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

Brænd, Anja Maria; Jensen, Kaspar Buus; Klovning, A.; Straand, Jørúnd

doi:10.1186/1745-6215-14-162

Cited by 8 publications

(11 citation statements)

References 34 publications

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“…Of these trials, 189 were industry initiated (ie, funded or conducted by a pharmaceutical company), 182 were multinational, and the total planned sample size (all countries) was over 330 000 patients. 12 A majority (151 trials) had trial sites in both general practice and specialist care settings. According to the protocols, the trials were planned to be completed between 1998 and 2012.…”

Section: Methodsmentioning

confidence: 99%

“…The identification and selection of trial protocols have been described in more detail elsewhere. 12 …”

Section: Methodsmentioning

confidence: 99%

“…The vast majority of drug trials in general practice are conducted by the pharmaceutical industry; however, few trials are conducted solely in general practice. 12 General practitioners (GPs) invited by a pharmaceutical company to participate in a trial may sometimes find it hard to differentiate between a trial primarily designed for marketing and a sound scientific trial. It has been claimed that drug trials mainly designed for marketing, so-called ‘seeding trials’, may explain the more frequent use of expensive antihypertensive drugs in Norway compared with the UK.…”

Section: Introductionmentioning

confidence: 99%

“…Although many clinical drug trials take place in general practice, 12 non-publication of clinical trial results in this setting has only rarely been investigated. In an audit of general practice drug trials in the UK from 1984 to 1989, Wise and Drury found that 63% of completed trials were not published.…”

Section: Introductionmentioning

confidence: 99%

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Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

et al. 2016

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ObjectivesPreviously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998–2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported.DesignCohort study of trials with systematic searches for published results.SettingClinical drug trials in Norwegian general practice.MethodsWe performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications.Main outcome measuresWe determined the frequency of publication of trial results and trial characteristics associated with publication of results.ResultsOf the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ2 test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers.ConclusionsWe did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published.

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Section: Methodsmentioning

confidence: 99%

“…The identification and selection of trial protocols have been described in more detail elsewhere. 12 …”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

et al. 2016

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“…Despite the fact that the majority of patients with COPD are treated in primary care, clinical research on COPD concentrates on secondary or tertiary care, leaving the majority of the affected population underrepresented in trials [17,18,19]. Moreover, the selection criteria for COPD commonly used in trials admit only a minority of the affected population, and their representativeness of ‘real-life' COPD patients has been questioned as well [20].…”

Section: Introductionmentioning

confidence: 99%

The Impact of Case Finding on the Recruitment Yield for COPD Research in Primary Care: An Observational Study

Markun¹,

Rosemann²,

Dalla-Lana³

et al. 2016

Respiration

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Background: Recruiting patients for research in primary care is difficult with diseases that tend to remain underdiagnosed, such as chronic obstructive pulmonary disease (COPD). Researchers may consider introducing case finding into patient recruitment, but the impact on recruitment yield is largely unknown. Objectives: To assess the impact of case finding on recruitment yield and population characteristics in primary care-based COPD research. Methods: For a cluster randomized controlled trial of COPD in primary care, an opportunistic case finding strategy was introduced into patient recruitment, in addition to recruiting patients with previously diagnosed COPD. The recruitment process and performance of the primary care physicians (PCPs) were analysed. The numbers and characteristics of patients identified by case finding were compared with those of patients with previously diagnosed COPD. Results: Thirty-five PCPs approached 398 patients and successfully recruited 216 patients during 1 year. The mean number of patients recruited was 6.3 (range 0-16) per PCP. Case finding contributed 71 patients (32.9%) with significantly milder disease, with FEV₁ % predicted +16.7 (95% CI: +11.3 to +22.0), a COPD Assessment Test difference of -4 points (95% CI: -2 to -6; p < 0.001), and fewer exacerbations resulting in a higher rate of GOLD class A (85.9 vs. 45.5%; p < 0.001). The smoking rate was significantly higher among patients with newly diagnosed COPD (70.4 vs. 48.6%; p = 0.002). Conclusion: Case finding increased the number of patients recruited by 50%. The COPD patients identified by case finding differed importantly from those with previously diagnosed COPD. Researchers should be aware of COPD underdiagnosis and the potential impact of case finding during patient recruitment.

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Medizinische Autorität und Interessenkonflikt: Content is King

Herold

2018

Institutionelle Korruption Und Arzneimittelvertrieb

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

Cited by 8 publications

References 34 publications

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

The Impact of Case Finding on the Recruitment Yield for COPD Research in Primary Care: An Observational Study

Medizinische Autorität und Interessenkonflikt: Content is King

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