Abstract
This study examines the pharmaceutical industry clinical data management experience as of September 1985. It looks at data turnaround in Phase III clinical studies, data-handling systems used, and remote data entry experiences across 20 companies. Data were gathered through a Drug Information Association (DIA) Workshop Survey Form. Results: (1) It takes an average of 11 weeks to get clinical data from the patient to the company, through scrubbing, and entered into a clinical database in Phase III trials of 1 to 3 years; from entry through first analysis takes another 18 weeks; (2) there is no database standard for clinical studies; (3) there is a common analysis software; (4) there is no software standard for remote data entry (RDE); (5) a full 70% of the 20 companies intend to use RDE in future clinical studies within two years.
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