Evidence map›Paper›PMID 23725228›Full record

ArticleTrials2013

Clinical drug trials in general practice: a 10-year overview of protocols.

Anja Maria Brænd, Kaspar Buus Jensen, Atle Klovning, Jørund Straand

Abstract read
In one paragraph

Article in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
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.

Anja Maria BrændDepartment of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway. ambraend@medisin.uio.no
Kaspar Buus Jensen
Atle Klovning
Jørund Straand

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDrugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade.

methodsThe present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail.

resultsOut of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%). One trial, presented in more detail, had several characteristics of a seeding or marketing trial.

conclusionsOnly one in four drug trials involving general practice were solely general practice trials and almost all were industry initiated without input from academic general practice. There was a large variation in the number of patients, participating doctors, and economic compensation for trial investigators, with some investigators receiving substantial payments.

Indexed as

General PracticeResearch DesignClinical Trials as TopicCompensation and RedressDrug IndustryHumansIncomeMulticenter Studies as TopicNorwayPatient SelectionPrescription DrugsResearch Support as TopicRetrospective StudiesSample SizeTime FactorsTreatment OutcomePrescription Drugs

Identifiers

PMID23725228
PMCPMC3672091

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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.