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

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

doi:10.1186/1745-6215-14-162

Anja Maria Brænd, Atle Klovning + Show 2 more

Open Access

https://doi.org/10.1186/1745-6215-14-162

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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.

Highlights

Drugs predominantly prescribed in general practice should ideally be tested in that setting; little is known about drug trials in general practice
Some Norwegian data regarding clinical drug trials have previously been reported, based on research applications submitted to the Research Ethical Committees (REC) [12,13,14] and the Norwegian Medicines Agency (NoMA) [15,16]
Only one-tenth of all clinical drug trials in Norway involved patients recruited from general practice, and just one in four of these trials were solely general practice trials

Summary

Introduction

Drugs predominantly prescribed in general practice should ideally be tested in that setting; 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. If a study population in a drug trial differs significantly from the population where the drug is most likely to be prescribed, the external validity of the trial may be impaired [3]. To avoid this uncertainty, many have argued that more clinical drug trials should. Key characteristics of seeding trials [7,8,9]. Yes: 2,500 patients (the trial with most Norwegian patients to be included). Similar studies have been conducted in other countries (see main text).

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