ideasIdea
A real-world sequencing analysis within a year of every new approval
Trials tell us a drug works but not where it fits among the others. Commit to answering 'which order' from hospital data within a year of each approval.
The question clinicians face after approval is sequence: first or second line, before or after the previous standard. Trials rarely address it. The proposal is a funded programme that, for every new oncology approval, runs a pre-registered target trial emulation of sequencing strategies in federated data within 12 months, published in a standard format and fed into guidelines as explicitly graded real-world evidence.
Hypothesis
Systematic sequencing analyses will change guideline sequencing recommendations for at least a quarter of new approvals within two years of approval, and will identify sequences associated with worse survival that were being used in practice.
Rationale
Sequencing analyses of ADCs, CDK4/6 inhibitors and immunotherapy have emerged from academic real-world studies years late; making them systematic and timely is a funding and infrastructure decision.
What would test it
Run the programme for one year of approvals in one federated network; count analyses delivered on time and guideline citations within 24 months.
Maturity
speculative
Who has to act
research
Cost to try
Medium ($1M to $50M)
Years to first evidence
2
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.
- Knowledge reaches practice too slowly · Knowledge diffusion is slow: it takes years for a proven result to change what most patients receive, and no one can keep up with the literature.
- Too many combinations to test · There are thousands of possible drug pairs and sequences. Trials can test a few dozen a year.