TL30: How to define the minimum clinically important difference for a clinical trial
*Amy T Ko, Merck & Co., Inc.
With the advancement in treatment options and therapeutic agents, particularly in the area of biologicals, defining a clinically meaningful difference between a test agent and the comparator has become increasingly difficult. However, the sample size of a study and the cost of it, and ultimately, the approval of the test agent all hinge on the accurate definition of such a difference. An accurate definition here should represent the clinical aspects of the disease and the interests of the patients, the regulators, and the company. This round table provides an opportunity for all to share their experiences and viewpoints in this difficult topic.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC