Overcoming Complexity On A Phase 2 Glaucoma Study
Overcoming Complexity On A Phase 2 Glaucoma Study
2 PagesOvercoming Complexity on a Phase 2 Glaucoma Study The Specific Situation • A P hase I/II multi-sit e study needed t o enr oll mor e than 100 pa tien ts acr oss thr ee distinc t c ohor ts on an e x c eeding c omple x pr ot oc ol: • T he Sponsor implemen t ed 7 pr ot oc ols amendmen ts o v er 13 mon ths . Ho w c ould the sponsor find enough pa tien ts who c ould meet the str ingen t enr ollmen t standar ds and stick with the pr og r am? TH
