Trends in Randomized FDA Registration Trial Design in Hematology and Oncology Trials Over Time

Poster Number: P185
Presentation Time: 05:00 PM - 06:30 PM

Abstract Keywords: Data Mining, Healthcare Quality, Internal Medicine or Medical Subspecialty, Drug Discoveries, Repurposing, and Side-effect
Primary Track: Applications
Programmatic Theme: Clinical Research Informatics

The predominant trial design for FDA approval in emerging oncological therapies is generally an escalatory approach. In contrast to introducing novel therapeutic schemes, these studies incorporate the investigated drug into existing regimens. Our analysis, spanning October 2004 to the present, not only shows the increase of escalatory design in general but highlights a need to consider trial design as a crucial factor in evaluating FDA approvals.

Speaker(s):
Aidan Petrovich, MD
Northside Hospital

Author(s):
Aidan Petrovich, MD - Northside Hospital; Jeremy Warner, MD, MS - Brown University; Wayne Liang, MD MS FAMIA - Children's Healthcare of Atlanta & Emory University; Samuel Rubinstein, MD, MSCI - University of North Carolina-Chapel Hill School of Medicine;