Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues was presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and aired on 2009-05-19. For more details or to download this event, please visit our site at www.fxconferences.com

Adaptive Trial Design: Streamlining the Clinical Supply Process

Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.

From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).

Adaptive Trial Design: Streamlining the Clinical Supply Process was presented by Geert Langendries, with Covance IVRS Project Management Group and aired on 2007-12-05. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Adaptive/Novel Designs in Oncology: Overview & Issues

Oncology trials have long been at the forefront of novel design thinking, due in part to the extreme needs and historically toxic or complex therapies for cancer. With FDA's Critical Path Initiative and the general urgent need for more efficient clinical development adaptive designs, these trials are receiving increased attention. There is a call to modernize drug development and utilize bioinformation to evaluate safety and effectiveness.

Adaptive designs have become popular tools in oncology research, helping to achieve more effective and affordable trials. This conference gives an overview of adaptive design thinking and issues, and explores their place in oncology trial design.

Adaptive/Novel Designs in Oncology: Overview & Issues is being presented by Dr. John Constant, Vice President Scientific Affairs, Statistical Consulting, Oncology/Hematology, with PRA International and airs on Tuesday, May 19, 2009. For more details please visit our site at www.fxconferences.com