The Priority Review: data and method
Upper age limits in recruiting US clinical trials, November 2026
Prepared November 14, 2026. Editor: Nick Bostic. Questions and corrections: news@thepriorityreview.com

SUMMARY
Nearly 1 in 5 recruiting US trials for adults exclude people 80 and older by rule. Industry-sponsored trials and trials with other lead sponsors differ little. The limits cluster in mental health and metabolic research; cancer trials rarely set one.

SOURCE
ClinicalTrials.gov API version 2, pulled November 14, 2026.
Pull 1: recruiting interventional studies with at least one United States location: 17,791 studies.
Pull 2: interventional studies with at least one United States location and a start date from January 1, 2012 through October 31, 2026, any status: 112,681 studies.
Pull 3: recruiting studies that list phase 1, match the condition search "solid tumor" and have a United States location: 648 studies, of which 595 enroll only adults and take no healthy volunteers.

METHOD
Adult patient trials are studies whose minimum age is 18 years or older and whose record says healthy volunteers are not accepted. Pull 1 holds 11,830 of them. The maximum age is the structured Maximum Age field. "Excludes people 80 and older" means a maximum age below 80 years. "65 or lower" means a maximum age of 65 years or less. Fields are the Medical Subject Headings terms and ancestor terms the registry assigns to each study's conditions; a study can sit in more than one field. Cancers means the term Neoplasms. For the start-year series only ancestor terms were pulled. Industry means the lead sponsor class is INDUSTRY. NIH-linked means the lead sponsor or a collaborator has the class NIH.

