This proposal seeks to evaluate innovative approaches to overcome major limitations in the way that multi- center clinical trials are currentl conducted by proposing and testing novel methods for study subject recruitment, informed consent, subject retention, study site, data collection, and protocol adherence. The study will take advantage of the extensive opportunities the internet provides for conducting research and reaching patients who live far from major academic medical centers. The proposed study will evaluate the role of social media and the efficacy of using online methods for recruitment and consenting to overcome limitations of traditional subject recruitment and enrollment through Centers of Excellence. The study will also explore the validity of data obtained directly from study subjects as compared to data obtained from treating physicians. The 2 x 2 factorial design (recruitment on-line vs. CoE~ and data sources of patients vs. physicians) will allow for comparative effectiveness assessment of critical clinical trial parameters such as recruitment, retention, data quality, and protocol adherence. A qualitative analysis will be used to determine the overall acceptability of the novel approaches by both patients and physicians and provide addition data to evaluate the relative efficacy of the new and traditional trial methods. Thes novel approaches to clinical trials will be evaluated in the context of a clinically important randomized trial for patients with granulomatosis with polyangiitis (Wegener's). The research will be conducted by the Vasculitis Clinical Research Consortium, a multi-center clinical research infrastructure sponsored by the NIH. The VCRC has extensive experience designing and conducting clinical trials and includes the sophisticated and large resources of the Data Management Coordinating Center. Co- investigators with content expertise in patient consenting, qualitative research methods, internet marketing, and process evaluation complete the investigative team. The results of this study will be generalizable to more common diseases and, if successful, will provide major advances in conducting more efficient multi-center clinical trials.
This proposal seeks to evaluate innovative approaches to overcome major limitations in the way that multi- center clinical trials are currently conducted by proposing and testing novel methods for study subject recruitment, subject retention, and protocol adherence. The study will take advantage of the extensive opportunities the internet provides for conducting research and reaching patients who live far from major academic medical centers. These measures will be evaluated in the context of a clinically important randomized trial for patients with granulomatosis with polyangiitis (Wegener's). The results will be generalizable to more common diseases and, if successful, will provide a major advance in conducting more efficient multi-center clinical trials.
