{"entity":{"id":"idea-tr1-seamless-2-3-with-prespecified-go","kind":"idea","name":"Seamless phase 2/3 with pre-registered go rules as the default for new agents","aka":[],"tldr":"Instead of stopping after the mid-sized trial, waiting a year, then starting the big one, run them as one study with a clear pre-agreed rule for continuing. This saves a year or more per drug.","summary":"Adaptive seamless designs where the phase 2 portion (dose or population selection) rolls into the phase 3 portion without a pause, with a pre-registered decision rule, an independent committee applying it, and appropriate statistical control of type I error. The idea is to make this the expected design for agents with a plausible registrational path, with regulators offering fast-track review of the adaptation plan.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trial design, endpoints and cost): Davis et al., Availability of evidence of benefits on survival and quality of life of cancer drugs approved by EMA 2009-13 (BMJ 2017)","url":"https://doi.org/10.1136/bmj.j4530"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["pfs","os"],"trials":[],"people":[],"bottlenecks":["b-trial-design"],"keyPapers":["paper-davis-bmj"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Programmes using seamless 2/3 designs will reach primary phase 3 read-out at least 12 months sooner than matched programmes with separate phases, without a higher rate of failed phase 3s.","rationale":"Operational pauses between phases account for a sizeable share of development time. Seamless designs have supported approvals in several cancers; the remaining barrier is habit and the need for early commitment to the confirmatory endpoint.","test":"Compare development timelines (first-in-human to pivotal read-out) for seamless versus sequential programmes in the same drug class, using registry start and completion dates.","maturity":"being-tested-at-scale","actor":"industry","cost":"large","horizonYears":3},"route":"/ideas/idea-tr1-seamless-2-3-with-prespecified-go/","neighbours":{"term":[{"id":"os","kind":"term","name":"Overall survival (OS)","route":"/terms/os/"},{"id":"pfs","kind":"term","name":"Progression-free survival (PFS)","route":"/terms/pfs/"}],"bottleneck":[{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}],"paper":[{"id":"paper-davis-bmj","kind":"paper","name":"Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13","route":"/key-papers/paper-davis-bmj/"}]}}