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

Publish date:: August 17, 2018

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Data source: Draft guidance produced by ASCO and Friends of Cancer Research and submitted to the FDA.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.

Read the article.

Citation:

Friends of Cancer and ASCO letter to the FDA.

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Expansion in clinical trial eligibility requested by ASCO, Friends of Cancer and ASCO letter to the FDA