Evidence map›Paper›PMID 37069466›Full record

ArticleTherapeutic innovation & regulatory science2023

The Data Monitoring Committee: A Collective or a Collection?

Janet Wittes, Thomas Fleming, David DeMets, Susan Ellenberg, Hertzel Gerstein, Marc Pfeffer, Frank Rockhold, Salim Yusuf, Charles Hennekens

Abstract read
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In one paragraph

Article in Therapeutic innovation & regulatory science, 2023. 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

9 authors.

Janet WittesWittes LLC, Washington, DC, USA. Janet@Wittesllc.com.ORCID 0000-0002-6625-835X
Thomas FlemingUniversity of Washington, Seattle, WA, USA.
David DeMetsUniversity of Wisconsin-Madison, Madison, WI, USA.
Susan EllenbergUniversity of Pennsylvania, Philadelphia, PA, USA.
Hertzel GersteinPopulation Health Research Institute and Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Marc PfefferHarvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
Frank RockholdDuke University Medical Center and The Duke Clinical Research Institute, Durham, NC, USA.
Salim YusufPopulation Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Canada.
Charles HennekensFlorida Atlantic University, Boca Raton, FL, USA.

Funding

National Institute of Health R37-AI29168
6 · The paper itself

Abstract

In this commentary, we urge that a Data Monitoring Committee (DMC) should operate as a collective, that is, as a unitary whole. In so doing, its recommendations should emerge through a consensus development process, not through a vote of the members. The summary notes of its closed session, that is, its minutes, should report the recommendations of the DMC and, if necessary, the justification for those recommendations; it should not attribute opinions to individual members. Importantly, the proceedings of the DMC meetings should not be electronically recorded.

Indexed as

Clinical Trials Data Monitoring CommitteesConsensusData monitoring committeeElectronic recordingInterim analysisMinutesRandomized controlled trialsSafety

Identifiers

PMID37069466

What OpenQuestion holds

Textmetadata
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.