Gopishetty Swathi, Kota Vamsi, Guddati Achuta K
Medical Center of Central Georgia, Mercer University Macon, GA 31201, The United States.
Division of Hematology/Oncology, Georgia Cancer Center, Augusta University Augusta, GA 30909, The United States.
Am J Transl Res. 2020 Sep 15;12(9):5977-5983. eCollection 2020.
Geriatric patients and minority patients are often under-represented in cancer clinical trials. The presence of multiple comorbidities makes geriatric patients ineligible for most clinical trials. Racial diversity may vary by geographical location and socio-economically backward areas may have a very different racial mix. The increase in cancer incidence in geriatric patients' raises the question of applicability of the results is such clinical trials. This study also explores the representation of different races in phase 3 clinical trials conducted in the past 10 years. Data about Phase III trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The time period studied was for the past 10 years and included only adult patients (≥18 years). The age and race distribution of the patient population in these trials were extracted and analyzed. Geriatric patients and minorities are under-represented in all phase III cancer clinical trials. The range of the proportion of geriatric patients varied from 10% to 40%. African American and Asian patients are under-represented in all phase III cancer clinical trials. The results of phase III clinical trials that are currently conducted on non-geriatric and Caucasian patient population may not meaningfully be applicable to geriatric patients and minorities. This study highlights the disparity of age and race for patients enrolled in clinical trials as against the patients seen in the real world.
老年患者和少数族裔患者在癌症临床试验中的代表性往往不足。多种合并症的存在使老年患者没有资格参加大多数临床试验。种族多样性可能因地理位置而异，社会经济落后地区的种族构成可能非常不同。老年患者癌症发病率的上升引发了此类临床试验结果适用性的问题。本研究还探讨了在过去10年进行的3期临床试验中不同种族的代表性。从临床试验.gov中提取了关于3种常见实体器官和3种血液系统恶性肿瘤[乳腺癌、结肠癌、肺癌、弥漫性大B细胞淋巴瘤（DLBCL）、急性髓系白血病（AML）和急性淋巴细胞白血病（ALL）]的III期试验数据。研究时间段为过去10年，仅包括成年患者（≥18岁）。提取并分析了这些试验中患者群体的年龄和种族分布。老年患者和少数族裔在所有III期癌症临床试验中的代表性不足。老年患者的比例范围从10%到40%不等。非裔美国人和亚洲患者在所有III期癌症临床试验中的代表性不足。目前针对非老年白种人患者群体进行的III期临床试验结果可能对老年患者和少数族裔没有实际意义。本研究突出了临床试验入组患者与现实世界中患者在年龄和种族方面的差异。
