{"entity":{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","aka":[],"tldr":"We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.","summary":"Regulatory approval, increasingly on surrogate endpoints and single-arm trials, is meant to be followed by confirmation in practice, but the systems to do that are weak. Of cancer drugs given accelerated approval in the US over a quarter-century, only a minority later showed an overall survival benefit in a confirmatory trial, and many confirmatory studies used the same surrogate as the original approval. Post-marketing commitments are often delayed or unmet. Population cancer registries record incidence, stage and death but rarely treatment or recurrence, and treatment datasets such as the NHS SACT are the exception rather than the rule. Real-world effectiveness in older, sicker, more diverse patients is frequently lower than trial efficacy, and without linked outcome data neither payers nor clinicians can tell which drugs deliver. Regulatory frameworks for real-world evidence, national treatment registries and clinico-genomic databases are the building blocks; completeness and outcome capture remain the gap.","asOf":"2026-09-08","links":[{"label":"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"},{"label":"FDA Real-World Evidence","url":"https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence"},{"label":"FDA Oncology Center of Excellence, Project Confirm","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-confirm"},{"label":"NHS Systemic Anti-Cancer Therapy dataset","url":"https://digital.nhs.uk/ndrs/data/data-sets/sact"}],"tags":[],"related":["fda-approvals","seer","globocan","esmo-guidelines","clinicaltrials-gov","idea-data-rwe-rct-calibration-library","idea-data-accelerated-approval-registry-condition","idea-data-rwpfs-validation-programme","idea-data-registry-based-rcts","idea-data-off-label-outcomes-registry","idea-data-real-world-dose-intensity","idea-data-excluded-populations-rwe-mandate","idea-data-linked-pharmacovigilance-interactions","idea-data-access-programme-outcomes","idea-data-registry-genomics-linkage-programme","idea-data-observational-study-registration","idea-data-gcp-for-real-world-data","idea-data-registry-follow-up-of-trial-participants","idea-data-wearable-endpoints-validation","idea-data-external-control-arm-standard","idea-data-paediatric-rwe-consortium","idea-data-sequencing-analysis-per-approval","idea-data-outcome-based-price-reassessment","idea-moon-federated-rwe-network"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["foundation-medicine","tempus","guardant-health"],"institutions":["asco","esmo","nci"],"pathways":[],"terms":["real-world-evidence","accelerated-approval","os","pfs"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"stage":"data-knowledge","severity":"major","metrics":[{"label":"Cancer drug indications granted FDA accelerated approval 1992-2017 that later demonstrated an overall survival benefit in a confirmatory trial","value":"19 of 93 (20%)","source":"Gyawali, Hey & Kesselheim, JAMA Internal Medicine 2019","url":"https://doi.org/10.1001/jamainternmed.2019.0462"},{"label":"Cancer drug indications approved by the EMA 2009-2013 still lacking evidence of survival or quality-of-life benefit after a median 5.4 years","value":"About half","source":"Davis et al., BMJ 2017","url":"https://doi.org/10.1136/bmj.j4530"}],"causes":["Population registries were designed for incidence and mortality surveillance, not treatment and outcomes.","Sponsors have little incentive to complete confirmatory trials quickly once a drug is on the market.","Real-world data lack structured capture of progression, response and toxicity.","Confounding by indication makes non-randomised comparisons unreliable without careful design.","Regulators have historically been reluctant to withdraw approvals on the basis of missing or negative confirmatory data."],"currentEfforts":["The FDA Real-World Evidence Framework (2018, under the 21st Century Cures Act) and Oncology Center of Excellence Project Confirm track and publish the status of accelerated approvals and confirmatory trials.","The Flatiron Health-Foundation Medicine clinico-genomic database links sequencing to longitudinal outcomes for tens of thousands of patients and has supported FDA decisions.","The EMA's DARWIN EU network runs real-world studies across European data sources for regulatory questions.","The NHS Systemic Anti-Cancer Therapy (SACT) dataset records every systemic therapy episode in England with outcomes, and the Cancer Drugs Fund uses it for managed-access re-evaluation.","SEER-Medicare linkage and the NCI SEER programme provide population-level treatment and survival for US patients over 65.","ASCO's TAPUR and registry trials generate prospective evidence for off-label targeted therapy."],"successLooksLike":"Every approved cancer drug has post-approval effectiveness and safety data published within three years from national treatment registries, accelerated approvals are confirmed or withdrawn on schedule, and real-world survival is tracked and reported alongside trial results in guidelines."},"route":"/bottlenecks/b-real-world-evidence/","neighbours":{"collection":[{"id":"bccss","kind":"collection","name":"British Childhood Cancer Survivor Study (BCCSS)","route":"/collections/bccss/"},{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"esmo-guidelines","kind":"collection","name":"ESMO Clinical Practice Guidelines & MCBS","route":"/collections/esmo-guidelines/"},{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","route":"/collections/fda-approvals/"},{"id":"globocan","kind":"collection","name":"GLOBOCAN / Global Cancer 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