McLean Hospital, Schizophrenia and Bipolar Disorder Program, 115 Mill St., Belmont, MA, USA; Harvard Medical School, Department of Psychiatry, 401 Park Drive, Boston, MA, USA.
McLean Hospital, Schizophrenia and Bipolar Disorder Program, 115 Mill St., Belmont, MA, USA; Harvard Medical School, Department of Psychiatry, 401 Park Drive, Boston, MA, USA.
Schizophr Res. 2018 Feb;192:6-8. doi: 10.1016/j.schres.2017.06.010. Epub 2017 Jun 17.
Recently, the focus of funding mechanisms associated with clinical trials has changed to be consistent with an experimental therapeutics approach. While this approach holds considerable promise, the paradigm shift has presented challenges for behavioral trials in complex psychiatric illness such as schizophrenia, as molecular targets - the classic focus in experimental therapeutics paradigms - may not represent logical targets for many psychosocial interventions designed to treat multifaceted, multiply determined symptoms. Clear guidelines for alternate models have not been offered, leaving large numbers of clinical trials researchers unclear about how to frame their work. We address some of the challenges for behavioral interventions research, and offer guidance for the development of novel approaches to the application of a target engagement framework to behavioral clinical trials.
最近，与临床试验相关的资助机制的重点已经转变为与实验治疗方法一致。虽然这种方法有很大的前景，但这种范式的转变给精神分裂症等复杂精神疾病的行为试验带来了挑战，因为分子靶点——实验治疗范式的经典焦点——可能不是许多旨在治疗多方面、多重决定症状的心理社会干预的逻辑靶点。目前还没有提供替代模型的明确准则，使得大量临床试验研究人员不清楚如何构建他们的工作。我们解决了行为干预研究的一些挑战，并为将目标参与框架应用于行为临床试验的新方法的开发提供了指导。
