“While some of these barriers, such as the lack of statistical tools, have been reduced over time, other barriers persist, including education and change management,” said DIA Program Chairperson Brenda Gaydos.
Horsham, PA (PRWEB) November 16, 2012
In 2010, the Food and Drug Administration recognized these potential benefits in Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics. Surveys of adaptive trials designed or conducted in 2008 and 2011 with pharmaceutical companies and contract research organizations (CROs) have identified barriers to the implementation of these designs.
“While some of these barriers, such as the lack of statistical tools, have been reduced over time, other barriers persist, including education and change management,” said DIA Program Chairperson Brenda Gaydos, Research Fellow, Advanced Analytics, Head of Clinical Trial Optimization, Eli Lilly and Company. “This conference provides a forum to examine remaining barriers and discuss solutions to the use of adaptive design approaches in clinical trials.”
Featured sessions will include:
--Where Are We Today With Adaptive Designs?, moderated by Alex Dmitrienko,Executive Director, Center for Statistics in Drug Development(Quintiles), and Annie Lin, Visiting Scientist, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration
--Joint Session 4: Role of DMC in Adaptive Designs, moderated by Lisa M. LaVange, Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration
--Adaptive Treatment or Population Selection in Confirmatory Setting, moderated by Jeff Maca, Senior Director, Center for Statistics in Drug Development (Quintiles)
Register for the DIA Adaptive Designs in Clinical Trials: Overcoming Persistent Barriers conference.
DIA is a neutral, global, professional and member-driven association of nearly 18,000 professionals involved in the discovery, development and lifecycle management of pharmaceuticals, biotechnology, medical devices and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies and services to improve health and well-being worldwide. Headquarters are in Horsham, Pa., USA, with offices in Basel, Switzerland; Tokyo, Japan; Mumbai, India; Beijing, China; Washington, D.C.; and Latin America. Visit our website at http://www.diahome.org; follow DIA on Facebook, Twitter (#druginfoassn), LinkedIn, Flickr and YouTube