Bipolar Statistical Summit:Methodologies to Advance Long Term Intervention Trials

描述(申请人提供)：本提案的目的是举办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。该项目将在全美范围内向双相情感障碍的研究人员推广。这次会议将提供一个场所，将诊断、研究设计、症状表征和有效长期护理战略方面的双相方法领域的领导者聚集在一起。双相情感障碍已经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，大多数患者也有大约一半的时间在较长的时间内出现症状。生物统计学家已经开发出更严格和更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，提供更强大的能力来检测重大影响，并产生关于现实世界结果的信息，而不仅仅是双相情感障碍患者的结果。该程序还可以提高测量的可靠性，增加学习能力。最近发起的NIMH双相情感试验网络研究人员将能够在双相情感障碍的干预研究中应用建议的大量组成部分。同样，由于美国有相当大比例的双相情感障碍研究人员参加了这次会议；这些好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影响。会议的设计建议还可以加强双相情感障碍新疗法的研究方法。改善双相情感障碍预后的一个主要方法是在常规临床实践环境中更有效地应用长期干预措施。这次关于双相情感障碍的领先生物统计学家和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，并有助于开发新的治疗方法。

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.