Smarter, Better, Faster, Smaller: ASCO Pushes For Cancer Trial Improvements
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American Society of Clinical Oncology draft recommendations provide benchmarks for Phase III oncology drug trials, including a minimum 20% improvement in overall survival, with a higher bar for certain diseases.
FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.
Time Is Right For Patient-Centered Approach To Health Care Because Current Way “Is Not Working” – FDA’s Hamburg
FDA Commissioner Margaret Hamburg, along with AHRQ Director Carolyn Clancy, reflects on why there is a buzz around patient-centered health care and what patient engagement can mean to drug development and health care as a whole.