Resende Heloisa, Arai Roberto J, Barrios Carlos H, Schwyter Fernanda, Teich Nelson L S, Gomes Andre, Dallari Analluza B, Bonilha Laís A S, Souza Claudiosvam M A, Francisco Fernando R, Munhoz Rodrigo R, Werutsky Gustavo, Madi Marisa, Fernandes Paulo, Figueiredo Jose M, Fedozzi Fabio, Arruda Lilian, Aguiar Vinícius Q, Melo Andreia C
Instituto Projeto Cura, São Paulo 05507-020, SP, Brazil.
https://orcid.org/0000-0003-4692-3743.
Ecancermedicalscience. 2024 Apr 18;18:1698. doi: 10.3332/ecancer.2024.1698. eCollection 2024.
Clinical research is the cornerstone of improvements in cancer care. However, it has been conducted predominantly in high-income countries with few clinical trials available in Brazil and other low-and-middle-income countries (LMIC). Of note, less than one-third of registered clinical trials addressing some of the most commonly diagnosed cancers (breast, lung and cervical) recruited patients from LMIC in the last years. The Institute Project CURA promoted the fourth CURA meeting, discussing barriers to cancer clinical research and proposing potential solutions. A meeting was held in São Paulo, Brazil, in June 2023 with representatives from different sectors: Brazilian Health Regulatory Agency (Anvisa), National Commission of Ethics in Research (CONEP), non-governmental organisations, such as the Latin American Cooperative Oncology Group, the Brazilian Society of Clinical Oncology (SBOC), Contract Research Organisations, pharmaceutical companies and investigators. A total of 16 experts pointed out achievements as shortening the time of regulatory processes involving Anvisa and CONEP, development of staff training programs, maintenance of the National Program of Oncological Attention (PRONON), and the foundation of qualified centres in North and Northeast Brazilian regions. Participants also highlighted the need to be more competitive in the field, which requires optimising ongoing policies and implementing new strategies as decentralisation of clinical research centres, public awareness campaigns, community-centered approaches, collaborations and partnerships, expansion of physicians-directed policies, exploring the role of the steering committee. Active and consistent reporting of the initiatives might help to propagate ongoing advances, increasing Brazilian participation in clinical cancer research. Engagement of all players is crucial to maintain continuous progress with further improvements in critical points including regulatory timelines and increments in qualified human resources which aligned with new educational initiatives focused on physicians and the general population will expand access to cancer clinical trials in Brazil.
临床研究是改善癌症护理的基石。然而,它主要在高收入国家进行,巴西和其他低收入和中等收入国家(LMIC)进行的临床试验很少。值得注意的是,在过去几年中,针对一些最常见诊断癌症(乳腺癌、肺癌和宫颈癌)的注册临床试验中,只有不到三分之一从低收入和中等收入国家招募患者。CURA研究所项目促成了第四次CURA会议,讨论了癌症临床研究的障碍并提出了潜在的解决方案。2023年6月在巴西圣保罗举行了一次会议,来自不同部门的代表出席:巴西卫生监管机构(Anvisa)、国家研究伦理委员会(CONEP)、非政府组织,如拉丁美洲肿瘤合作组织、巴西临床肿瘤学会(SBOC)、合同研究组织、制药公司和研究人员。共有16位专家指出了一些成就,如缩短涉及Anvisa和CONEP的监管流程时间、制定员工培训计划、维持国家肿瘤护理计划(PRONON)以及在巴西北部和东北部地区建立合格的中心。与会者还强调需要在该领域更具竞争力,这需要优化现行政策并实施新战略,如临床研究中心的分散化、公众意识宣传活动、以社区为中心的方法、合作与伙伴关系、扩大以医生为主导的政策、探索指导委员会的作用。积极且持续地报告这些举措可能有助于传播正在取得的进展,增加巴西在临床癌症研究中的参与度。所有参与者的参与对于保持持续进展至关重要,在包括监管时间表和合格人力资源增加等关键点上进一步改进,这些改进与针对医生和普通民众的新教育举措相一致,将扩大巴西癌症临床试验的可及性。