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

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis

Recent advances in the treatment of multiple sclerosis represent the most significant therapeutic success in neurology since the introduction of L-dopa for Parkinsonism 40 years ago. Traditional clinical trials in MS have required large numbers of subjects for a period of six months or longer. However, due to the intense competition for MS subjects, as well as technological advances and understanding of imaging techniques, MS clinical trial design is evolving. Efficient and focused subject recruitment approaches, combined with state-of-the-art trial design, are required to assess the large number of potential therapeutics in the clinical development pipeline.

In this audio conference, Dr. Peroutka discusses recent successes in MS treatment and provides attendees with practical knowledge concerning CNS clinical research, the competitive MS landscape and the analytic approach to MS subject recruitment. He also shares his insights on the conduct of MS studies, including how to leverage global experience locally.

Current Trends in Clinical Neuroscience: A Focus on Multiple Sclerosis is being presented by Dr. Stephen Peroutka, Vice President, Neurosciences, Scientific Affairs, with PRA International and airs on Thursday, October 1, 2009. For more details or to register, please visit our site at www.fxconferences.com