{"entity":{"id":"idea-data-sequencing-analysis-per-approval","kind":"idea","name":"A real-world sequencing analysis within a year of every new approval","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Weak real-world evidence and registries): Gyawali, Hey & Kesselheim, Assessment of the clinical benefit of cancer drugs receiving accelerated approval (JAMA Intern Med 2019)","url":"https://doi.org/10.1001/jamainternmed.2019.0462"}],"tags":[],"related":["idea-data-federated-analytics-network"],"cancers":[],"sections":["ai-computation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["real-world-evidence","adc-sequencing"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence","b-knowledge-diffusion","b-combination-space"],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"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.","test":"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","actor":"research","cost":"medium","horizonYears":2},"route":"/ideas/idea-data-sequencing-analysis-per-approval/","neighbours":{"idea":[{"id":"idea-data-federated-analytics-network","kind":"idea","name":"Send the code to the data: a federated analytics network of cancer centres","route":"/ideas/idea-data-federated-analytics-network/"}],"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"term":[{"id":"adc-sequencing","kind":"term","name":"ADC sequencing","route":"/terms/adc-sequencing/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-knowledge-diffusion","kind":"bottleneck","name":"Knowledge reaches practice too slowly","route":"/bottlenecks/b-knowledge-diffusion/"},{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}],"paper":[{"id":"paper-gyawali-jama-intern-med","kind":"paper","name":"Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval","route":"/key-papers/paper-gyawali-jama-intern-med/"}]}}