Solarin Olusola, Mohammed Sulma I, Ndlovu Ntokozo, Vanderpuye Verna, Olaiya Victoria
Savante Consulting, Lagos, Nigeria.
Department of Comparative Pathobiology, Purdue University Center for Cancer Research, West Lafayette, IN.
JCO Glob Oncol. 2020 Jun;6:954-958. doi: 10.1200/JGO.19.00194.
Africa attracts < 1% of all trials conducted around the world. The implication is that proof of safety and efficacy in Africans is lacking for a lot of new therapies. The sizeable proportion of approximately 20% of the global population that Africa represents largely does not have empiric data to support use of new therapies in a population with a distinct genetic and racial profile. Beyond the imperative of evidence-based interventions, Africans carry a disproportionately heavy burden of certain diseases, including prostate cancer, sickle cell anemia, and malaria. It therefore provides opportunity for efficient recruitment of participants for trials for such diseases. However, this advantage has not convinced sponsors to carry out clinical trials in Africa. India and China each have roughly the same population size as Africa, but each presents just one regulatory jurisdiction for clinical trials. Africa has 54 countries, and a sponsor would theoretically need to file 54 different applications to cover the entire continent. Collaboration and partnership among all stakeholders in the clinical trial ecosystem will reduce the burden on sponsors and make Africa competitive as a destination for clinical trials. Collaboration among national regulatory agencies will enable Africa to be treated as one regulatory jurisdiction and reduce administrative burden. Sites and researchers can partner to improve quality, attain necessary certifications, and increase overall efficiency. Central to all of these are clinical research organizations that can coordinate and work across borders to make clinical trial projects seamless. Ultimately, patients will benefit as quality of clinical practice improves and access to new therapies is enhanced.
非洲吸引的临床试验数量不到全球所有试验的1%。这意味着许多新疗法缺乏在非洲人身上的安全性和有效性证明。非洲人口约占全球人口的20%，但很大一部分人没有经验数据来支持在具有独特基因和种族特征的人群中使用新疗法。除了基于证据的干预措施的必要性之外，非洲人在某些疾病方面承担着不成比例的沉重负担，包括前列腺癌、镰状细胞贫血和疟疾。因此，这为高效招募此类疾病试验的参与者提供了机会。然而，这一优势并未说服赞助商在非洲开展临床试验。印度和中国的人口规模与非洲大致相同，但每个国家在临床试验方面都只有一个监管辖区。非洲有54个国家，理论上赞助商需要提交54份不同的申请才能覆盖整个大陆。临床试验生态系统中所有利益相关者之间的合作与伙伴关系将减轻赞助商的负担，并使非洲成为有竞争力的临床试验目的地。国家监管机构之间的合作将使非洲被视为一个监管辖区，并减轻行政负担。研究点和研究人员可以合作提高质量、获得必要的认证并提高整体效率。所有这些的核心是临床研究组织，它们可以跨境协调并开展工作，使临床试验项目顺利进行。最终，随着临床实践质量的提高和新疗法可及性的增强，患者将受益。
