Evidence map›Paper›PMID 36047276›Full record

Trial reportEthics & human research2022

Informed Consent for Placebo-Controlled Trials: Do Ethics and Science Conflict?

Hope A Feldman, James A Feldman, Charles C Miller, Garrett Walsh, Jon E Tyson

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Ethics & human research, 2022. 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
–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. Placebo-resistant gut bacteria:Frontiers in cellular and infection microbiology · 2024
    Trial
  2. Review
  3. GutWomen's health reports (New Rochelle, N.Y.) · 2024
    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

5 authors.

Hope A FeldmanResearch fellow in the Department of Thoracic and Cardiovascular Surgery at the University of Texas MD Anderson Cancer Center.
James A FeldmanSenior investigator in the Department of Emergency Medicine at the Boston Medical Center at the Boston University School of Medicine.
Charles C MillerAssociate vice president of clinical research at the University of Texas Health Science Center at Houston in the McGovern Medical School.
Garrett WalshProfessor of surgery in the Department of Thoracic and Cardiovascular Surgery at the University of Texas MD Anderson Cancer Center.
Jon E TysonVice dean for clinical research at the University of Texas Health Science Center at Houston in the McGovern Medical School.

Funding

Project-005UL1TR001430 · NCATS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI BAIR-MERRITT, MEGAN H, CENTER, DAVID M. · 2015 to 2024
$52.3M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Boston University Clinical and Translational Science Institute 1UL1TR001430Boston University Clinical and Translational Science Institute JAFClinical and Translational Science 5UL1TR003167Clinical and Translational Science CCMClinical and Translational Science JETNCATS NIH HHS UL1 TR001430NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

The use of a placebo has been considered the best method for controlling bias in a prospective randomized clinical trial and provides the most rigorous test of treatment efficacy for evaluating a medical therapy. Placebos commonly produce clinically important effects particularly in studies where the primary outcomes are subjective. Yet the potential beneficial or harmful effects of placebos are often not addressed in designing a clinical trial, calculating the sample size, seeking consent, or interpreting clinical trial results. In this manuscript, we use an actual study to indicate three approaches that might be considered in seeking informed consent for placebo-controlled trials, and we explore the fundamental ethical and scientific complexities involved with each.

Indexed as

Informed ConsentResearch DesignHumansProspective StudiesTreatment Outcomehuman research ethicshuman subjects researchinformed consentnocebo effectplacebo-controlled trialsrandomized controlled trials

Identifiers

PMID36047276
PMCPMC9841466

What OpenQuestion holds

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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.