Case Study

Overcoming Adverse Event Challenges To Ensure Subject Safety In An Osteoarthritis Study

Source: PRA Health Sciences
Overcoming Adverse Event Challenges To Ensure Subject Safety In An Osteoarthritis Study

A double blind, placebo controlled, parallel group, randomized study to evaluate the safety, tolerability, and efficacy of a novel, orally available small molecule for treatment of pain in osteoarthritis (OA).

PRA Health Sciences was contracted by a pharmaceutical company to conduct the sponsor’s study to determine the safety, tolerability, and efficacy of a chemical entity in subjects with OA. During the study, PRA received reports from clinical investigators about adverse events (AEs) leading to multiple subjects dropping out following exposure to the IMP.