The Priority Review

Clinical trials

Nearly 1 in 5 recruiting US trials for adults exclude people 80 and older by rule

The FDA's new draft guidance says early-phase solid tumor trials should in general set no upper age limit, and most already set none. A Priority Review analysis of 11,830 recruiting US trials finds the limits elsewhere: 41.8% of mental health trials and 38.3% of metabolic trials exclude people 80 and older.

By The Priority Review desk

Machine-summarized from the primary sources listed below; not independently reported. How we use automation

The FDA's November draft guidance for early-phase solid tumor trials says that, in general, "protocols should not impose upper age limitations," and that a proposed limit needs "adequate justification" (FDA draft guidance). Cancer trials already rarely set one. Of 595 recruiting phase 1 solid tumor trials for adults with a US site, 561 set no maximum age and 11 set one below 80.

Recruiting US trials for adults that exclude people 80 and older 0 10 20 30 40 50 Share of trials with a maximum age below 80 (%), by field All fields 2,181 of 11,830 18.4 Mental disorders 538 of 1,287 41.8 Nutritional and metabolic diseases 282 of 737 38.3 Nervous system diseases 479 of 1,841 26.0 Cardiovascular diseases 148 of 1,353 10.9 Cancers 204 of 4,169 4.9 Trials that enroll only adults and take no healthy volunteers, recruiting with a US site. From The Priority Review analysis of ClinicalTrials.gov records pulled November 14, 2026. Dashed line marks the All fields value. The Priority Review.
Recruiting US trials for adults that exclude people 80 and older 0 10 20 30 40 50 Share of trials with a maximum age below 80 (%), by field All fields 2,181 of 11,830 18.4 Mental disorders 538 of 1,287 41.8 Nutritional and metabolic diseases 282 of 737 38.3 Nervous system diseases 479 of 1,841 26.0 Cardiovascular diseases 148 of 1,353 10.9 Cancers 204 of 4,169 4.9 Trials that enroll only adults and take no healthy volunteers, recruiting with a US site. From The Priority Review analysis of ClinicalTrials.gov records pulled November 14, 2026. Dashed line marks the All fields value. The Priority Review.

The limits sit in other fields. We read the maximum-age field of every recruiting interventional study with at least one US location on ClinicalTrials.gov on November 14, 2026 (17,791 studies). Of those, 11,830 enroll only adults and take no healthy volunteers. The counts for every field and year are in the data and method file. Among the 11,830:

  • 8,058 (68.1%) set no maximum age
  • 2,181 (18.4%) set a maximum below 80, which leaves out everyone 80 and older
  • 1,221 (10.3%) set a maximum of 65 or lower

The most common limits are 75 (546 trials), 65 (517) and 80 (510).

Where the limits sit

The registry files each study under disease fields. The share of trials that exclude people 80 and older differs widely among them:

  • Mental disorders: 41.8% (538 of 1,287)
  • Nutritional and metabolic diseases: 38.3% (282 of 737)
  • Nervous system diseases: 26.0% (479 of 1,841)
  • Musculoskeletal diseases: 25.4% (99 of 390)
  • Cardiovascular diseases: 10.9% (148 of 1,353)
  • Cancers: 4.9% (204 of 4,169)

Single conditions show the pattern more sharply:

  • Schizophrenia: 55 of 66 trials stop at 65 or lower
  • Major depressive disorder: 76 of 111 exclude people 80 and older, and 53 stop at 65 or lower
  • Multiple sclerosis: 52 of 83 exclude people 80 and older
  • Obesity: 114 of 232
  • Type 2 diabetes: 44 of 156
  • Hypertension: 40 of 153

Conditions of later life go the other way. A maximum below 80 appears in 4 of 114 Alzheimer's disease trials, 1 of 65 atrial fibrillation trials, 10 of 142 heart failure trials, 16 of 125 Parkinson's disease trials and 33 of 244 stroke trials.

