Evidence map›Paper›PMID 37745930›Full record

ArticleJournal of clinical and translational science2023

The evolving role of data & safety monitoring boards for real-world clinical trials.

Bryan J Bunning, Haley Hedlin, Jonathan H Chen, Jody D Ciolino, Johannes Opsahl Ferstad, Emily Fox, Ariadna Garcia, Alan Go, Ramesh Johari, Justin Lee and 9 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

19 authors.

Bryan J BunningQuantitative Sciences Unit, Stanford University, Stanford, CA, USA.ORCID https://orcid.org/0000-0003-3092-0038
Haley HedlinQuantitative Sciences Unit, Stanford University, Stanford, CA, USA.
Jonathan H ChenStanford Center for Biomedical Informatics Research, Stanford University, Stanford, CA, USA.
Jody D CiolinoDepartment of Preventative Medicine - Biostatistics, Northwestern University, Chicago, IL, USA.ORCID https://orcid.org/0000-0002-9060-5657
Johannes Opsahl FerstadDepartment of Management Science and Engineering, Stanford University, Stanford, CA, USA.
Emily FoxDepartment of Statistics, Stanford University, Stanford, CA, USA.
Ariadna GarciaQuantitative Sciences Unit, Stanford University, Stanford, CA, USA.
Alan GoDepartment of Computer Science, Stanford University, Stanford, CA, USA.
Ramesh JohariDepartment of Management Science and Engineering, Stanford University, Stanford, CA, USA.
Justin LeeQuantitative Sciences Unit, Stanford University, Stanford, CA, USA.
David M MaahsDepartment of Pediatrics, Stanford Medicine Children's Hospital, Stanford, CA, USA.
Kenneth W MahaffeyStanford Center for Clinical Research, Stanford University, Stanford, CA, USA.
Krista Opsahl-OngDepartment of Pediatrics, Stanford Medicine Children's Hospital, Stanford, CA, USA.
Marco PerezDepartment of Medicine, Cardiovascular Medicine, Stanford Medicine, Stanford, CA, USA.
Kaylin RochfordDepartment of Management Science and Engineering, Stanford University, Stanford, CA, USA.
David ScheinkerSystems Design and Collaborative Research, Stanford Medicine Children's Hospital, Stanford, CA, USA.
Heidi SprattDepartment of Preventative Medicine & Community Health, University of Texas Medical Branch, Galveston, TX, USA.ORCID https://orcid.org/0000-0002-9420-5028
Mintu P TurakhiaStanford Center for Clinical Research, Stanford University, Stanford, CA, USA.
Manisha DesaiQuantitative Sciences Unit, Stanford University, Stanford, CA, USA.ORCID https://orcid.org/0000-0002-6949-2651

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
NCATS NIH HHS UL1 TR003142
6 · The paper itself

Abstract

Introduction: Clinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor. Methods: Three examples of real-world trials that leverage different types of data sources - wearables, medical devices, and electronic health records are described. Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived. Results: Insight and recommendations are given on four topic areas: A. Charge of the DSMB; B. Composition of the DSMB; C. Pre-launch Activities; and D. Post-launch Activities. We recommend stronger and additional focus on data integrity. Conclusions: Clinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. The data, however, present a level of informatic complexity that relies heavily on a robust data science infrastructure. The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials.

Indexed as

Clinical trialsdata and safety monitoring boarddata integritydata qualitydecentralizeddigitalDSMBpragmaticreal world datareal-world datareal-world evidenceRWD

Identifiers

PMID37745930
PMCPMC10514684

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.