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Access to Anticancer Drug Trials for Adolescents With Cancer in the United States
Benjamin Grobman1, David S Shulman1,2, Vinayak Venkataraman1,3
1Harvard Medical School, Boston, Massachusetts, USA.
Background:
Adolescents with cancer are generally underrepresented in clinical trials. The extent to which cancer drug clinical trials have become more age inclusive over time is not clear.
Methods:
We utilized ClinicalTrials.gov to identify cancer drug trials from 2005 to 2025 in the United States. We categorized trials according to age of eligibility as those for adults only versus those that allowed adults as well as patients <18 years of age. For trials with results reported, we also evaluated whether minor participants enrolled in these trials.
Results:
We identified 23,756 trials, of which only 14.3% allowed both adults and minors to participate. This proportion did not show a consistent change over the study period, including in a sensitivity analysis focused on trials with histologies particularly relevant to adolescents (germ cell tumors, Hodgkin lymphoma, and sarcomas). The proportion of industry-funded trials was 45% for adult-only trials versus 24% for trials that also allowed minor participants (p < 0.01). Across most years, more than 25% of trials that allowed minors to participate actually enrolled at least one minor participant. Among trials relevant to germ cell tumors, Hodgkin lymphoma, and sarcoma, more than 50% of trials enrolled minors.
Conclusions:
A small minority of oncology drug trials in the United States extends the age of eligibility below 18 years of age, and this proportion does not appear to be increasing over time. This extended to histologies, including sarcoma and lymphoma, which may be particularly relevant to adolescent patients. Even when the age of eligibility extends below 18 years of age, most trials did not enroll adolescents, including a significant proportion of those focused on histologies most relevant to adolescent patients.
Insights
Few cancer drug trials include adolescents, and this trend isn't improving. Even when eligible, minors are often not enrolled in trials for pediatric cancers.
Area of Science:
- Oncology
- Clinical Trials
- Adolescent Health
Background:
- Adolescents with cancer are underrepresented in clinical trials.
- The trend towards age inclusivity in cancer drug trials is unclear.
Purpose of the Study:
- To assess the trend of age inclusivity in U.S. cancer drug clinical trials from 2005 to 2025.
- To determine the proportion of trials allowing patients under 18 and if minors were enrolled.
Main Methods:
- Utilized ClinicalTrials.gov to identify cancer drug trials in the U.S. (2005-2025).
- Categorized trials by age eligibility (adults only vs. adults and <18 years).
- Evaluated enrollment of minor participants in trials with reported results.
Main Results:
- Only 14.3% of 23,756 identified trials allowed patients under 18.
- This proportion showed no consistent change over time, even for adolescent-relevant histologies.
- Industry-funded trials were less likely to include minors (24%) compared to adult-only trials (45%).
- Over 25% of trials allowing minors enrolled at least one, with over 50% enrolling minors in trials for germ cell tumors, Hodgkin lymphoma, and sarcomas.
Conclusions:
- A small minority of U.S. oncology trials include patients under 18, with no apparent increase over time.
- This lack of age inclusivity extends to histologies relevant to adolescents.
- Many trials allowing minors do not enroll them, even those focused on adolescent-relevant cancers.
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