Evidence map›Paper›PMID 21904102›Full record

ReviewPostgraduate medicine2011

Key concepts of clinical trials: a narrative review.

Craig A Umscheid, David J Margolis, Craig E Grossman

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Postgraduate medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 161 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
161citing papers in PubMed, 10 pooled it
–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

161 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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  5. A Systematic Review of Methods to Incorporate External Evidence into Trial-Based Survival Extrapolations for Health Technology Assessment.Medical decision making : an international journal of the Society for Medical Decision Making · 2023
    Pooled it
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  11. Trial
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101 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

3 authors.

Craig A UmscheidCenter for Evidence-Based Practice, University of Pennsylvania, Philadelphia, PA, USA.
David J Margolis
Craig E Grossman

Funding

RADIATION BIOLOGY TRAINING GRANTT32CA009677 · NCI · UNIVERSITY OF PENNSYLVANIA · PI KENNEDY, ANN R · 1992 to 2011
$5.0M
NCI NIH HHS T32 CA009677NCI NIH HHS T32-CA-009677PHS HHS T32-HP-010026
6 · The paper itself

Abstract

The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform.

Indexed as

Randomized Controlled Trials as TopicClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicDrug EvaluationHumansUnited States

Identifiers

PMID21904102
PMCPMC3272827

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.