MacLeod S M, Knoppert D C, Stanton-Jean M, Avard D
Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada,
Paediatr Drugs. 2015 Feb;17(1):83-90. doi: 10.1007/s40272-014-0103-3.
Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which will allow all those involved, and especially child patients, to benefit from the advancement of therapeutics.
低收入国家临床研究试验中的潜在儿童参与者往往很脆弱，原因包括贫困、高发病率和死亡率、教育不足以及当地文化规范各异。然而，绝不能将脆弱性本身视为阻碍儿童从合理临床研究可能带来的健康益处中受益的障碍。随着越来越强调对儿童进行循证治疗，可以预期会有越来越多的呼声要求就指导低收入国家临床研究的原则达成一致。现在人们普遍接受这样的观点，即必须保护儿童免受非循证干预和不合格治疗的影响。剩下的问题涉及如何最好地推动能满足发展中国家婴幼儿、儿童和青少年需求的临床研究活动，以及如何最好地优先开展符合伦理道德且能满足他们临床需求的研究。在低收入国家，39%的公民年龄在13岁及以下，因此可以肯定的是，一些新治疗产品的临床研究将更频繁地在那里进行。本综述为有助于实现更有效伦理考量的方法提供了一些建议，包括：（1）提高研究伦理委员会的质量；（2）促进重要利益相关者之间的合作伙伴关系；（3）齐心协力建设能力；（4）提高同意和豁免程序的质量；（5）为统一的伦理平台制定更好的治理措施。国际组织需要持续提供支持，以维持建立和维护更强大的研究伦理委员会，从而保护参与临床试验的儿童。本综述强调了在发达国家和低收入国家组织之间培养团结文化和真正伙伴关系的重要性，这将使所有相关方，尤其是儿童患者，能够从治疗学的进步中受益。
