Trials of oncology treatments should extend their inclusion criteria to encompass more vulnerable patient populations, the FDA says in four guidances it finalized last week.

Released as drafts in March 2019, the four guidances advise sponsors on inclusion criteria for pediatric patients, patients with brain metastases, those with organ dysfunction or other prior malignancies, and HIV and hepatitis patients (CenterWatch Weekly, March 18, 2019). The final documents are virtually unchanged from their drafts.

In addition to addressing pediatric inclusion in cancer trials, the FDA released a draft guidance in late June to help sponsors design pediatric trials of anti-infective drugs. Sponsors may extrapolate efficacy results from adult studies to use in pediatric studies, the draft guidance says, but still will need to gather safety and pharmacokinetics data to demonstrate that the proposed dosing regimen produces similar exposures in children and adults. Comments on the draft guidance are due by Aug. 29.

To read the guidance on inclusion of HIV and hepatitis patients in cancer trials, click here: https://bit.ly/2AMuQsm.

To read the guidance on including patients with organ dysfunction, click here: https://bit.ly/2ZWLUV7.

To read the guidance on brain metastases, click here: https://bit.ly/2DpblXK.

To read the guidance on including pediatric patients in cancer trials, click here: https://bit.ly/38VWikh.

To read the draft guidance on pediatric trials of anti-infective drugs, click here: https://bit.ly/3iTTdFZ.