Woodcock Says Patient Benefit Measures Are Biostatistics’ Next Frontier
Executive Summary
CDER director tells statisticians that trials have to be able to better answer patient benefit questions.
You may also be interested in...
FDA Sees Challenge In Distinguishing Lung Cancer Symptoms From Drug Side Effects
At the third patient-focused drug development meeting under PDUFA V, FDA staff urged patients to try to differentiate between symptoms caused by the underlying disease and those resulting from treatment, an important distinction when it comes to assessing the efficacy and safety of new drugs.
Biomarker Approvals At Pre-IND Stage Requested For Orphan Drugs
Updated draft white paper on expanding use of accelerated approval suggests FDA approve the use of biomarkers as surrogate endpoints in the pre-IND stage, which could enhance sponsors’ abilities to raise funds for trials and manufacturing.
Should FDA Be Forced To Consider Development Time And Cost?
Venture capitalist suggests the agency should keep both issues in mind when it orders a sponsor to conduct more trials or submit additional data in order to bring down the cost of drug development.