Evidence map›Paper›PMID 41103840›Full record

ArticleCureus2025

The Essential Role of Medical Monitors in Clinical Trials.

Gerald L Klein, Elizabeth Barabash, Roger E Morgan, Gail Brown, Mark Tulchinskiy, Freddy Byrth, Emilia Jones Amaowei, Pavle Vukojevic, Shabnam Vaezzadeh, Katie-Louise Dawson and 5 more

Abstract readEditorial
PubMed Full text at PMC Publisher
In one paragraph

Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Gerald L KleinMedical Affairs, MedSurgPI, Pittsboro, USA.
Elizabeth BarabashStrategy and Development, People Value Research Ltd., Ipswich, GBR.
Roger E MorganClinical Development, MedSurgPI, Raleigh, USA.
Gail BrownInternal Medicine and Medical Oncology, MedSurgPI, San Jose, USA.
Mark TulchinskiyMedical Affairs, MedSurgPI, Morrisville, USA.
Freddy ByrthClinical Operations, MedSurgPI, Chapel Hill, USA.
Emilia Jones AmaoweiMedical Affairs, MedSurgPI, Pearland, USA.
Pavle VukojevicRheumatology, Optimapharm, Belgrade, SRB.
Shabnam VaezzadehMedical Affairs, Exquisite Biomedical Consulting, Vancouver, CAN.
Katie-Louise DawsonPharmaceutical Medicine, MedSurgPI, Chalfont, USA.
Gabriel CohnObstetrics and Gynecology, MedSurgPI, Longmeadow, USA.
Stephen HaworthInternal Medicine, MedSurgPI, London, GBR.
Anne Blackwood-ChirchirOncology, MedSurgPI, El Cerrito, USA.
Johannes WolffOncology, MedSurgPI, Puyallup, USA.
Angela OvertonPharmacovigilance, Prevail InfoWorks Inc., Philadelphia, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Medical monitors (MMs) play a critical and often underrecognized role in ensuring patient safety, regulatory compliance, and scientific integrity during clinical trials. Particularly in early-stage pharma, biotechnology, and medical device development, the MM serves as an independent safeguard against bias and unanticipated risks. This editorial outlines the rationale, responsibilities, and operational value of the MM role, emphasizing its function in document review, real-time safety oversight, and regulatory alignment. Through illustrative case studies and current best practices, we argue that the independence and objectivity of the MM is a strategic business necessity, not merely a regulatory checkbox.

Indexed as

clinical trials in all phases (i-iv)drug and deviceinvestigator brochuremedical monitorprotocolssafety patientus fda

Identifiers

PMID41103840
PMCPMC12527326

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.