{"entity":{"id":"idea-bio1-approval-linked-progression-sampling","kind":"idea","name":"Make post-progression sampling a condition of accelerated approval","aka":[],"tldr":"Drugs approved on early evidence come with follow-up obligations. One of them should be finding out how tumours escape the new drug.","summary":"Accelerated approvals already carry confirmatory trial requirements. Adding a resistance-characterisation commitment (a specified number of paired progression samples with mechanism reporting into a public database within a defined period) would ensure the field learns how each new agent fails while the drug is still early in its lifecycle, rather than a decade later.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Acquired resistance to every therapy): Soria et al., Osimertinib in untreated EGFR-mutated NSCLC (FLAURA, NEJM 2018)","url":"https://doi.org/10.1056/NEJMoa1713137"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["accelerated-approval","resistance"],"trials":[],"people":[],"bottlenecks":["b-resistance","b-regulatory-fragmentation","b-negative-results"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Approval-linked sampling commitments produce mechanism data for new agents years earlier than the status quo and demonstrably shape the design of successor agents and combinations.","rationale":"Post-marketing requirements are an established regulatory instrument and are already used for dose optimisation under Project Optimus; the incremental cost to a sponsor is small relative to the value of the information.","test":"Apply the requirement to a small number of new approvals as a pilot and compare time-to-first-published-mechanism with matched historical approvals.","maturity":"speculative","actor":"regulator","cost":"small","horizonYears":5},"route":"/ideas/idea-bio1-approval-linked-progression-sampling/","neighbours":{"term":[{"id":"accelerated-approval","kind":"term","name":"Accelerated approval","route":"/terms/accelerated-approval/"},{"id":"resistance","kind":"term","name":"Drug resistance (primary and acquired)","route":"/terms/resistance/"}],"bottleneck":[{"id":"b-resistance","kind":"bottleneck","name":"Acquired resistance to every therapy","route":"/bottlenecks/b-resistance/"},{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"}]}}