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Abstract：
Because the results of clinical trials of investigational treatments influence regulatory policy, prescribing patterns, and use in clinical practice, high quality trials are an essential component of the evidence base for migraine. The International Headache Society has published guidelines for clinical trials in adults with migraine since 1991. With multiple issues specific to children and adolescents with migraine, as well as the emergence of novel trial designs and advances in pharmaceuticals, biologics, devices, and behavioural interventions, there is a need for guidance focusing on issues specific to the conduct of clinical trials in children and adolescents with migraine.
The objective of these guidelines is to provide a contemporary, standardized, and evidence-based approach to the design, conduct, and reporting of well-controlled clinical trials of preventive treatment of migraine in children and adolescents.
The development of these guidelines was based on guidelines previously published by the International Headache Society and regulatory bodies. The recommendations are evidence-based, where available. The process included consultations among various committees, roundtable discussions among stakeholders (lay people and the pharmaceutical industry), and open consultation with the IHS membership on the final draft.
A series of recommendations addressing the major issues in clinical trials in children and adolescents with migraine is provided. Recommendations are supported by evidence-based practice and validated methodologies, where available. Supporting comments are provided to clarify ambiguities.
These guidelines should be consulted and used in designing and conducting clinical trials of preventive treatments in children and adolescents with migraine.
The objective of these guidelines is to provide a contemporary, standardized, and evidence-based approach to the design, conduct, and reporting of well-controlled clinical trials of preventive treatment of migraine in children and adolescents.
The development of these guidelines was based on guidelines previously published by the International Headache Society and regulatory bodies. The recommendations are evidence-based, where available. The process included consultations among various committees, roundtable discussions among stakeholders (lay people and the pharmaceutical industry), and open consultation with the IHS membership on the final draft.
A series of recommendations addressing the major issues in clinical trials in children and adolescents with migraine is provided. Recommendations are supported by evidence-based practice and validated methodologies, where available. Supporting comments are provided to clarify ambiguities.
These guidelines should be consulted and used in designing and conducting clinical trials of preventive treatments in children and adolescents with migraine.
摘要：
因为研究治疗的临床试验结果会影响监管政策，处方模式，并在临床实践中使用，高质量的试验是偏头痛证据基础的重要组成部分.国际头痛协会自1991年以来发布了成人偏头痛临床试验指南。针对儿童和青少年偏头痛的多个问题，以及新的试验设计和药物进步的出现，生物制剂,设备,和行为干预，有必要针对儿童和青少年偏头痛临床试验的具体问题提供指导.
这些准则的目的是提供一个当代的，标准化，和基于证据的设计方法，行为,并报告了儿童和青少年偏头痛预防性治疗的受控临床试验。
这些指南的制定是基于国际头痛协会和监管机构先前发布的指南。这些建议是基于证据的，可用的地方。这一进程包括各委员会之间的协商，利益相关者(非专业人士和制药业)之间的圆桌讨论，并就最终草案与IHS成员进行公开磋商。
提供了一系列针对儿童和青少年偏头痛临床试验中的主要问题的建议。建议得到基于证据的实践和经过验证的方法的支持，可用的地方。提供支持意见以澄清歧义。
在设计和开展儿童和青少年偏头痛预防性治疗的临床试验时，应参考和使用这些指南。
这些准则的目的是提供一个当代的，标准化，和基于证据的设计方法，行为,并报告了儿童和青少年偏头痛预防性治疗的受控临床试验。
这些指南的制定是基于国际头痛协会和监管机构先前发布的指南。这些建议是基于证据的，可用的地方。这一进程包括各委员会之间的协商，利益相关者(非专业人士和制药业)之间的圆桌讨论，并就最终草案与IHS成员进行公开磋商。
提供了一系列针对儿童和青少年偏头痛临床试验中的主要问题的建议。建议得到基于证据的实践和经过验证的方法的支持，可用的地方。提供支持意见以澄清歧义。
在设计和开展儿童和青少年偏头痛预防性治疗的临床试验时，应参考和使用这些指南。
