de Oliveira Avellar William, Ferreira Édria Aparecida, Vieira Ana Carolina Rodrigues Alves, de Melo Andreia Cristina, Aran Veronica
Division of Clinical Research and Technological Development, Brazilian National Cancer Institute (INCA), Rua André Cavalcanti 37, Bairro de Fátima, Rio de Janeiro 20231-050, Brazil.
Instituto Estadual do Cérebro Paulo Niemeyer (IECPN), Rua do Rezende, 156-Centro, Rio de Janeiro 20231-092, Brazil.
Healthcare (Basel). 2023 Jun 15;11(12):1753. doi: 10.3390/healthcare11121753.
Increased global cancer incidence rates have led to a growing demand for cancer diagnosis and treatment, as well as basic and clinical research on the subject. The expansion of clinical cancer trials beyond the borders of highly developed countries has aided the arrival of these assessments in South American countries. In this context, this study's objective is to highlight clinical cancer trial profiles developed and sponsored by pharmaceutical companies and conducted in South American countries from 2010 to 2020.
This study comprises descriptive and retrospective research conducted following a search for clinical trials (phases I, II and III), registered at clinicaltrials.gov, carried out in Latin American countries and sponsored by pharmaceutical companies ("Argentina", "Brazil", "Chile", "Peru", "Colombia", "Ecuador", "Uruguay", "Venezuela", "Paraguay", "Bolivia"), registered between 1 January 2010 and 31 December 2020. A total of 1451 clinical trials were retrieved, of which 200 trials unrelated to cancer were excluded and 646 duplicates were removed, leading to a final total of 605 clinical trials employing qualitative and quantitative analyses.
A 122% increase in the number of clinical trial registrations from 2010 to 2020 was noted, with a prevalence of phase III studies (431 trials of a total of 605). Lung (119), breast (100), leukemia (42), prostate (39) and melanoma (32) were the main cancers tested for new drugs.
The data reported herein indicate the need for strategic basic and clinical research planning that considers South American epidemic cancer profiles.
全球癌症发病率上升导致对癌症诊断与治疗以及该领域基础和临床研究的需求不断增加。临床癌症试验在高度发达国家以外地区的扩展,助力了这些评估在南美国家的开展。在此背景下,本研究的目的是突出2010年至2020年期间由制药公司开展并在南美国家进行的临床癌症试验概况。
本研究包括描述性和回顾性研究,通过检索在clinicaltrials.gov上注册的、在拉丁美洲国家开展且由制药公司赞助(“阿根廷”“巴西”“智利”“秘鲁”“哥伦比亚”“厄瓜多尔”“乌拉圭”“委内瑞拉”“巴拉圭”“玻利维亚”)的临床试验(I期、II期和III期),检索时间为2010年1月1日至2020年12月31日。共检索到1451项临床试验,其中排除200项与癌症无关的试验,并去除646项重复试验,最终共605项临床试验采用定性和定量分析。
2010年至2020年临床试验注册数量增加了122%,其中III期研究占比最高(605项试验中共有431项)。肺癌(119项)、乳腺癌(100项)、白血病(42项)、前列腺癌(39项)和黑色素瘤(32项)是测试新药的主要癌症类型。
本文报告的数据表明,需要进行战略基础和临床研究规划,以考虑南美地区的癌症流行情况。