Salhia Bodour, Olaiya Victoria
Department of Translational Research, University of Southern California, Norris Comprehensive Cancer Center, Keck School of Medicine, Los Angeles, CA.
Synteract Limited, Cambridgeshire, United Kingdom.
JCO Glob Oncol. 2020 Jun;6:959-965. doi: 10.1200/JGO.19.00196.
Clinical trials research involving human participants has led to numerous medical advances. Historically, however, clinical trials research was the source of major concerns for the safety and welfare of the human participants taking part in these studies. The ethical principles of autonomy, beneficence, and justice came about in response to medical atrocities, and regulations were ultimately put in place to protect the rights and welfare of human participants and to maintain the public trust in the research enterprise. Today, clinical trials are one of the most heavily regulated practices in the world, and yet still not all people are provided the same oversights and protections, with improprieties disproportionately affecting poor-resource nations and vulnerable populations. As Africa approaches the post-communicable disease era, cancer is set to take the lead as the most burdensome disease, making the need for oncology clinical trials in Africa greater than ever before. Africa represents a heterogeneous market with 55 countries, most with their own National Regulatory Agency (NRA) and each with varying levels of regulatory maturity. This diversity creates a highly complex regulatory environment and causes challenges when bringing drugs to market. There is a large need for harmonization and increased collaboration between the African nations' NRAs. In addition, many African countries need to be better equipped to handle research ethics committees and/or learn how to rely on neighboring countries with more established ethics committees. Well-run clinical trials offer solutions to national health care problems, and all people deserve equal access to their benefits.
涉及人类受试者的临床试验研究带来了众多医学进步。然而，从历史上看，临床试验研究曾是参与这些研究的人类受试者的安全和福祉的主要担忧来源。自主、行善和公正等伦理原则是为应对医疗暴行而产生的，最终制定了相关法规以保护人类受试者的权利和福祉，并维持公众对研究事业的信任。如今，临床试验是世界上监管最为严格的实践之一，但仍并非所有人都能得到相同的监督和保护，不当行为对资源匮乏国家和弱势群体的影响尤为严重。随着非洲进入后传染病时代，癌症将成为负担最重的疾病，这使得非洲对肿瘤学临床试验的需求比以往任何时候都更加迫切。非洲是一个由55个国家组成的多样化市场，大多数国家都有自己的国家监管机构（NRA），且每个国家的监管成熟度各不相同。这种多样性创造了一个高度复杂的监管环境，并在将药物推向市场时带来挑战。非洲各国的国家监管机构非常需要进行协调并加强合作。此外，许多非洲国家需要更好地配备处理研究伦理委员会的能力，和/或学习如何依靠周边拥有更成熟伦理委员会的国家。运行良好的临床试验为国家医疗保健问题提供了解决方案，所有人都应该平等地受益于临床试验。
