Improving Oncology Clinical Programs by Use of Innovative Designs
View Presentation *Olga Marchenko, Quintiles Keywords: phase 2, phase 3, adaptive design, simulation, expected net present value The design of an oncology clinical program is much more challenging than the design of a separate study. The standard approach has been proven to be not very successful during the last decade; the failure rate of Phase 3 studies in oncology is about 66%. Improving the development strategy by applying innovative statistical methods is one of the major objectives for biostatisticians designing and supporting oncology clinical programs. Modeling and simulation approaches can help to optimize an individual trial, to assess the relative impact on other trials in a program, to see the benefit of novel designs, and to increase a probability of success of a clinical program by making better decisions. This presentation is built on the work of the DIA ADSWG oncology sub-tem on an Adaptive Program. With representatives from a number of institutions, this group compared several hypothetical oncology development programs using probability of the clinical program success and expected net present value (eNPV). Simulated scenarios are used to motivate and illustrate the key ideas.
|
Key Dates
-
November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC