Reuse and integration of healthcare information for subjects in a clinical trial for treatment of recurrent respiratory papillomatosis

摘要

This paper describes healthcare information reuse and integration in the clinical trial of a drug (Avastin) involving 20 research subjects diagnosed with recurrent respiratory papillomatosis (RRP) of the vocal cords and treated at Massachusetts General Hospital (MGH) Voice Center. The client/server application designed and developed by the author assisted in clinical trial data entry, storage in a relational database, retrieval, and reporting. The developed clinical trial software included data auditing to satisfy FDA requirements. Auxiliary import/export jobs were employed, which allowed to reuse standard MGH outpatient and surgical schedules and increased the efficiency of the clinical trial data management by avoiding data entry duplication. This clinical data processing design allowed the author to preserve integrity of the healthcare data used in the clinical trial. The clinical data integration allowed doctors to track the overall dynamics of the treatment process covering pre-trial, in-trial and post-trial examinations of the research subjects.