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

用于加强临床研究患者招募的智能在线系统

• 批准号: 7747426
• 负责人: DEENDAYAL DINAKARPANDIAN
• 金额: $ 25.91万
• 依托单位: MIDWEST PSYCHIATRIC RESEARCH GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7747426
• 关键词: Address; Applications Grants; Binding; Caregivers; Categories; Cereals; Characteristics; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Collection; Commit; Complex; Computer Security; Computer Systems Development; Computers; Data; Data Quality; Databases; Development; Diagnostic; Disease; Education; Effectiveness; Elements; Enrollment; Ethicists; Exclusion Criteria; Family Caregiver; Feedback; Figs - dietary; Focus Groups; Generalized Anxiety Disorder; Goals; Human Volunteers; Individual; Industry; Information Management; Informed Consent; Internet; Knowledge; Lead; Linear Models; Major Depressive Disorder; Mass Media; Mental disorders; Methodology; Methods; Modeling; Modification; Mood Disorders; Nature; Online Systems; Participant; Patient Recruitments; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Population; Process; Protocols documentation; Psychiatrist; Psychologist; Published Comment; Recruitment Activity; Relative (related person); Research; Research Contracts; Research Design; Research Ethics Committees; Research Infrastructure; Research Personnel; Resource Development; Resources; Schizophrenia; Scientist; Screening procedure; Site; Small Business Innovation Research Grant; Speed; Stream; System; Time; Update; Vulnerable Populations; base; commercialization; computer science; database design; design; disability; disease diagnosis; drug development; experience; healthy volunteer; human subject; improved; information organization; interest; iterative design; meetings; member; novel; performance tests; protocol development; prototype; public health relevance; satisfaction; software systems; success; volunteer; web site

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.

描述（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效率低下且耗时的过程。对于患有精神疾病的弱势群体来说尤其如此。该SBIR I期申请将开发一个用于招募增强的原型，该原型具有一个新型的基于互联网的系统，该系统将主动吸引希望了解临床试验的患者及其护理人员，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入选/排除标准的可能性。该系统将经常更新，并包含一个积极的教育组成部分，为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、信息充分的招募人群，这将提高知情同意人群。原型将侧重于开发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。原型开发将涉及开发一个新的网站界面，并结合智能数据库设计。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系统的设计。模拟招募研究还将测试该系统的性能参数。发展将保持重点放在功能，这将是适销对路的制药公司，合同研究组织和临床试验网站。这些功能将加快招聘过程，提高保留率，并有助于协议的制定。公共卫生相关性：精神疾病，如广泛性焦虑症，在世界范围内造成严重残疾。该项目将试图开发一个基于计算机和互联网的系统，以显著改善最适合研究的患者的招募，以开发更好的药物治疗这些疾病。