is being presented by Dr. John Constant, Vice President Scientific Affairs, with PRA International and airs on Wednesday, May 26th, 2010. For more details or to register, please visit our site at www.fxconferences.com
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 the regulatory Critical Path Initiatives and the general urgent need for more efficient clinical development adaptive and other patient – efficient designs are continuing to receive increasing attention and FDA has recently published their long-awaited Guidance on adaptive designs. This session will overview recent developments in oncology design thinking and issues related to adaptive, single arm and Phase I/II designs as used in practice in oncology trials.
Showing posts with label phase II. Show all posts
Showing posts with label phase II. Show all posts
Thursday, April 15, 2010
Wednesday, October 7, 2009
Studies in Special Patient Populations: More than Just a Regulatory Requirement
In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.
In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.
Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.
Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com
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