{"entity":{"id":"idea-tr1-age-floor-twelve-for-adult-trials","kind":"idea","name":"Let adolescents from age 12 into adult trials when the cancer biology is the same","aka":[],"tldr":"Teenagers with cancers that are really adult cancers, like melanoma or sarcoma, are barred from adult trials by an age line at 18. Letting them in from age 12, where biology and dosing allow, would give them access years earlier.","summary":"Adult oncology trials in histologies that occur in adolescents (melanoma, sarcomas, Hodgkin lymphoma, germ cell tumours, colorectal in Lynch syndrome) set the minimum age at 12 with weight-based dosing where required and paediatric assent, as FDA guidance permits. Sponsors would need to justify an age floor above 12 in these histologies.","asOf":"2026-09-08","links":[{"label":"FDA: Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-minimum-age-considerations-inclusion-pediatric-patients"}],"tags":[],"related":[],"cancers":["melanoma","sarcoma","hodgkin-lymphoma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity","b-rare-cancers"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Lowering the age floor will enrol adolescents into adult trials at a rate proportional to incidence and shorten the delay between adult and paediatric label extensions from years to months for those histologies.","rationale":"Adolescents fall between paediatric and adult trial systems; the FDA has stated that age 12 is appropriate when biology and PK support it. Paediatric label delays of several years are common.","test":"Compare adolescent enrolment and time to paediatric labelling for agents in trials adopting a 12-year floor versus historical 18-year floors in the same histologies.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-age-floor-twelve-for-adult-trials/","neighbours":{"cancer":[{"id":"hodgkin-lymphoma","kind":"cancer","name":"Hodgkin lymphoma","route":"/cancers/hodgkin-lymphoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}]}}