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.
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.
