Evidence map›Paper›PMID 36575335›Full record

SynthesisApplied health economics and health policy2023

An Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials.

Chris Schilling, Michelle Tew, Samantha Bunzli, Cade Shadbolt, L Stefan Lohmander, Zsolt J Balogh, Francesco Paolucci, Peter F Choong, Michelle M Dowsey, Philip Clarke

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Applied health economics and health policy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 4 countries.

Chris SchillingDepartment of Surgery, The University of Melbourne, Melbourne, Australia.
Michelle TewMelbourne School of Population and Global Health, Centre for Health Policy, University of Melbourne, Melbourne, Australia. michelle.tew@unimelb.edu.au.ORCID http://orcid.org/0000-0003-3009-8056
Samantha BunzliDepartment of Surgery, The University of Melbourne, Melbourne, Australia.
Cade ShadboltDepartment of Surgery, The University of Melbourne, Melbourne, Australia.
L Stefan LohmanderDepartment of Clinical Sciences Lund, Orthopaedics, University of Lund, Lund, Sweden.
Zsolt J BaloghSchool of Medicine and Public Health, Department of Traumatology, John Hunter Hospital, The University of Newcastle, Newcastle, Australia.
Francesco PaolucciCollege of Human and Social Futures, The Newcastle Business School, University of Newcastle, Newcastle, Australia.
Peter F ChoongDepartment of Surgery, The University of Melbourne, Melbourne, Australia.
Michelle M DowseyDepartment of Surgery, The University of Melbourne, Melbourne, Australia.
Philip ClarkeMelbourne School of Population and Global Health, Centre for Health Policy, University of Melbourne, Melbourne, Australia.
The University of Melbourne · AUJohn Hunter Hospital · AULund University · SEUniversity of Newcastle Australia · AU

Funding

National Health and Medical Research Council APP1122526National Health and Medical Research Council APP1154203National Health and Medical Research Council of Australia APP1163613
6 · The paper itself

Abstract

BACKGROUND AND

objectiveWaste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates.

methodsWe parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial.

resultsSuccessful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials.

conclusionsThis model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.

Indexed as

BudgetsModels, EconomicCost-Benefit AnalysisHumans

Identifiers

PMID36575335
PMCPMC9931787
OpenAlexW4313236387

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.