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Renowned Cancer Researcher Dan Von Hoff, M.D. Advocates for 'The Lost Opportunity in Phase I Oncology Trials'
Date:12/22/2008

ntrol. Rather than solely relying on the traditional data captured in normal phase I clinical trial protocols, he recommends measuring the tumor's "time to progression" on the current drug versus the tumor's "time to progression" on the patient's previous treatment. This data -- time to progression on each drug -- should be systematically tracked in the protocol so it becomes part of each patient's data bank.

"I have never seen a Chief Medical Officer plot time on a new drug versus the time on a just-prior therapy to build a story for raising money," Dr. Von Hoff continues. "This idea of using the patient as his or her own control is a lost concept in drug development. Dr. Bob Temple at the FDA, an icon in clinical trial design, calls it a lost art. He's referring to the ability to document changes in the natural history of a patient's tumor, and how this information can give you a sense of whether the drug will work."

"If you treat 30 patients and 30% stay on a new therapy for a longer time than the just-prior drug they had progressed on, then that would justify a deeper investment," he explains. "Patients' tumors grow at an inexorable, ever-quickening rate. If you find an agent that can taper that growth, then it is probably doing something and should be pursued."

In the abstract, Dr. Von Hoff answers many questions about this "lost art" in the phase I oncology clinical trial:

  • The distinction between "time on therapy" and "time to progression";
  • Why CMOs should place greater value on this data;
  • Why the practice isn't more common;
  • How to leverage the clinical investigator's observations and clinical judgment in the analysis of a treatment;
  • Why the subjective nature of this approach benefits pa
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Renowned Cancer Researcher Dan Von Hoff, M.D. Advocates for 'The Lost Opportunity in Phase I Oncology Trials'
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