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