RECRUITING ADULT PATIENT TRIALS WITH A US SITE
group | trials | no maximum age | maximum below 80 | maximum 65 or lower
All fields | 11,830 | 8,058 (68.1%) | 2,181 (18.4%) | 1,221 (10.3%)
Industry lead sponsor | 3,209 | 2,279 (71.0%) | 552 (17.2%) | 216 (6.7%)
Other lead sponsors | 8,621 | 5,779 (67.0%) | 1,629 (18.9%) | 1,005 (11.7%)
NIH as lead sponsor (collaborators were not pulled for this table) | 268 | 119 (44.4%) | 50 (18.7%) | 22 (8.2%)
Phase 1 | 2,367 | 1,839 (77.7%) | 316 (13.4%) | 141 (6.0%)
Phase 2 | 3,626 | 2,617 (72.2%) | 586 (16.2%) | 255 (7.0%)
Phase 3 | 1,197 | 844 (70.5%) | 194 (16.2%) | 82 (6.9%)
Phase 4 | 566 | 335 (59.2%) | 129 (22.8%) | 89 (15.7%)
No phase (devices, behavioral and other) | 4,908 | 3,078 (62.7%) | 1,046 (21.3%) | 678 (13.8%)
Phase 1 solid tumor (pull 3) | 595 | 561 (94.3%) | 11 (1.8%) | 0 (0.0%)
Field: Cancers (Neoplasms) | 4,169 | 3,627 (87.0%) | 204 (4.9%) | 83 (2.0%)
Field: Cardiovascular Diseases | 1,353 | 890 (65.8%) | 148 (10.9%) | 59 (4.4%)
Field: Nervous System Diseases | 1,841 | 928 (50.4%) | 479 (26.0%) | 255 (13.9%)
Field: Mental Disorders | 1,287 | 568 (44.1%) | 538 (41.8%) | 409 (31.8%)
Field: Respiratory Tract Diseases | 1,049 | 808 (77.0%) | 109 (10.4%) | 35 (3.3%)
Field: Musculoskeletal Diseases | 390 | 212 (54.4%) | 99 (25.4%) | 44 (11.3%)
Field: Nutritional and Metabolic Diseases | 737 | 351 (47.6%) | 282 (38.3%) | 154 (20.9%)
Field: Digestive System Diseases | 1,069 | 821 (76.8%) | 137 (12.8%) | 37 (3.5%)
Field: Infections | 366 | 262 (71.6%) | 57 (15.6%) | 30 (8.2%)
Field: Immune System Diseases | 1,153 | 800 (69.4%) | 249 (21.6%) | 112 (9.7%)
Field: Skin and Connective Tissue Diseases | 1,071 | 847 (79.1%) | 126 (11.8%) | 45 (4.2%)
Field: Endocrine System Diseases | 860 | 615 (71.5%) | 160 (18.6%) | 78 (9.1%)
Field: Urogenital Diseases | 1,428 | 1,091 (76.4%) | 188 (13.2%) | 116 (8.1%)
Field: Eye Diseases | 254 | 189 (74.4%) | 33 (13.0%) | 17 (6.7%)
Field: Hemic and Lymphatic Diseases | 1,037 | 870 (83.9%) | 97 (9.4%) | 38 (3.7%)
Condition: Heart Failure | 142 | 98 (69.0%) | 10 (7.0%) | 4 (2.8%)
Condition: Alzheimer Disease | 114 | 45 (39.5%) | 4 (3.5%) | 1 (0.9%)
Condition: Parkinson Disease | 125 | 44 (35.2%) | 16 (12.8%) | 2 (1.6%)
Condition: Stroke | 244 | 104 (42.6%) | 33 (13.5%) | 8 (3.3%)
Condition: Pulmonary Disease, Chronic Obstructive | 67 | 32 (47.8%) | 5 (7.5%) | 1 (1.5%)
Condition: Osteoarthritis | 95 | 50 (52.6%) | 22 (23.2%) | 6 (6.3%)
Condition: Diabetes Mellitus, Type 2 | 156 | 90 (57.7%) | 44 (28.2%) | 13 (8.3%)
Condition: Atrial Fibrillation | 65 | 45 (69.2%) | 1 (1.5%) | 0 (0.0%)
Condition: Hypertension | 153 | 85 (55.6%) | 40 (26.1%) | 24 (15.7%)
Condition: Depressive Disorder, Major | 111 | 24 (21.6%) | 76 (68.5%) | 53 (47.7%)
Condition: Depression | 243 | 106 (43.6%) | 103 (42.4%) | 76 (31.3%)
Condition: Obesity | 232 | 100 (43.1%) | 114 (49.1%) | 74 (31.9%)
Condition: Multiple Sclerosis | 83 | 20 (24.1%) | 52 (62.7%) | 35 (42.2%)
Condition: Asthma | 33 | 12 (36.4%) | 19 (57.6%) | 6 (18.2%)
Condition: Schizophrenia | 66 | 6 (9.1%) | 59 (89.4%) | 55 (83.3%)
Condition: Kidney Diseases | 336 | 233 (69.3%) | 57 (17.0%) | 14 (4.2%)
Condition: Chronic Pain | 131 | 81 (61.8%) | 30 (22.9%) | 17 (13.0%)
Condition: Arthritis, Rheumatoid | 47 | 27 (57.4%) | 16 (34.0%) | 3 (6.4%)
Condition: Substance-Related Disorders | 313 | 163 (52.1%) | 129 (41.2%) | 92 (29.4%)
Condition: Anxiety Disorders | 174 | 79 (45.4%) | 78 (44.8%) | 65 (37.4%)
Condition: Sleep Wake Disorders | 182 | 93 (51.1%) | 73 (40.1%) | 47 (25.8%)
Condition: Bipolar Disorder | 34 | 6 (17.6%) | 26 (76.5%) | 21 (61.8%)
Condition: Stress Disorders, Post-Traumatic | 171 | 93 (54.4%) | 69 (40.4%) | 49 (28.7%)
Most common maximum ages (years: trials): 75: 546, 65: 517, 80: 510, 70: 308, 85: 303, 90: 180, 99: 152, 60: 146, 100: 140, 89: 115, 55: 103, 50: 96

