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Ideas
Bayesian shrinkage for subgroup claims to stop false 'works in this group' stories

Bayesian shrinkage for subgroup claims to stop false 'works in this group' stories

Trials look at dozens of patient subgroups and some will look good by chance. A statistical method that pulls extreme subgroup results toward the overall result would make these claims more honest.

Overview Key papers1 Connected4

Overview

Forest plots of subgroup effects are replaced or accompanied by hierarchical Bayesian shrinkage estimates, in which each subgroup effect is partially pooled toward the overall effect according to its precision. Regulators require shrunken estimates for any subgroup claim in a label and journals require them in publications.

Hypothesis

Shrinkage-based subgroup reporting will reduce the number of subgroup-driven label restrictions or expansions that are later reversed, and will improve replication of subgroup effects in subsequent trials.

Rationale

Naive subgroup estimates are noisy and biased toward extremes when selected; shrinkage is the standard remedy in other fields and would have avoided several well-known oncology subgroup reversals.

Proposed test

Re-analyse subgroup claims from past label decisions with shrinkage and check which would have survived; compare with later replication data.

Maturity

speculative

Who acts

regulator

Cost to try

Small (under $1M)

Years to first evidence

1

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.
Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.

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
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, Hazard ratio (HR), Trial design, endpoints and cost.
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, Failures are hidden, 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, Failures are hidden, Trial design, endpoints and cost.
Idea
Seamless phase 2/3 with pre-registered go rules as the default for new agents
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
Competing sponsors share one control arm in the same indication
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
Borrow from past control arms to shrink the control group in phase 3
Shares Hazard ratio (HR), Trial design, endpoints and cost.
Idea
SMART designs to test treatment strategies, not just single drugs
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.

terms

Hazard ratio (HR)

bottlenecks

Failures are hidden 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)

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Terms

Hazard ratio (HR)

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.

Machine-readable versions of Bayesian shrinkage for subgroup claims to stop false 'works in this group' stories

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