ideasIdea
Follow every trial participant for 30 years through registry linkage
Trials stop following patients after a few years, so late side effects and late relapses are missed. Link trial participants to national records so follow-up continues automatically for decades.
Late effects of cancer treatment (second cancers, cardiac disease, endocrine failure) appear decades later, long after trials close. The Childhood Cancer Survivor Study shows the value of long follow-up but relies on costly active contact. The proposal requires consent for registry linkage in every publicly funded trial and funds automated linkage of trial participants to cancer, death and hospital records for 30 years, with pooled analysis across trials.
Hypothesis
Passive registry follow-up will capture more than 95 percent of deaths and second cancers in trial participants at a small fraction of the cost of active follow-up, and will detect late toxicity signals for at least one widely used regimen within five years.
Rationale
Nordic trial groups already do this; the survival curves for several adjuvant trials were extended by a decade at negligible cost through registry linkage.
What would test it
Link participants from five completed cooperative-group trials to registries; compare completeness and cost with the trials' original active follow-up; report late events.
Maturity
early clinical
Who has to act
research
Cost to try
Small (under $1M)
Years to first evidence
3
Bottlenecks it attacks
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Survivorship and late effects are neglected · Tens of millions of people live after cancer with heart damage, infertility, second cancers and fear, and few services.
- Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.