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

Table 1 Case study: the ‘On-demand Nexium Evaluation’ (ONE) trial ^a

Key characteristics of seeding trials[7–9]	Does this apply for the ONE trial?
Tests a new drug recently or about to be licensed	Yes: application year 2000, study completed by the end of 2001; esomeprazole licensed in 2001
Many well established competing products	Yes: omeprazole from 1989, lansoprazole and pantoprazole from 1995
Many patients included	Yes: 2,500 patients (the trial with most Norwegian patients to be included). In addition, similar studies have been conducted in other countries (see main text).
Frequent prescribers in the role of clinical investigators	Yes: 402 general practitioners (GPs; the study involving most Norwegian GP investigators)
Often redundant as they are not designed for answering a scientific problem	Probably yes
Unreasonably high payments for the investigators	No: €750 which is below the 25th percentile for all trials
Results are often not published	No: there were three publications
Conducted by drug company marketing departments	Unknown

^aFull trial title: ‘Long-term treatment of patients with symptomatic gastroesophageal reflux disease (GERD) comparing costs and efficacy over six months of treatment with esomeprazole 20 mg q.d on demand treatment or esomeprazole 20 mg q.d continuous treatment or ranitidine 150 mg b.i.d. continuous treatment. An open, randomised, multicenter study. On-demand Nexium Evaluation - ONE’. Sponsor: AstraZeneca.

ISSN: 1745-6215