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Ideas
Seamless phase 2/3 with pre-registered go rules as the default for new agents

Seamless phase 2/3 with pre-registered go rules as the default for new agents

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.

Overview Key papers1 Connected4

Overview

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.

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.

Proposed 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

Who acts

industry

Cost to try

Large (over $50M)

Years to first evidence

3

Bottlenecks it attacks

Trial design, endpoints and cost · A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on.

Key papers

observationalBMJ 2017390 citations

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

Two bottleneck pages and 15 idea pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.

Connected

Similar pages

Idea
Require a randomised phase 2 before any phase 3
Shares 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, Progression-free survival (PFS), Trial design, endpoints and cost.
Idea
Pre-specified crossover-adjusted survival in every trial that allows crossover
Shares 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, Overall survival (OS), Trial design, endpoints and cost.
Idea
Report time toxicity, the days spent in healthcare, as a standard outcome for older patients
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.
Idea
Time to treatment failure and quality of life as co-primary endpoints in non-curative trials
Shares Progression-free survival (PFS), Overall survival (OS), Trial design, endpoints and cost.
Idea
Bayesian shrinkage for subgroup claims to stop false 'works in this group' stories
Shares 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, Trial design, endpoints and cost.
Idea
Aggregated single-patient crossover trials for symptom and supportive treatments
Shares 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, Trial design, endpoints and cost.
Idea
Stop failing trials earlier with pre-registered aggressive futility rules
Shares 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, Trial design, endpoints and cost.
Idea
Report time toxicity, the days a treatment consumes, in every trial and decision aid
Shares Progression-free survival (PFS), Overall survival (OS).

terms

Overall survival (OS)Progression-free survival (PFS)

bottlenecks

Trial design, endpoints and cost

key papers

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

ProvenanceLast edited 2026-09-10 · Jude Gomila · Graph health · diff · file

Sources & links

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)

Data

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Terms

Progression-free survival (PFS)
Overall survival (OS)

Not yet reviewedNeeds expert (scientific) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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