Viewing posts categorised under: Phase-ii

Adaptive Trial Design for Phase I, Phase II

Adaptive trial design is a hot issue in the drug development community. Adaptive conferences and web seminars abound, and suddenly, every consultant or vendor to the industry has become an adaptive expert. The FDA and EMEA are also much more receptive to adaptive trials than they were a few years ago. However, the picture is a shade different from what the industry had expected. Originally, much of the focus was on adaptive phase III trials as well as on seamless phase II/III trials. Those are, indeed, successfully being implemented today. But the real action is in phase II dose-finding trials and even in phase I trials for safety.

“Context of vulnerability” and its role in targeted drug development

Renowned cancer researcher Dr. Daniel Von Hoff and his team at TGen are fervent believers in a new approach to developing novel therapies for patients with pancreatic cancer. Their rationale has been dubbed “context of vulnerability,” and it is a powerful new drug development paradigm that’s generating impressive results.

Dan Von Hoff discusses “The Complete Phase Ib”

Renowned oncology researcher Dr. Daniel Von Hoff, a member of President Bush's National Cancer Advisory Board, provides an in-depth look at “The Complete Phase Ib,” an oncology clinical trial design that creates rapid accrual rates, substantial economies of scale, significant time savings, enthusiasm from investigators and patients, and improved therapeutic benefits. The complete interview is available for download from Medelis, an oncology contract research organization providing complete oncology clinical trial design, management and execution.