Evidence map›Paper›PMID 28135804›Full record

ArticleClinical trials (London, England)2017

The interaction between equipoise and logistics in clinical trials: A case study.

Meredith G Warshaw, Vincent J Carey, Elizabeth J McFarland, Liza Dawson, Elaine Abrams, Ann Melvin, Lee Fairlie, Hans Spiegel, Jonathan Jay, Allison L Agwu and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical trials (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03075332 (Detraining in the Components of Physical Aptitude in People Living With HIV/ AIDS), which is not on this 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.

NCT03075332 nacompletednot on this map

Detraining in the Components of Physical Aptitude in People Living With HIV/ AIDS

TypeinterventionalSponsorUniversidade Federal do Rio Grande do NorteRan2016 to 2016Enrolled2ConditionsLipodystrophy Syndrome, HIV, SarcopeniaArmscombined training
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  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

11 authors.

Meredith G Warshaw1 Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Vincent J Carey1 Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Elizabeth J McFarland3 Department of Pediatrics, School of Medicine, University of Colorado, Aurora, CO, USA.
Liza Dawson4 Basic Sciences Program, Division of AIDS, NIAID/NIH/DHHS, Bethesda, MD, USA.
Elaine Abrams5 ICAP, Mailman School of Public Health and College of Physicians and Surgeons, Columbia University, New York, NY, USA.
Ann Melvin6 Division of Pediatric Infectious Disease, Department of Pediatrics, Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.
Lee Fairlie7 Wits Reproductive Health and HIV Institute (WRHI), University of the Witwatersrand, Johannesburg, Johannesburg, South Africa.
Hans Spiegel8 Kelly Government Solutions, Contractor to DAIDS/NIAID/NIH, Rockville, MD, USA.
Jonathan Jay9 Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Allison L Agwu10 Division of Pediatric Infectious Diseases, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
IMPAACT P1094 Team

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

introductionEquipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications.

backgroundClinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY: A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. DISCUSSION: When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.

Indexed as

Clinical Trials as TopicPatient SelectionResearch DesignTherapeutic EquipoiseBiomedical ResearchGlobal HealthHealthcare DisparitiesHIV InfectionsHumansMulticenter Studies as TopicTreatment Adherence and ComplianceUncertaintyenrollmentEquipoiseHIV/AIDSinternational clinical trialslogistics

Identifiers

PMID28135804
PMCPMC5446272

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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 OpenQuestion graph.