ASCO Seeks More Aggressive Approach On Limiting Safety Data Collection

07 May 2012

The American Society of Clinical Oncology says FDA’s draft guidance on targeted safety data collection is too conservative and inconsistent with the agency’s recommendations from a 2001 guidance on cancer drug clinical trials.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.

Cancer drug clinical trial investigators and sponsors will continue to collect extensive amounts of safety data unless FDA’s new recommendations for targeted collection are consolidated and made consistent with the agency’s 2001 advice specific to oncology studies, the American Society of Clinical Oncology believes.

ASCO said FDA’s draft guidance on approaches to selectively collecting safety data in late-stage and post-marketing clinical trials does not...