Age caps cluster in midlife conditions, not in conditions of later life

Recruiting US trials for adults: share with a maximum age below 80, by condition

MIDLIFE CONDITIONSMajor depressive disorderMajor depressive disorder: 76 of 111 (68.5%)68.5%76 of 111Multiple sclerosisMultiple sclerosis: 52 of 83 (62.7%)62.7%52 of 83ObesityObesity: 114 of 232 (49.1%)49.1%114 of 232Type 2 diabetesType 2 diabetes: 44 of 156 (28.2%)28.2%44 of 156HypertensionHypertension: 40 of 153 (26.1%)26.1%40 of 153CONDITIONS OF LATER LIFEStrokeStroke: 33 of 244 (13.5%)13.5%33 of 244Parkinson's diseaseParkinson's disease: 16 of 125 (12.8%)12.8%16 of 125Heart failureHeart failure: 10 of 142 (7.0%)7.0%10 of 142Alzheimer's diseaseAlzheimer's disease: 4 of 114 (3.5%)3.5%4 of 114Atrial fibrillationAtrial fibrillation: 1 of 65 (1.5%)1.5%1 of 650%20%40%60%80%
MIDLIFE CONDITIONSMajor depressive disorderMajor depressive disorder: 76 of 111 (68.5%)68.5%76 of 111Multiple sclerosisMultiple sclerosis: 52 of 83 (62.7%)62.7%52 of 83ObesityObesity: 114 of 232 (49.1%)49.1%114 of 232Type 2 diabetesType 2 diabetes: 44 of 156 (28.2%)28.2%44 of 156HypertensionHypertension: 40 of 153 (26.1%)26.1%40 of 153CONDITIONS OF LATER LIFEStrokeStroke: 33 of 244 (13.5%)13.5%33 of 244Parkinson's diseaseParkinson's disease: 16 of 125 (12.8%)12.8%16 of 125Heart failureHeart failure: 10 of 142 (7.0%)7.0%10 of 142Alzheimer's diseaseAlzheimer's disease: 4 of 114 (3.5%)3.5%4 of 114Atrial fibrillationAtrial fibrillation: 1 of 65 (1.5%)1.5%1 of 650%20%40%60%80%

Source: The Priority Review analysis of ClinicalTrials.gov, records pulled November 14, 2026. Trials enroll only adults and take no healthy volunteers.

Who pays makes little difference. Industry-sponsored trials exclude people 80 and older in 17.2% of cases (552 of 3,209), and trials with other lead sponsors in 18.9% (1,629 of 8,621). By phase, the share is 13.4% in phase 1, 16.2% in phase 3 and 22.8% in phase 4.

Seven years after the NIH policy

Age limits have been a policy target before. For grant applications due on or after January 25, 2019, the NIH requires that people of all ages "must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them" (NIH notice NOT-OD-18-116, archived copy).

To see whether limits fell, we grouped US trials for adults by the year they started, whatever their status now (112,681 studies, of which the adult patient trials are counted below). The share that exclude people 80 and older:

  • 2012: 24.4% (878 of 3,596)
  • 2018: 20.6%
  • 2019: 21.3%
  • 2020: 18.2%
  • 2023: 19.0%
  • 2024: 20.1%
  • 2025: 21.9% (1,071 of 4,896)
  • January through October 2026: 20.7%

The share fell before the policy and has stayed between 18.2% and 21.9% since. Trials that name the NIH as lead sponsor or collaborator show no decline either: 21.0% in 2019, 19.5% in 2024, 25.6% in 2025 and 20.0% in 2026.

The share of trials excluding people 80 and older fell before the NIH policy, then held

