The double-blind, randomized, parallel group design of clinical trials is so entrenched with well-established processes and systems in the industry that to even consider a change in structure may seem like an uphill battle.
But many in the pharmaceutical industry — from pharmaceutical companies, contract research organizations, suppliers and service providers, and regulators — are willing to re-evaluate their drug-development processes to make midcourse trial adjustments. They are discussing the challenges and opportunities and working to build the tools and infrastructure to incorporate more flexible, adaptive trial designs. Adaptive designs appear to hold promise for more efficient drug development by allowing sponsors to adjust the trial as results become known…
The Systems That Enable An Adaptive Approach
Sound Bites from the Field
Phillip L. Banks, MS, FRS, Senior Director of Biostatistics and Information Technology of Prologue Research Inc., Columbus, Ohio. For more information, visit procro.com.
Hugh Levaux,VP of Product Strategy of Medidata Solutions Worldwide, New York. For more information, visit mdsol.com.
Mark Waxman, Partner at Foley & Lardner LLP, Boston For more information, visit foley.com.
Experts on this Topic
Sylva Collins, Ph.D. VP of Global Biometrics, Kendle, Cincinnati; Kendle is among the world’s leading global clinical research organizations and a provider of Phase II to Phase IV clinical development services worldwide. For more information, visit kendle.com.
Michael Krams, Ph.D. Assistant VP, Adaptive Trials, and Head of the Learn and Confirm Adaptive Trials Team, Wyeth Research & Development, Collegeville, Pa.; Wyeth is a research-driven pharmaceutical and healthcare products company. For more information, visit wyeth.com.
Christine Lys, M.S. Director, Business Development, etrials Worldwide Inc., Morrisville, N.C.; etrials provides e-clinical software and services to pharmaceutical, biotechnology, medical-device, and contract research organizations. For more information, visit etrials.com.
Christian Marcazzo. Senior Director of Life Sciences, Spotfire Inc., Somerville, Mass.; Spotfire provides enterprise analytics software for next-generation business intelligence. For more information, visit spotfire.com.
George Q. Mills, Ph.D. VP, Medical Imaging Consulting for Perceptive Informatics at Parexel International Corp., Waltham, Mass.; Parexel is a leading global bio/pharmaceutical services organization that helps clients expedite time-to-market through its development and launch services. For more information, visit parexel.com.
Robert T. O’Neill, Ph.D. Director, Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.; The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. For more information, visit fda.gov.
Jerald S. Schindler, Dr. P.H. VP, Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co. Inc., Whitehouse Station, N.J.; Merck is a global research-driven pharmaceutical company. For more information, visit merck.com.
Brian Schwartz, M.D. Senior VP, Medical and Regulatory, and Chief Medical Officer, Ziopharm Oncology Inc., New York; Ziopharm Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. For more information, visit ziopharm.com.