention were racial and ethnic minorities (non-Hispanic Black [4 of 7] and Hispanic White [3 of 7]) compared to no minority patients enrolled pre-intervention (p < 0.05). Screening increased 2.5-fold for all patients, and 5- fold for minority patients. Clinical trial enrollment increased 3.5-fold following intervention.
A combination of pre-screening and fast-track referral intervention in a racial and ethnically diverse urban academic hospital was associated with a significant increase in minority screening and enrollment. Structured strategies to overcome barriers to underrepresented racial and ethnic patient accrual in academic hospitals are urgently warranted.
临床试验中种族和少数族裔的代表性仍然不足。种族群体代表性不足导致所选择的治疗干预措施可能无法代表预期使用该药物的人群。本研究评估了一套实施策略在增加妇科癌症临床试验中代表性不足患者方面的有效性。
于2021年1月至2022年5月进行了一项中断时间序列分析，以评估实施策略（预筛查和快速通道转诊）。比较了干预实施前后妇科肿瘤患者筛查和入组情况的描述性分析。
在研究期间（干预前后），共筛查了26例患者，9例患者入组了妇科癌症治疗临床试验。干预前，筛查了7例患者，2例患者入组临床试验。干预后，筛查了19例患者，7例患者入组癌症临床试验。干预后19例患者中有13例（68.4%）为黑人患者，而干预前筛查的7例患者中有1例（14.3%）为黑人患者（p<0.05）。干预后入组的所有7例患者均为种族和少数族裔（非西班牙裔黑人[7例中的4例]和西班牙裔白人[7例中的3例]），而干预前无少数族裔患者入组（p<0.05）。所有患者的筛查增加了2.5倍，少数族裔患者的筛查增加了5倍。干预后临床试验入组增加了3.5倍。
在一家种族和民族多样化的城市学术医院中，预筛查和快速通道转诊干预相结合与少数族裔筛查和入组的显著增加相关。迫切需要制定结构化策略以克服学术医院中代表性不足的种族和族裔患者入组的障碍。
