Programme no. 151-P
Reporting of results from clinical drug trials in Norwegian general practice
Anja Maria Brænd*1, Atle Klovning2, Jørund Straand3
1Department of General Practice,University of Oslo,Oslo,Norway, 2Department of General Practice,University of Oslo,Oslo,Norway, 3Department of General Practice,University of Oslo,Oslo,Norway
* = Presenting author
Objectives: The aim of this study was to identify clinical drug trials in Norwegian general practice over a 10-year period, and examine this cohort of trials for publications, public registration and methodological characteristics.
Background: Reporting of results is important to avoid publication bias and unnecessary replication of research. Clinical drug trials in general practice are mainly conducted by the pharmaceutical industry.
Results: We identified 196 trials in the cohort of trials, of which 189 were industry-initiated. The trials were planned to be completed from 1998 to 2012. Half of the trials were registered at www.clinicaltrials.gov, most of these had application year 2003-2007. For about one third of the trials we did not find any published results. Results with methodological characteristics of the publications and information about the trials provided by the sponsors will be presented at the congress.
Material/Methods: A cohort of drug trials in Norwegian general practice was previously identified from the Norwegian Medicines Agency archive with year of application for approval 1998-2007. Clinicaltrials.gov was searched for public registration of the trials. Systematic literature searches of Medline, Embase and CENTRAL were performed to identify publications originating from each of these trials using characteristics such as test drug, comparator and patient groups as search terms. Author information and methodological characteristics were registered from the publications of the trials. Where no publication was identified, the trial sponsors will be contacted for information of whether the trial had been carried out or not, if there exist any publications not identified by our literature searches, and reasons for either not carrying out the trial or for not publishing results.
Conclusion: For about one third of the drug trials in a cohort of trials in Norwegian general practice no published results were identified, and half of the trials were not registered at clinicaltrials.gov. This may contribute to a deficient medical knowledge base.
Points for discussion:
What impact does publication bias have on clinical decision making in general practice?
How can we make it easier to conduct clinical drug trials in general practice?