ADULT PATIENT TRIALS WITH A US SITE BY START YEAR (any status), share with a maximum age below 80
year | all trials | NIH-linked | Mental disorders | Cancers (Neoplasms) | industry
2012 | 878 of 3,596 (24.4%) | 131 of 571 (22.9%) | 193 of 351 (55.0%) | 73 of 993 (7.4%) | 318 of 1,359 (23.4%)
2013 | 986 of 3,805 (25.9%) | 136 of 541 (25.1%) | 191 of 338 (56.5%) | 72 of 1,007 (7.1%) | 332 of 1,349 (24.6%)
2014 | 893 of 3,947 (22.6%) | 134 of 603 (22.2%) | 185 of 349 (53.0%) | 83 of 1,091 (7.6%) | 303 of 1,439 (21.1%)
2015 | 934 of 4,110 (22.7%) | 129 of 576 (22.4%) | 182 of 374 (48.7%) | 94 of 1,189 (7.9%) | 360 of 1,553 (23.2%)
2016 | 924 of 4,133 (22.4%) | 131 of 579 (22.6%) | 205 of 384 (53.4%) | 87 of 1,185 (7.3%) | 321 of 1,430 (22.4%)
2017 | 1,010 of 4,698 (21.5%) | 141 of 666 (21.2%) | 185 of 396 (46.7%) | 61 of 1,336 (4.6%) | 296 of 1,518 (19.5%)
2018 | 999 of 4,861 (20.6%) | 147 of 702 (20.9%) | 205 of 455 (45.1%) | 74 of 1,310 (5.6%) | 351 of 1,677 (20.9%)
2019 | 1,028 of 4,819 (21.3%) | 169 of 805 (21.0%) | 232 of 516 (45.0%) | 68 of 1,292 (5.3%) | 342 of 1,577 (21.7%)
2020 | 856 of 4,715 (18.2%) | 148 of 746 (19.8%) | 180 of 433 (41.6%) | 56 of 1,241 (4.5%) | 298 of 1,641 (18.2%)
2021 | 1,103 of 5,298 (20.8%) | 199 of 878 (22.7%) | 236 of 592 (39.9%) | 68 of 1,364 (5.0%) | 421 of 1,898 (22.2%)
2022 | 969 of 4,702 (20.6%) | 149 of 739 (20.2%) | 228 of 581 (39.2%) | 63 of 1,191 (5.3%) | 334 of 1,675 (19.9%)
2023 | 905 of 4,762 (19.0%) | 182 of 854 (21.3%) | 205 of 545 (37.6%) | 48 of 1,227 (3.9%) | 289 of 1,497 (19.3%)
2024 | 957 of 4,755 (20.1%) | 154 of 789 (19.5%) | 248 of 589 (42.1%) | 49 of 1,167 (4.2%) | 329 of 1,542 (21.3%)
2025 | 1,071 of 4,896 (21.9%) | 209 of 817 (25.6%) | 223 of 558 (40.0%) | 64 of 1,174 (5.5%) | 384 of 1,600 (24.0%)
2026 (January through October) | 937 of 4,534 (20.7%) | 138 of 691 (20.0%) | 185 of 543 (34.1%) | 66 of 1,100 (6.0%) | 318 of 1,391 (22.9%)

LIMITS
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. Some sponsors enter a very high number (for example 99 or 100 years) where others leave the field empty; both are counted here as no limit below 80. The disease fields are assigned by the registry's automated indexing. A study with one US site and many sites elsewhere counts as a US trial. Each trial counts once, whatever its size. The registry's NIH class does not capture every trial the NIH funds, and the NIH policy permits a limit that comes with a justification, so the NIH-linked series shows a trend and is no test of compliance. The phase 1 solid tumor pool comes from a condition text search. Start-year groups include trials later withdrawn or terminated. Only two fields, Mental disorders and Cancers, were tracked by start year.

POLICY TEXTS
FDA, Early-Phase IND Protocol Recommendations for Solid Tumors, draft guidance, November 2026, and NIH notice NOT-OD-18-116, effective for applications due on or after January 25, 2019.