An Intelligent Online System for Enhanced Recruitment of Patients for Clinical Re

描述（由申请人提供）：临床研究受试者的招募和保留目前在新药开发行业是一个低效且耗时的过程。对于精神疾病患者这一弱势群体来说尤其如此。这个SBIR I期申请将开发一个原型，通过一个新颖的基于互联网的系统来增强招募，该系统将主动吸引那些希望了解临床试验的患者和他们的护理人员，这些临床试验可能与他们的特定诊断、疾病状态和各种其他特征相关，这些特征可能决定他们满足特定研究的纳入/排除标准的可能性。该系统将经常更新，并包含积极的教育内容，以便向新招募人员提供有关临床试验性质的信息，并提供一个特征明确、信息灵通的招募人群，从而增加知情同意人群。该原型将专注于开发用于招募精神分裂症患者和重度抑郁症患者的系统，目标是在第二阶段将该系统扩展到其他主要精神疾病。原型开发将涉及与智能数据库设计相关联的新颖网站界面的开发。从由患者、临床研究专业人员、计算机科学专业人员和伦理学家组成的焦点小组获得的信息将有助于指导和完善该系统的设计。模拟招聘研究也将测试系统的性能参数。开发将继续专注于有市场的制药公司、合同研究组织和临床试验点。这些功能将加快招聘进程，提高保留率，并有助于制定协议。公共卫生相关性：精神疾病，如广泛性焦虑症，在世界范围内造成了巨大的残疾。该项目将尝试开发一个基于计算机和互联网的系统，以显著改善招募最适合研究的患者，以开发更好的药物来治疗这些疾病。

DESCRIPTION (provided by applicant): Recruitment and retention of subjects for clinical research is currently an inefficient and time-consuming process in the new drug development industry. This is especially true for the vulnerable populations of individuals with psychiatric disorders. This SBIR Phase I application will develop a prototype for recruitment enhancement with a novel internet- based system which will proactively engage patients and their caregivers who desire to be informed about clinical trials which might be relevant for their specific diagnoses, disease states and various other characteristics which might determine their likelihood of meeting inclusion/exclusion criteria for specific studies. The system will be frequently updated and contain an active educational component for providing recruits with information about the nature of clinical trials and provide a well-characterized, well-informed recruitment population which will enhance the informed consent population. The prototype will focus on the development of systems for recruitment of schizophrenics and patients with major depressive disorder with the goal of expanding this system to other major psychiatric disorders in Phase II. Prototype development will involve development of a novel website interface in association with an intelligent database design. Information obtained from focus groups composed of patients, clinical research professionals, computer science professionals and ethicists will help guide and refine the design of the system. Mock recruitment studies will also test performance parameters of the system. Development will maintain focus on features which will be marketable pharmaceutical firms, contract research organizations and clinical trial sites. Such features will speed the recruitment process, enhance retention and also aid in protocol development. PUBLIC HEALTH RELEVANCE: Psychiatric Disorders, such as Generalized Anxiety Disorder, cause great disability worldwide. This project will attempt to develop a computer and internet-based system for significantly improving the recruitment of patients who are the most appropriate for studies designed to develop better medications for treating these illnesses.