Evidence map›Paper›PMID 26374676›Full record

ArticleClinical trials (London, England)2015

Exploring the ethical and regulatory issues in pragmatic clinical trials.

Robert M Califf, Jeremy Sugarman

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical trials (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 103 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 2 pooled it
16.5field-weighted citation impact, top 1% of its field
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

103 citing papers in PubMed, 2 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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43 more citing papers are in PubMed but not listed here.

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

2 authors at 2 institutions in 1 country.

Robert M CaliffDivision of Cardiology, Department of Medicine, School of Medicine, Duke University, Durham, NC, USA Duke Translational Medicine Institute, Duke University, Durham, NC, USA Current affiliation: US Food and Drug Administration, Silver Spring, MD, USA. This paper was submitted prior to Dr. Califf's appointment to the US Food and Drug Administration Robert.Califf@fda.hhs.gov.
Jeremy SugarmanBerman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Johns Hopkins Medicine · USUnited States Food and Drug Administration · US

Funding

Health Care Systems Research Collaboratory SupplementU54AT007748 · NCCIH · DUKE UNIVERSITY · PI CURTIS, LESLEY H, HERNANDEZ, ADRIAN · 2012 to 2017
$15.1M
NCCIH NIH HHS U54 AT007748
6 · The paper itself

Abstract

The need for high-quality evidence to support decision making about health and health care by patients, physicians, care providers, and policy-makers is well documented. However, serious shortcomings in evidence persist. Pragmatic clinical trials that use novel techniques including emerging information and communication technologies to explore important research questions rapidly and at a fraction of the cost incurred by more "traditional" research methods promise to help close this gap. Nevertheless, while pragmatic clinical trials can bridge clinical practice and research, they may also raise difficult ethical and regulatory challenges. In this article, the authors briefly survey the current state of evidence that is available to inform clinical care and other health-related decisions and discuss the potential for pragmatic clinical trials to improve this state of affairs. They then propose a new working definition for pragmatic research that centers upon fitness for informing decisions about health and health care. Finally, they introduce a project, jointly undertaken by the National Institutes of Health Health Care Systems Research Collaboratory and the National Patient-Centered Clinical Research Network (PCORnet), which addresses 11 key aspects of current systems for regulatory and ethical oversight of clinical research that pose challenges to conducting pragmatic clinical trials. In the series of articles commissioned on this topic published in this issue of Clinical Trials, each of these aspects is addressed in a dedicated article, with a special focus on the interplay between ethical and regulatory considerations and pragmatic clinical research aimed at informing "real-world" choices about health and health care.

Indexed as

Biomedical ResearchClinical Trials as TopicDecision MakingHumansNational Institutes of Health (U.S.)Research DesignSurveys and QuestionnairesUnited StatesClinical trialscluster-randomized trialethicsevidence-based medicinelearning health-care systempatient-centered outcomes researchpragmatic clinical trial

Identifiers

PMID26374676
PMCPMC4891194
OpenAlexW2115742677

What OpenQuestion holds

Textmetadata
LicenceTDM
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.