Evidence map›Paper›PMID 34939559›Full record

ReviewCurrent reviews in clinical and experimental pharmacology2023

Review of Clinical Equipoise: Examples from Oncology Trials.

Majd A AlHamaly, Karem H Alzoubi, Omar F Khabour, Ruba A Jaber, Wael K Aldelaimy

Abstract readReview
In one paragraph

Review in Current reviews in clinical and experimental pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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.

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, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
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

5 authors.

Majd A AlHamalyCollege of Medicine, University of Kentucky, Lexington, KY, USA.
Karem H AlzoubiDepartment of Clinical Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.
Omar F KhabourDepartment of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid, Jordan.
Ruba A JaberDepartment of Clinical Research and Development, Hikma Pharmaceuticals, Amman, Jordan.
Wael K AldelaimySchool of Public Health, University of California San Diego, La Jolla, CA, USA.

Funding

The Research Ethics Education Program in JordanR25TW010026 · FIC · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI AL-DELAIMY, WAEL K · 2015 to 2025
$2.5M
FIC NIH HHS R25 TW010026
6 · The paper itself

Abstract

backgroundThe current standards that govern clinical research have been shaped over the years through many historical, social, and political events. The third principle of the Belmont Report, Justice, guides the scientific community toward the equal distribution of benefits and risks in research involving human subjects. Clinical equipoise is the status of genuine uncertainty by the investigator about the superiority of one treatment arm over the other. The term clinical equipoise was proposed to provide an ethical ground to conduct randomized controlled clinical trials.

objectiveThe objective of this review is to provide the reader with an overview of the emergence of the term equipoise and its utilization in randomized controlled trials.

methodsIn the current review article, the major oncology clinical trials and relevant patents were reviewed for the application/utilization of clinical equipoise.

resultsThe concept of clinical equipoise has been challenged, and different alternatives were proposed. Yet, these alternatives received numerous critiques and failed to fully replace equipoise. In addition, several patents related to anticancer agents tested in the described studies were examined. No specific reference was made as part of the patent to the status of clinical equipoise. Alternatively, a description of the study arms was provided.

conclusionThere is a need for revisiting the concept of equipoise and its suggested alternatives for its ethical essence while addressing related challenges.

Indexed as

Drug Screening Assays, AntitumorNeoplasmsResearch DesignTherapeutic EquipoiseHumansMedical OncologyResearch SubjectsUncertaintyequipoiseEthical standardshuman researchjusticepatentsrandomized controlled trials

Identifiers

PMID34939559
PMCPMC9992762

What OpenQuestion holds

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Registered trials

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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.