Performance status is the scale oncologists use to describe how well a patient can function - whether they are up and about, or in a chair most of the day, or in bed. For decades it has also been a gate. Trials routinely excluded the patients who scored worst.
The FDA filed three final guidances today recommending that stop [1].
The lead document, 'Cancer Clinical Trial Eligibility Criteria: Performance Status,' recommends 'expanding eligibility criteria to include patients with a wider range of performance status' [1]. Two companions address the other common gates: washout periods and concomitant medications, and laboratory values [1].
The agency's stated reasoning is the part worth quoting, because it is an argument about evidence rather than access alone. Overly restrictive eligibility criteria impede recruitment, limit trial access, and produce results that are not representative of the population that ultimately uses the approved drug [1].
That last clause is the one that matters to anyone who has ever been handed a treatment and told what the trial showed. If the trial enrolled only the healthiest patients, the trial describes the healthiest patients.
The performance-status guidance finalises a draft issued in April 2024 [1] - a little over two years from proposal to final, which for guidance of this kind is not slow.
Guidance is not binding law; it tells industry what the agency expects to see. What it changes is the default, and the default here has been exclusion.
