Marder Stephen R
Semel Institute of Neuroscience, University of California at Los Angeles, Calif, USA.
Dialogues Clin Neurosci. 2006;8(1):109-13. doi: 10.31887/DCNS.2006.8.1/smarder.
The US National Institute of Mental Health supported an initiative to facilitate the development of pharmacological agents for enhancing neurocognition in patients with schizophrenia. This has been accomplished through a consensus-building process that has included representatives from academia, the pharmaceutical industry, and government. The group has addressed obstacles to drug development that include (i) the lack of a well-accepted instrument for measuring neurocognition in clinical trials; (ii) the lack of a consensus on the best molecular target or targets for drug development; (iii) the lack of a consensus regarding the optimal trial design for either comedication that improves cognition when added to an antipsychotic or a broad spectrum agent that improves cognition and treats psychosis; and (iv) the approaches of regulatory agencies such as the US Food and Drug Administration to approving and labeling a new agent.
美国国立精神卫生研究所资助了一项倡议,以促进开发用于增强精神分裂症患者神经认知功能的药物制剂。这一目标是通过一个建立共识的过程实现的,该过程的参与者包括学术界、制药行业和政府的代表。该小组探讨了药物开发过程中存在的障碍,这些障碍包括:(i)在临床试验中缺乏一个被广泛接受的测量神经认知功能的工具;(ii)在药物开发的最佳分子靶点方面缺乏共识;(iii)对于添加到抗精神病药物中可改善认知功能的联合用药或既能改善认知功能又能治疗精神病的广谱药物的最佳试验设计缺乏共识;以及(iv)美国食品药品监督管理局等监管机构批准和标注新药的方式。