Backup Strategy Proves Valuable in Hepatitis C Study

Case Study

PPD was involved in a study that compared weight-based doses of a study drug combined with an antineoplastic agent to an antiviral combined with an antineoplastic agent in therapy-naïve patients with chronic hepatitis virus genotype 1 infection.

PPD provided clinical monitoring, project management, medical management, biostatistics, data management, quality assurance, electronic data capture (EDC) setup and support to the sites, and pharmacovigilance on the Phase IIb multicenter, randomized, open-label study. The study was looking for a drug’s optimal dose by comparing the efficacy and safety of three drug dose levels versus an antiviral. Both of the drugs were administered in combination with an antineoplastic agent to therapy-naïve patients for a treatment period through week 48 and then a 24-week follow-up period. The study included 278 patients, 57 sites and a 29-month timeline.

The challenge for the study was slow recruitment of patients with genotype 1. PPD proactively identified the area of enrollment concern at the onset of the study and prepared a backup strategy to access these patients through additional sites. While the original set of sites had started to recruit, the project team collected the appropriate data identifying the key risk to enrollment. PPD immediately enlisted an additional 15 sites for the study for a total of 57 sites. As a result, PPD met the original enrollment timeline relayed to the client.