Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Expansion in clinical trial eligibility requested by ASCO
Friends of Cancer and ASCO letter to the FDA
Key clinical point: ASCO and Friends of Cancer have submitted draft recommendations to the FDA for expanding cancer clinical trial participation.
Major finding: The organizations recommend addressing minimum age requirements, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.
Data source: Draft guidance produced by ASCO and Friends of Cancer Research and submitted to the FDA.
Disclosures: Individual members of the working groups were not listed and conflicts of interest were not disclosed.
Citation:
Friends of Cancer and ASCO letter to the FDA.
