Dan Von Hoff discusses "The Complete Phase Ib"
Medelis has published a free new downloadable abstract, "The Complete Phase Ib: An Approach to Getting to Phase II Faster," an interview with renowned oncology investigator Daniel D. Von Hoff, M.D.
"The typical phase I approach is essentially serial drug development, which involves running multiple separate trials,” Dr. Von Hoff explains at the beginning of the interview. "Each site at each trial adds a layer of time, cost, and management oversight. What I call 'the complete phase Ib' is a simple solution that essentially tests the various drug combinations in one phase Ib with multiple arms run in parallel.
"For example, assume you have good preclinical data on a single agent that may be more effective in combination with another agent—for example, a monoclonal antibody plus gemcitabine (GEMZAR®)," he explains. "Most Chief Medical Officers anticipate that the pivotal clinical trials will be standard therapy with or without the new drug, and they prepare for that eventuality by conducting a phase I trial of the combination. Typically, this involves launching five, six, or sometimes more combination phase I trials. Each trial has to be negotiated and managed separately, and each must have its own protocol, adding layer upon layer of cost and effort.
"The strategy I'm suggesting eliminates all these separate serial trials because it puts the combinations into one phase Ib trial."
Dr. Von Hoff offers a detailed look at this approach and the many benefits to sponsors, patients, and investigators, including:
- 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
The abstract is the second in Medelis' "Peer Perspectives in Oncology" series. In the first issue, "Patient Safety in Clinical Trials," Dr. James Gourzis discusses recent issues in patient safety and the role of sponsors, CROs, IRBs, DMCs and the FDA in ensuring patient safety in future clinical trials.
You can download each of the interviews here. You’ll receive email notices when future issues are published as well.
