FDA Is Making Clinical Trials More Inclusive: What Changed in 2025
Published April 6, 2026 · FDA guidance analysis
For decades, clinical trial eligibility criteria have excluded far more people than necessary. In December 2025, the FDA issued updated guidance that could fundamentally change who gets to participate — and who benefits from new treatments. Here is what changed, why it matters, and what it means if you or someone you care about has been turned away from a trial before.
Important: This is educational information, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
The Problem: Who Was Being Excluded
Before this guidance, it was common for clinical trials to automatically exclude patients based on criteria that had little to do with the treatment being tested. Studies have found that up to 85% of patients who express interest in a trial are screened out by eligibility criteria.
Some of the most common exclusions included:
- Prior cancers — even cancers diagnosed and treated years earlier with no recurrence
- Comorbidities — controlled diabetes, stable hypertension, mild kidney impairment, or other common conditions managed with medication
- HIV-positive status — regardless of viral suppression or immune function
- Age limits — upper age caps that excluded older adults even when the condition primarily affects older populations
- Organ function thresholds — liver or kidney function cutoffs that were more restrictive than clinical necessity required
- Brain metastases — even stable, treated brain metastases in oncology trials
The result: trials enrolled populations that did not reflect the patients who would actually use the treatment. A cancer drug tested only on patients under 65 with no comorbidities tells us very little about how it will work in the real world, where the median age of cancer diagnosis is 66 and most patients have at least one other health condition.
What the FDA Changed
The December 2025 guidance — building on earlier draft guidance from 2019 and 2020 — makes several concrete recommendations to trial sponsors:
| Old Practice | New FDA Guidance |
|---|---|
| Exclude patients with any prior cancer | Include patients with prior cancers that are cured or in long-term remission, unless scientifically justified to exclude |
| Exclude patients with stable comorbidities | Include patients with well-controlled conditions (diabetes, hypertension) unless the comorbidity directly impacts safety or endpoints |
| Exclude HIV-positive patients | Include patients with controlled HIV on antiretroviral therapy, particularly in oncology trials |
| Set restrictive age caps (e.g., 65 or 70) | Remove arbitrary upper age limits; eligibility should be based on physiological status, not chronological age |
| Use narrow organ function thresholds | Use clinically appropriate thresholds based on the treatment mechanism, not one-size-fits-all cutoffs |
| Exclude patients with treated brain metastases | Include patients with stable, treated brain metastases in oncology trials when appropriate |
The guidance also requires sponsors to provide a written justification for each exclusion criterion in their protocol. If a criterion is not necessary for safety or scientific validity, the FDA expects it to be removed.
Why This Matters for Patients
This guidance matters for three reasons:
More people can participate. With 7,801 trials currently recruiting across 2540 conditions, broader criteria mean more patients who need treatment options will be eligible to explore them. People who were turned away in the past may qualify for newly designed trials.
Better data for everyone. When trials enroll diverse populations that reflect real-world patients, the results are more meaningful. A treatment proven effective in a broad population is more trustworthy than one tested only in a narrow, highly selected group.
Faster enrollment means faster approvals. As we discussed in our analysis of why 80% of trials fail to enroll on time, restrictive eligibility is a major driver of enrollment delays. Broader criteria should help trials fill faster, which means promising treatments reach patients sooner.
What Has Not Changed
It is important to be clear about what this guidance does not do:
- It is not mandatory. The guidance is a recommendation, not a regulation. Sponsors are encouraged but not required to follow it. However, FDA reviewers will be looking for justification of exclusion criteria during the approval process.
- It does not apply retroactively. Trials that were already designed and approved under older criteria keep their current protocols. The guidance shapes new trials going forward.
- It does not lower safety standards. Every eligibility change must be scientifically justified. The goal is removing unnecessary exclusions, not reducing safety oversight.
What You Can Do Now
If you or a loved one has been turned away from a clinical trial in the past due to a prior cancer, comorbidity, age, or HIV status, consider searching again. New trials launching under this guidance are more likely to have inclusive criteria.
- Search for trials by condition on TrialFinder — we translate eligibility criteria into plain English so you can quickly see if you might qualify
- Ask your doctor to revisit clinical trial options, specifically mentioning the updated FDA eligibility guidance
- Do not assume you are excluded — read the actual criteria for new trials rather than going by past experience
Frequently Asked Questions
What did the FDA change about clinical trial eligibility in 2025?
In December 2025, the FDA issued updated guidance encouraging trial sponsors to remove eligibility criteria that are not scientifically necessary for safety. This includes reconsidering automatic exclusions for patients with prior cancers, stable comorbidities like controlled diabetes or hypertension, HIV-positive status, and organ impairment that is unrelated to the condition being studied.
Does the new FDA guidance mean I can now join a trial I was previously excluded from?
Not automatically. The guidance encourages sponsors to broaden criteria for new trials, but existing trials keep their current protocols. However, new trials launching after the guidance are more likely to have inclusive criteria. If you were excluded from a trial in the past, it is worth searching again — newer trials studying the same condition may have broader eligibility.
Why were clinical trial eligibility criteria so restrictive in the first place?
Historically, sponsors used narrow criteria to create a homogeneous study population, which simplifies data analysis and makes it easier to detect treatment effects. They also excluded patients with comorbidities out of an abundance of caution about safety. While well-intentioned, this approach meant trial results only reflected a narrow subset of patients, and many people who could benefit were shut out.
Will broader eligibility criteria make clinical trials less safe?
The FDA guidance specifically requires that any broadening of criteria must be justified by scientific evidence and must not compromise participant safety. Sponsors must still conduct thorough risk assessments. The goal is to remove criteria that were overly cautious or based on outdated assumptions — not to lower the safety bar.
About This Data
Analysis based on FDA guidance documents (Enhancing the Diversity of Clinical Trial Populations). Trial counts from ClinicalTrials.gov API v2. We track 7,801 recruiting trials across 2540 conditions. This is educational information — talk to your doctor about clinical trials. See our methodology.