Dr. Bauer on Evolution of Phase I Trials

Todd Bauer, MD, associate director, Drug Development, principal investigator, Sarah Cannon Research Institute, discusses how phase I clinical trial programs are evolving and becoming more beneficial for patients with cancer.

Phase I trials have changed dramatically over the last 5 to 10 years. The previous goal of them, Bauer explains, was to determine safe doses of therapies for 15 to 30 patients. Now, pharmaceutical companies are having hundreds of patients enroll on phase I trials to have a proof-of-concept earlier in the drug development process.

This changes who are appropriate phase I patients and whether they are at the end of all possible treatment options or if such a trial would be a reasonable next step in their line of therapy.

Bauer adds that there are phase I studies of more than 20 expansion cohorts with 20 different groups of patients who are not heavily pretreated. The question is, he asks, how do clinicians get the right drugs to the right patients at the right time?