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.
THE INSIGHT SERIES: Can you use the same outsourcing methodologies for post-marketing studies as pre-approval research? - Part 4
As the number of preferred provider relationships grow and become more sophisticated, budget grids and assumptions must align with the needs of…
Exploring Real-World Outcomes
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…