Evidence map›Paper›PMID 31583338›Full record

ArticlePain reports

Designing and conducting proof-of-concept chronic pain analgesic clinical trials.

Claudia M Campbell, Ian Gilron, Tina Doshi, Srinivasa Raja

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pain reports. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  10. Can we characterize A-P/IAP behavioural phenotypes in people with chronic pain?Frontiers in pain research (Lausanne, Switzerland) · 2023
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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

4 authors.

Claudia M CampbellDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.
Ian GilronDepartments of Anesthesiology & Perioperative Medicine and Biomedical & Molecular Sciences, Queen's University, Kingston, ON, Canada.
Tina DoshiDivision of Pain Medicine, Johns Hopkins University, Department of Anesthesiology and Critical Care Medicine, Baltimore, MD, USA.
Srinivasa RajaDivision of Pain Medicine, Johns Hopkins University, Department of Anesthesiology and Critical Care Medicine, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe evolution of pain treatment is dependent on successful development and testing of interventions. Proof-of-concept (POC) studies bridge the gap between identification of a novel target and evaluation of the candidate intervention's efficacy within a pain model or the intended clinical pain population.

methodsThis narrative review describes and evaluates clinical trial phases, specific POC pain trials, and approaches to patient profiling.

resultsWe describe common POC trial designs and their value and challenges, a mechanism-based approach, and statistical issues for consideration.

conclusionProof-of-concept trials provide initial evidence for target use in a specific population, the most appropriate dosing strategy, and duration of treatment. A significant goal in designing an informative and efficient POC study is to ensure that the study is safe and sufficiently sensitive to detect a preliminary efficacy signal (ie, a potentially valuable therapy). Proof-of-concept studies help avoid resources wasted on targets/molecules that are not likely to succeed. As such, the design of a successful POC trial requires careful consideration of the research objective, patient population, the particular intervention, and outcome(s) of interest. These trials provide the basis for future, larger-scale studies confirming efficacy, tolerability, side effects, and other associated risks.

Indexed as

ACTTIONClinical trialPainProof-of-conceptQuantitative sensory testing, Pain testing, Personalized medicine

Identifiers

PMID31583338
PMCPMC6749910

What OpenQuestion holds

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Registered trials

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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.