US trials for adult patients, by start year: share with a maximum age below 80

0%10%20%30%40%50%60%2012201420162018202020222024NIH policy applies,applications due fromJanuary 25, 2019Mental disorders, 2012: 55.0%Mental disorders, 2013: 56.5%Mental disorders, 2014: 53.0%Mental disorders, 2015: 48.7%Mental disorders, 2016: 53.4%Mental disorders, 2017: 46.7%Mental disorders, 2018: 45.1%Mental disorders, 2019: 45.0%Mental disorders, 2020: 41.6%Mental disorders, 2021: 39.9%Mental disorders, 2022: 39.2%Mental disorders, 2023: 37.6%Mental disorders, 2024: 42.1%Mental disorders, 2025: 40.0%Cancers, 2012: 7.4%Cancers, 2013: 7.1%Cancers, 2014: 7.6%Cancers, 2015: 7.9%Cancers, 2016: 7.3%Cancers, 2017: 4.6%Cancers, 2018: 5.6%Cancers, 2019: 5.3%Cancers, 2020: 4.5%Cancers, 2021: 5.0%Cancers, 2022: 5.3%Cancers, 2023: 3.9%Cancers, 2024: 4.2%Cancers, 2025: 5.5%All adult patient trials, 2012: 24.4%All adult patient trials, 2013: 25.9%All adult patient trials, 2014: 22.6%All adult patient trials, 2015: 22.7%All adult patient trials, 2016: 22.4%All adult patient trials, 2017: 21.5%All adult patient trials, 2018: 20.6%All adult patient trials, 2019: 21.3%All adult patient trials, 2020: 18.2%All adult patient trials, 2021: 20.8%All adult patient trials, 2022: 20.6%All adult patient trials, 2023: 19.0%All adult patient trials, 2024: 20.1%All adult patient trials, 2025: 21.9%55.0%24.4%7.4%40.0%Mental disorders21.9%All adultpatient trials5.5%Cancers
0%10%20%30%40%50%60%2012201620202025NIH policy,January 2019Mental disorders, 2012: 55.0%Mental disorders, 2013: 56.5%Mental disorders, 2014: 53.0%Mental disorders, 2015: 48.7%Mental disorders, 2016: 53.4%Mental disorders, 2017: 46.7%Mental disorders, 2018: 45.1%Mental disorders, 2019: 45.0%Mental disorders, 2020: 41.6%Mental disorders, 2021: 39.9%Mental disorders, 2022: 39.2%Mental disorders, 2023: 37.6%Mental disorders, 2024: 42.1%Mental disorders, 2025: 40.0%Cancers, 2012: 7.4%Cancers, 2013: 7.1%Cancers, 2014: 7.6%Cancers, 2015: 7.9%Cancers, 2016: 7.3%Cancers, 2017: 4.6%Cancers, 2018: 5.6%Cancers, 2019: 5.3%Cancers, 2020: 4.5%Cancers, 2021: 5.0%Cancers, 2022: 5.3%Cancers, 2023: 3.9%Cancers, 2024: 4.2%Cancers, 2025: 5.5%All adult patient trials, 2012: 24.4%All adult patient trials, 2013: 25.9%All adult patient trials, 2014: 22.6%All adult patient trials, 2015: 22.7%All adult patient trials, 2016: 22.4%All adult patient trials, 2017: 21.5%All adult patient trials, 2018: 20.6%All adult patient trials, 2019: 21.3%All adult patient trials, 2020: 18.2%All adult patient trials, 2021: 20.8%All adult patient trials, 2022: 20.6%All adult patient trials, 2023: 19.0%All adult patient trials, 2024: 20.1%All adult patient trials, 2025: 21.9%55.0%24.4%7.4%40.0%Mental disorders21.9%All adultpatient trials5.5%Cancers

Trials that name the NIH as lead sponsor or collaborator: 22.9% in 2012, 21.0% in 2019, 25.6% in 2025.

Source: The Priority Review analysis of ClinicalTrials.gov, records pulled November 14, 2026. Start years 2012 through 2025, any status today.

The registry's NIH label does not capture every trial the NIH funds, and the policy permits a limit that comes with a justification, so these figures show the trend and are no test of compliance.

One field we tracked by start year did move. Among trials filed under mental disorders, 55.0% of those started in 2012 excluded people 80 and older, against 40.0% of those started in 2025.

What it means at a site

A maximum age is an eligibility criterion that needs no chart review: a birth date settles it. In major depression and multiple sclerosis trials, that one line rules out patients 80 and older in most studies, and patients past 65 in more than 4 in 10. The FDA draft asks cancer sponsors to justify a limit. Under the NIH policy, a grant recipient that excludes people by age "must provide an acceptable justification for the exclusion".

What remains uncertain

The registry field records the limit and gives no reason for it, so this analysis does not judge whether any single limit is justified. Other eligibility criteria, such as organ function or other illnesses, also exclude older adults, and the maximum-age field does not capture them (data and method file).

Sources