ASCO Seeks More Aggressive Approach On Limiting Safety Data Collection
The American Society of Clinical Oncology says FDA’s draft guidance on targeted safety data collection is too conservative and inconsistent with the agency’s recommendations from a 2001 guidance on cancer drug clinical trials. ASCO requests the two guidances be harmonized to eliminate the potential for confusion among sponsors and clinical trial investigators.
You may also be interested in...
The Oncologic Drugs Advisory Committee’s July 24 meeting to discuss the merits of independent radiological review of progression assessments in a pre-specified subgroup of patients, instead of 100% of all assessments, comes three years after the agency signaled it was open to considering such an approach.
FDA’s proposal to limit collection of certain safety data in late-stage and post-marketing clinical trials will only reduce the burden on sponsors, investigators and patients if drug regulators across the globe agree to the concept, pharmaceutical manufacturers say.
A recent draft guidance reflects the agency’s views on when it may be appropriate to reduce the amount of safety information collected in late-stage and post-marketing studies and what types of data may be eligible for limited or non-collection.