In joint comments submitted on June 25, ASCO and Friends expressed appreciation for the FDA’s three new guidance documents, noting the continuous work in advocating for broad and inclusive eligibility criteria in clinical trials to improve the relevance of clinical trial results to the broader patient population.

The two organizations were especially pleased that the FDA guidance closely followed recommendations that they had jointly published in 2021 as a series of articles in Clinical Cancer Research, a journal of the American Association for Cancer Research. Those recommendations called for further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients.

Key Takeaways From the Comments

Guidance Document on Performance Status: ASCO and Friends noted their support for this guidance, highlighting the importance of patients with low-functioning performance status to ensure that evidence from clinical trials has “greater applicability to patients with cancer, and the agency’s suggestion that sponsors should incorporate exploratory cohorts early in the development process and use early-stopping rules in response to safety concerns.”

Guidance Document on Laboratory Values: ASCO and Friends agree with the guidance’s consideration around the need for careful selection of the target population and called the approach “essential for developing treatments in a way that accurately reflects use in real-world patient populations.” They also commended the guidance’s focus on ensuring that laboratory value–based criteria are used only when necessary to protect patient safety and enhance the scientific validity of trials by ensuring that the results are applicable to a wider patient population.

Guidance on Washout Periods and Concomitant Medications: ASCO and Friends were pleased that this guidance states that washout periods should be based on relevant clinical and laboratory parameters associated with the preceding therapy. In the joint comments, there was agreement that time-based washout periods should not be used unless scientifically justified, but the organizations noted the guidance should also consider situations where concomitant medications may reduce the activity of the investigational drug. They agreed with the FDA that sponsors should evaluate drug-drug interactions early in development and incorporate accumulated pharmacologic information as soon as possible.

ASCO and Friends concluded their joint comments by commending the FDA for broadening eligibility criteria through the release of the draft guidance documents, noting they hope it “focuses attention on these important issues and prompts sponsors to modify their trial design to make trials more inclusive and representative of the broader patient population.”