The real action today is in phase II dose-finding trials and even in phase I trials for safety.
Phoenix AZ (PRWEB) February 2, 2010
Adaptive trial design is a hot topic in the drug development community thanks to their complexity and substantial potential benefits for sponsors and patients. In Medelis' new issue of Peer Perspectives in Oncology, Dr. Ranganath Nayak of Cytel Inc. discusses the rapid evolution of the adaptive trial model and the latest thinking about its application in phase I and phase II clinical studies.
"When the industry started seriously talking about adaptive trial design a few years back, the focus was on phase III and seamless phase II/III trials," explains Medelis CEO Bob Bosserman. "But it turns out that the real action today is in phase II dose-finding trials and even in phase I trials for safety.
"Cytel has designed more adaptive trials for industry sponsors than any other service provider and in virtually every therapeutic area," he continued. "Sponsors should carefully consider the adaptive model for the many commercial, ethical, and budgetary benefits that the paper explores."
In the interview, Dr. Nayak, the CEO of Cytel, explains why adaptive trial design is gaining so much momentum in early stage studies. "First, adaptive trials are most helpful when you do not know enough at the beginning of a trial to design it with confidence," he says. "This is much more likely to be true in phases I and II than in phase III.
"Second, the best way to make expensive phase III trials more successful is to do more thorough work in phases I and II," he continues. "Getting the dose right through well-designed phase I and phase II trials is the best way to maximize success in phase III, which then leads to a higher rate of NDAs.
Dr. Nayak offers insight and expertise on a variety of issues surrounding adaptive trial design, including:
- Commercial, ethical, and budgetary benefits of the adaptive trial model;
- Statistical and data issues;
- Changing to the adaptive model across multiple sites;
- Safety issues to consider;
- Budgeting for an adaptive trial;
- Dealing with independent decision-making bodies;
- Patient consent and communication issues;
- Medical supply logistics;
- Other best practices and planning issues.
The abstract is free and available for download at Medelis.com.
ABOUT "INSIDER ABSTRACTS"
This abstract is the sixth in Medelis' complimentary "Peer Perspectives in Oncology" Q&A series, which brings together respected researchers to discuss issues that face Chief Medical Officers today: rising costs, optimum patient accrual, targeted therapeutics, patient safety, FDA regulations, efficacy, budgets, and timelines. Previous issues include "Context of Vulnerability," "The Lost Opportunity in Phase I Oncology Trials," "Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster," "The Complete Phase IB," and "Patient Safety in Clinical Trials."
These free abstracts are available for download at http://www.medelis.com.
Cytel, Inc., is a leading provider of clinical trial services and specialized statistical software for the biopharmaceutical, medical device, academic, and government research markets. Cytel has designed more adaptive trials for industry sponsors than any other service provider and in virtually every therapeutic area, helping pharmaceutical and biotech companies raise trial success rates while reducing development time and costs. The methods developed at Cytel are validated and published, with their authors regularly invited speakers on a range of adaptive topics including advances in Bayesian and Frequentist methods, adaptive trial modeling and simulation, key operational areas such as flexible randomization, forecasting of recruitment, and drug supply management. Cytel experts also periodically provide training to FDA biostatisticians on the use of Cytel's software.
Medelis, Inc. is an oncology contract research organization providing a total solution for biotechnology and pharmaceutical companies seeking rapid drug development and approval. Medelis' medical founders, team physicians and clinical trial management physicians, including Dan Von Hoff, James Gourzis and Michael Gordon, are internationally-recognized oncology thought and opinion leaders who understand the future of personalized medicine and threshold of credibility trials.
Medelis is privately-held with US locations in Phoenix (headquarters), Nashville, Boston and Reno. Medelis Europe is headquartered in Port Vendres, France.