Bipolar Statistical Summit:Methodologies to Advance Long Term Intervention Trials

描述（由申请人提供）：本提案的目的是召开一次全天的全国会议，以改进双相情感障碍长期试验的设计、统计分析和解释。该项目将推广给全美双相情感障碍的研究人员。会议将提供一个汇集双相情感障碍诊断、研究设计、症状表征和有效长期护理策略方面的领导者的场所。双相情感障碍已被理解为症状和功能复杂，即使在最佳应用专业干预的情况下，大多数患者在长时间内也有大约一半的时间出现症状。生物统计学家已经开发出更严格和复杂的统计技术来处理这些有问题的现实。这些技术处理不完整的数据，提供更强的能力来检测显著影响，并提供真实世界结果的信息，而不仅仅是双相情感障碍罕见的直接患者的结果。这些程序还可以提高测量的可靠性，增加研究能力。最近启动的NIMH双相障碍试验网络研究人员将能够在双相障碍的干预研究中应用建议的实质性组成部分。同样，参加会议的美国双相情感障碍研究人员的比例也很大；这些益处将对改善双相情感障碍治疗的长期研究的设计和推广产生广泛的影响。会议提出的设计建议也可以加强双相情感障碍新治疗方法的研究。改善双相情感障碍预后的主要方法是在常规临床实践中更有效地应用长期干预措施。本次会议的主要生物统计学家和双相情感障碍临床研究人员的会议旨在提供建议和设计方法，以促进双相情感障碍的设计和统计方法，以减轻疾病负担，改善持续的功能结果并促进新治疗方法的发展。

DESCRIPTION (provided by applicant): The purpose of this proposal is to conduct a full day national conference to improve the design, statistical analysis and interpretation of long term trials in bipolar disorders. The program will be promoted to investigators across the United States in bipolar disorders. The conference will provide a venue to bring together leaders in bipolar methodologies in diagnosis, study design, symptomatic characterization and strategies of effective long term care. Bipolar disorder has come to be understood as symptomatically and functionally complex, with most patients symptomatic approximately half of the time over long periods even in the context of optimally applied professional interventions. Biostatisticians have developed more rigorous and complex statistical techniques to deal with these problematic realities. These techniques deal with incomplete data, provide stronger power to detect significant effects, and yield information on real world outcomes, not just outcomes in uncommonly straightforward patients with bipolar disorders. The procedures can also improve reliability of measurements and increase study power. The recently initiated NIMH Bipolar Trials Network investigators will be able to apply substantial components of the recommendations in interventions studies of bipolar disorders. Similarly with a substantial proportion of bipolar investigators in the U.S. attending the conference; these benefits will have broad impact on the design and generalizability of long term studies on improving treatments for bipolar disorder. The design recommendations from the conference can also strengthen approaches to the study of new treatments for bipolar disorders. A major approach to improving outcomes in bipolar disorder entails more efficient application of long term interventions in regular clinical practice settings. This conference of leading biostatisticians and clinical investigators on bipolar disorder is structured to provide recommendations and design approaches which can advance design and statistical methodologies for bipolar disorder for purposes of reducing illness burden, improving sustained functional outcomes and contributing to development of novel treatments.