FDA Suggests New Flexibility for Blinding Cancer Trials

Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday.

Using placebos in double-blind, randomized trials is a traditional way to protect against bias, but it also raises “both practical and ethical concerns,” the FDA says.  For one thing, giving a mere placebo to someone who is getting sicker could be perceived as tantamount to denying them care. For another, many experimental drugs may have toxic side effects and it can be dangerous to keep patients and/or researchers in the dark about whether the med or disease is to blame for symptoms.

In an effort to assuage concerns, many recent cancer trials take an open-label approach where patients are given an already-approved treatment instead of placebos to compare against the experimental one. Other trials use an add-on approach—all patients are given standard treatment plus either a placebo or an experimental treatment.