ideasIdea
Let adolescents from age 12 into adult trials when the cancer biology is the same
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.
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.
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.
What would test it
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
Who has to act
regulator
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
- Rare and paediatric cancers without markets · Taken together rare cancers are a fifth of all cancers, but each one alone is too small for a company to invest in.