While Phase II-III studies include small datasets, comprising several hundred to several thousand patients, they provide the data necessary for drug approvals. The FDA approval of a drug is contingent on the drug company designing and implementing a post-marketing, or Phase IV study, designed to obtain additional data in a larger, real-world patient population. Join Dr. Keith Coffee as he explores how and why practicing physicians agree to participate in Phase IV studies. He will also address the common concerns many physicians raise regarding time spent and reimbursement for participating in these studies.
Is Marijuana a Replacement for Opioids?
THE INSIGHT SERIES: Do Late Phase Studies Offer Any Scientific Value? – Part 2
The growing focus on post-marketing and observational research has brought a heightened awareness, and scrutiny, on the design and execution of these…
Meeting Enrollment Goals Breast Cancer
An open-label, randomized, multi-center study to evaluate the use of Study Drug in the prevention of cancer treatment-related bone loss in…