The FDA issued five guidance documents that the agency hopes will help sponsors get a handle on increasingly complex cancer trials.
The guidances contain recommendations that would allow traditionally more vulnerable patients—from children to HIV patients—access to experimental medicines. The guidances underline that trials are increasingly becoming front-line care for many patients.
“The overall purpose of this series of draft guidances for Cancer Clinical Trial Eligibility Criteria is to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for the treatment of cancer,” the agency says. “Including patients with the conditions covered by the guidances will allow for trial results that better represent the patient population that will use the drug or biological product.”