Evidence map›Paper›PMID 33865474›Full record

ReviewThe Lancet. Global health2021

Randomised trials at the level of the individual.

Jay J H Park, Nathan Ford, Denis Xavier, Per Ashorn, Rebecca F Grais, Zulfiqar A Bhutta, Herman Goossens, Kristian Thorlund, Maria Eugenia Socias, Edward J Mills

Registry-linked trialAbstract readReview
PubMed Publisher
In one paragraph

Review in The Lancet. Global health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04727424 (A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT04727424 phase3unknown statusnot on this map

A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19

TypeinterventionalSponsorCardresearchRan2021 to 2024Enrolled7,819ConditionsCovid19, SARS-Associated CoronavirusArmsSpirulin Platensis, Budesonide Powder, Fluoxetine 20 MG, Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.BMJ surgery, interventions, & health technologies · 2024
    Article
  7. Article
  8. Article
  9. The economic challenges of new drug development.Journal of controlled release : official journal of the Controlled Release Society · 2022
    Article
  10. Review
  11. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Jay J H ParkDepartment of Experimental Medicine, University of British Columbia, Vancouver, BC, Canada.
Nathan FordCentre for Infectious Disease Epidemiology and Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
Denis XavierDepartment of Pharmacology and Divison of Clinical Research, St John's Medical College, Bangalore, India.
Per AshornFaculty of Medicine and Health Technology, Tampere University, Tampere, Finland.
Rebecca F GraisEpicentre, Paris, France.
Zulfiqar A BhuttaCentre for Global Child Health, Hospital for Sick Children, Toronto, ON, Canada; Institute of Global Health and Development, and Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.
Herman GoossensLaboratory of Medical Microbiology, University of Antwerp, Antwerp, Belgium.
Kristian ThorlundDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
Maria Eugenia SociasFundación Huésped, Buenos Aires, Argentina; British Columbia Centre for Substance Use, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Edward J MillsDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; School of Public Health, University of Rwanda, Kigali, Rwanda; Cytel, Vancouver, BC, Canada. Electronic address: millsej@mcmaster.ca.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In global health research, short-term, small-scale clinical trials with fixed, two-arm trial designs that generally do not allow for major changes throughout the trial are the most common study design. Building on the introductory paper of this Series, this paper discusses data-driven approaches to clinical trial research across several adaptive trial designs, as well as the master protocol framework that can help to harmonise clinical trial research efforts in global health research. We provide a general framework for more efficient trial research, and we discuss the importance of considering different study designs in the planning stage with statistical simulations. We conclude this second Series paper by discussing the methodological and operational complexity of adaptive trial designs and master protocols and the current funding challenges that could limit uptake of these approaches in global health research.

Indexed as

Global HealthResearch DesignAdaptive Clinical Trials as TopicHumansRandomized Controlled Trials as Topic

Identifiers

PMID33865474

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

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 Socratic graph.