Summary

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. There was a significant reduction in study dropout (28% to 2.6%) after IMP dose adjustment that required amendment of the Phase IIa protocol and obtaining required approvals, as well as IC before study enrollment process resumed.

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Overcoming Adverse Event Challenges