FDA tells cancer trial sponsors

The Food and Drug Administration has moved from a general push for broader oncology enrollment to specific instructions on what sponsors should stop doing in trial protocols. In final guidance issued in July 2026, the agency said cancer-trial eligibility criteria should be tied to scientific and safety considerations, not copied from older studies without justification. (fda.gov) The documents focus on three recurring filters in oncology trials: performance status, washout periods and concomitant medications. FDA said those criteria should be reconsidered when they keep out patients who could safely participate. ### Which rules is the FDA telling sponsors to revisit? The FDA’s final guidance package covers performance status, washout periods with concomitant medications, and laboratory values. (fda.gov) The agency says eligibility criteria are meant to define the intended study population and reduce risk, but it also says those criteria can become unnecessarily restrictive when sponsors reuse standard language without a trial-specific basis. Performance status is one of the most common gates in oncology enrollment because it measures how well a patient is functioning day to day. The FDA said sponsors should consider broader enrollment where appropriate rather than defaulting to narrow cutoffs that favor only the fittest patients. Medical Daily reported that the final performance-status guidance added discussion of how broader criteria could affect retention and sample size. (fda.gov) ### Why are washout periods and medication rules getting singled out? Washout periods are the waiting intervals patients must complete after a prior therapy before entering a new study. The FDA said those time-based rules should be justified case by case, rather than imposed automatically. Applied Clinical Trials said the agency also told sponsors to accommodate necessary concomitant medications for comorbidities when possible, to avoid exclusions that are not tied to a clear safety concern. (fda.gov) Concomitant-medication restrictions matter because many cancer patients also take drugs for heart disease, diabetes, infection prevention or symptom control. The FDA’s guidance directs sponsors to distinguish between medications that create a real interaction risk and medications that are simply being barred by habit. (fda.gov) ### What is the agency trying to change in oncology trial design? The FDA’s Oncology Center of Excellence has framed the issue as one of unjustified exclusion. Applied Clinical Trials reported that the agency finalized the three guidances to expand participation by targeting restrictive criteria around performance status, washout periods and laboratory values. That report also cited a gap between cancer patients’ stated willingness to join trials and the much smaller share who actually enroll. (appliedclinicaltrialsonline.com) The broader FDA message in 2026 has been that trial design should track disease biology, investigational-drug risk and real-world patient populations more closely. Applied Clinical Trials, in a separate review of agency actions this year, said the FDA has been updating evidentiary expectations across development and trial methodology. (fda.gov) ### Does this change who the guidance applies to? The FDA labels the documents as guidance for industry, institutional review boards and clinical investigators. That means the immediate audience is the group that writes, reviews and oversees oncology protocols, rather than patients or treating physicians alone. The documents also state that guidance represents the agency’s current thinking and is not legally binding, though sponsors generally draft protocols with FDA expectations in mind. (appliedclinicaltrialsonline.com) July 27, 2026 is the issue date shown on the FDA page for the final laboratory-values guidance. The related performance-status and washout-period guidance documents are listed in the same eligibility-criteria series, indicating the agency has now converted that part of its 2024 draft effort into final recommendations. (appliedclinicaltrialsonline.com) ### What happens next for sponsors writing cancer protocols? Sponsors drafting oncology studies now have final FDA language to cite when they justify broader entry criteria or revise standard exclusions. Investigators and IRBs reviewing those studies have the same documents as a reference when they question narrow performance-status cutoffs, fixed washout windows or bans on needed background medications. The guidance documents are posted on the FDA’s guidance database and Oncology Center of Excellence guidance pages, where the agency also tracks related clinical-trial policy updates. (fda.gov 1) (fda.gov 2) (fda.gov 3)