Leveraging Resources and Access to Study Sites

Case Study

During a two-period, two-treatment, two-way steady-state crossover bioequivalence study of a study drug under fasting conditions, PPD worked with a client to investigate the bioequivalence of a study drug versus an approved medication in schizophrenic patients. PPD provided clinical data management, IVRS, pharmacovigilance, medical affairs and medical writing services for this study. This study proved challenging because there was an unexpectedly high number of withdrawn and unevaluable patients. PPD leveraged its resources and access to study sites to quickly counter this challenge. By adding two sites at the end of the study, PPD increased the number of enrolled patients from 56 to 68 to achieve the necessary patient enrollment level.

Even with these challenges, the time from first patient in to last patient in was 188 days—within the original six-month enrollment timeline—and database lock to the issuance of the first draft report was 24 days.

Based on this experience, PPD works with clients to proactively identify conditions that are mandatory for a patient to be considered evaluable and thus prevent any missteps throughout the process.