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Ideas
Aggregated single-patient crossover trials for symptom and supportive treatments

Aggregated single-patient crossover trials for symptom and supportive treatments

For symptoms such as nausea, fatigue or neuropathy, each patient can alternate the drug and a placebo over several periods and learn what works for them. Pooling these single-patient crossover trials with Bayesian models also gives a population answer, in areas where conventional trials are rare.

Overview Key papers1 Connected4

Overview

N-of-1 trials (multiple randomised crossover periods within one patient) with ePRO outcomes are aggregated across patients using Bayesian hierarchical models to estimate both population and individual effects. Suitable for chronic, stable symptoms and reversible treatments (antiemetics, neuropathic pain agents, appetite stimulants, sleep aids) where conventional RCTs are rare because there is little commercial incentive.

Hypothesis

Aggregated N-of-1 designs will answer supportive-care questions with a fifth of the patients required by parallel-group trials and will give each participant a personal answer they act on.

Rationale

Supportive care is under-researched relative to its impact on QoL. N-of-1 designs are statistically efficient for stable conditions and are inherently patient-centred.

Proposed test

Run a platform of N-of-1 trials for three common symptoms in a survivorship clinic with a smartphone ePRO app and compare precision per patient with the literature.

Maturity

speculative

Who acts

research

Cost to try

Small (under $1M)

Years to first evidence

2

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.
Cachexia, toxicity and the limits of the patient · Cancer cachexia, the muscle and fat wasting driven by tumour and host inflammatory signals, affects most patients with advanced pancreatic, gastric and lung cancer, and treatment-limiting toxicities decide what dose a patient can receive. Only Japan has an approved cachexia drug, and supportive care research gets a small share of funding relative to its effect.

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
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
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
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, 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
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, Trial design, endpoints and cost.
Idea
Qualify a physical function endpoint so anti-wasting drugs can be approved
Shares Cachexia, toxicity and the limits of the patient, Exercise & lifestyle oncology, 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
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.

technologies

Exercise & lifestyle oncology

bottlenecks

Cachexia, toxicity and the limits of the patient 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 2026-09-11 · Jude Gomila · TL;DR clarity pass · 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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Exercise & lifestyle oncology

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