Peer Perspectives in Oncology
In Peer Perspectives in Oncology, Medelis brings together some of the industry’s most respected researchers to talk about the issues facing Chief Medical Officers today. They’re issues we all face on a daily basis: Rising costs. Optimum patient accrual. Targeted therapeutics. Patient safety. FDA regulations. Efficacy. Budgets. Timelines.
In this Q&A series, we’ll discuss these challenges with leading experts who deliver practical, frontline insights gleaned from years of experience bringing new drugs to market.
These abstracts are free; to download one or more issues, please fill out the form at right.
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The Complete Phase Ib: An Approach for Getting to Phase II Faster
Published July 9, 2008
In this interview, renowned oncology researcher Daniel D. Von Hoff, M.D. discusses “the complete phase Ib,” a trial design that streamlines phase I by testing various drug combinations in one trial with multiple arms running in parallel. This structure creates rapid accrual rates, substantial economies of scale and significant time savings for sponsors versus the traditional sequential approach. It also garners enthusiasm from investigators and patients, who ultimately gain greater potential for improved therapeutic benefits and care.
Dr. Von Hoff provides insight and details on a variety of questions about this approach:
- "The complete phase Ib" concept
- Patient accrual and treatment benefits
- How the approach can "rescue" patients
- Dosing strategies
- Logistical considerations
- Cost and timing considerations
- Effects on phase II studies
- Reactions from the FDA, investigators, sponsors and patients
To download the interview, please fill out the form at right.
Patient Safety in Clinical Trials:
A Q&A with James T. Gourzis, M.D., Ph.D.
Published March 25, 2008
Clinical investigators are responsible for protecting the rights, safety, and welfare of subjects under their care during a clinical trial (21 CFR 312.60 and 812.100). In many trials, the sponsor delegates some decisions regarding trial design and conduct to an entity such as a steering committee or contract research organization (CRO).
Patient safety has always been the industry’s focus during clinical trials. However, a recent spate of well-publicized patient safety issues have increased public scrutiny and the industry’s desire to improve study quality, resulting in larger, longer, more expensive trials.
In this issue of Peer Perspectives in Oncology, James T. Gourzis, M.D., Ph.D., talks with Medelis about issues affecting patient safety:
- Factors that have launched patient safety to the forefront of public scrutiny, including the effects of increased reporting requirements
- What to look for when evaluating CRO excellence and commitment to patient safety
- Unique safety considerations in oncology trials and the ramifications of the rare toxicity
- Optimizing the role of the Data Monitoring Committee
- Budget decisions that support patient safety
- The evolution and future of FDA regulations
Read the abstract online, or you can download it as a PDF -- just fill out the form on this page and we'll email you a link.