Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct
Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct
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DOI：
10.1111/bcp.12467
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发表时间：
2015-03-01
影响因子：
3.4
通讯作者：
Turner, Mark A.
中科院分区：
文献类型：
--
作者：
Turner, Mark A.
过去，有一种观点认为，伦理和实际问题限制了新生儿研究的机会。这种看法已不再合适。现在很清楚，对用于新生儿的药物进行研究是一项伦理要求。如果研究团队适应新生儿的特点，就有可能对新生儿进行高质量的研究。良好做法包括尊重新生儿及其家庭的特殊需要，在研究设计、招募、药代动力学研究和安全性评估方面采用相关方法。新生儿病房有一种独特的文化，需要在研究环境中仔细发展。临床研究者需要认识到进行严格研究的临床和伦理必要性。行业需要在药物开发过程的早期与新生儿网络接触，最好是在联系监管机构之前。3-5年以上的随访对于评估新生儿药物至关重要，需要为此提供明确的资金，以评估对患病新生儿进行治疗的益处和风险。家长的观点必须是研究发展和研究议程的核心。伦理和实际问题不再是新生儿研究的障碍。目前的挑战是传播良好做法和最大限度地提高能力，以满足对新生儿进行研究的需要。
In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3-5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies.