Applied Clinical Trials-06-20-2006

Dr. Sanjay Gupta, senior medical correspondent for CNN, practicing neurosurgeon, and assistant professor of neurosurgery, delivered the Keynote Address at the 42nd DIA Annual Meeting on Monday morning.

DIA President, Theresa Kane Musser, Executive Director, Development Operations, Rigel Pharmaceuticals, presented the awards

In the afternoon, ACT columnist Ken Getz, MS, MBA, chaired the session: "Prevention of Fraud and Noncompliance in Clinical Research." Ken was joined by speakers David Cocchetto, PhD, RPh, of GlaxoSmithKline, and Dara Katcher, JD, of the Washington, DC law firm, Hyman, Phelps & McNamara.

On Monday, Peter DiBiaso, MHA, director of clinical trial recruitment services for Pfizer, chaired the session: "Championing the Patient Perspective in Clinical Study Recruitment and Retention: The Role of Sponsor, CRO, and Vendor in Successful Strategy Development."

Representatives of FDA, EMEA and industry discussed their pilot program to provide parallel scientific advice to sponsors developing new drugs. The process aims to resolve critical clinical and safety issues early in the research process to avoid duplicative testing and regulatory delay.

In an afternoon session examining innovations in the development of anticancer medicines, speakers from the research, therapeutic, regulatory and industry perspectives discussed "Changing the Paradigm: Innovative Oncology Drug Clinical Development Programs in the Age of the Critical Path and Personalized Medicine."

In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.

Multiple partnerships formed over past year using SAS Drug Development, SAS Enterprise Intelligence Platform

Solution addresses biomarkers, incorporates molecular information