Indication Matters: Study Shows Trial Characteristics Of Approved Drugs Vary Widely Across Diseases
FDA data requirements supporting novel drug approvals vary widely, depending on therapeutic area, with cancer drugs given greatest leniency, suggesting products may need a clinical trial “quality grade,” according to an analysis published in the Journal of the American Medical Association. Another study shows cancer treatments are most likely to get approved on the first try.
You may also be interested in...
Systematizing Patient Views Unlikely, FDA’s Temple Says
Stakeholders want an objective way for patient views to be considered in a benefit-risk decision, but FDA’s Bob Temple says weighing patient decisions depends on imprecise things.
R&D Productivity Still Lags: Study Shows Success Rates May Have Been Overestimated
Large study tracking drug indications pursued by more than 800 companies over almost a decade finds that only one in 10 wound up getting approved. By therapeutic area, Phase III success rates were lowest in cancer and cardiovascular medicine, and highest in diabetes, infectious and autoimmune disease.
Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows
Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.