Evidence map›Paper›PMID 24321985›Full record

ArticleJournal of acquired immune deficiency syndromes (1999)2014

Ensuring participant safety and trial integrity with clinical trials oversight.

Catherine Godfrey, Manizhe Payton, Sybil Tasker, Scott Proestel, Jeffrey T Schouten

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of acquired immune deficiency syndromes (1999), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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.

Catherine Godfrey*HIV Research Branch and the Office of Clinical Site Oversight at the Division of AIDS, National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID), Bethesda, MD; †PRA International, Raleigh, NC; and ‡Office of HIV/AIDS Network Coordination, Fred Hutchinson Cancer Research Center, Seattle, WA.
Manizhe Payton
Sybil Tasker
Scott Proestel
Jeffrey T Schouten

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
Intramural NIH HHS Z99 AI999999NIAID NIH HHS U01 AI068614NIAID NIH HHS UM01 AI068614NIAID NIH HHS UM1 AI068614NIAID NIH HHS Y99 AI999999
6 · The paper itself

Abstract

Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected. The trial sponsor, a local Institutional Review Board, and independent monitoring committees all contribute with complementary but overlapping responsibilities. Consistency among these groups is essential for the smooth conduct of a clinical trial but may be challenging in resource-limited settings (RLS). Capacity building and training for RLS may improve clinical trials oversight and ultimately medical management. In this article, we review the components necessary for optimal clinical trial oversight and the issues that arise in the RLS, with some suggested strategies for improvement.

Indexed as

Biomedical ResearchResearch SubjectsClinical Trials as TopicClinical Trials Data Monitoring CommitteesEthics Committees, ResearchHealth ResourcesHIV InfectionsHumansPatient SafetyPharmacovigilanceRisk Assessment

Identifiers

PMID24321985
PMCPMC3916962

What OpenQuestion holds

Textmetadata
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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.