复杂干预措施的 III 期临床试验中的阴性结果：令人担忧还是仅仅是良好的科学？
Negative results in phase III trials of complex interventions: cause for concern or just good science?
机构信息
Mike J. Crawford, FRCPsych, Kirsten Barnicot, PhD, Centre for Mental Health, Imperial College, London, UK; Sue Patterson, PhD, Metro North Mental Health, Queensland, Australia; Christian Gold, PhD, GAMUT, The Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway
Mike J. Crawford, FRCPsych, Kirsten Barnicot, PhD, Centre for Mental Health, Imperial College, London, UK; Sue Patterson, PhD, Metro North Mental Health, Queensland, Australia; Christian Gold, PhD, GAMUT, The Grieg Academy Music Therapy Research Centre, Uni Research Health, Bergen, Norway.
出版信息
Br J Psychiatry. 2016 Jul;209(1):6-8. doi: 10.1192/bjp.bp.115.179747.
Not all interventions that show promise in exploratory trials will be supported in phase III studies. But the high failure rate in recent trials of complex mental health interventions is a concern. Proper consideration of trial processes and greater use of adaptive trial designs could ensure better use of available resources.
并非所有在探索性试验中显示出前景的干预措施都能在 III 期研究中得到支持。但最近复杂心理健康干预试验的高失败率令人担忧。适当考虑试验过程并更多地采用适应性试验设计，可以确保更好地利用现有资源。
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