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[Clinical trials--viewpoints from participants].

Authors :
Langslet G
Ottestad I
Retterstøl K
Ose L
Source :
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke [Tidsskr Nor Laegeforen] 2010 Aug 26; Vol. 130 (16), pp. 1606-8.
Publication Year :
2010

Abstract

Background: In relation to the large number of clinical trials performed, little is written about how the study subjects have experienced their participation. The article presents the results from a questionnaire survey among participants in 18 clinical trials undertaken at the Lipid Clinic, Rikshospitalet, Norway in 2005 and 2006.<br />Material and Methods: A study-specific questionnaire was developed and comprised 17 questions about study participation. Response was anonymous. Results are given as percentage distribution of answers.<br />Results: 56 % (287 persons) completed the questionnaire. Motivation for study participation was twofold, both personal health gains and the desire to contribute to research and development are important motives. 28 % [corrected] thought the new drug could be beneficial for them. Study participants responded the following: 90 % meant that the risk of adverse events and harmful effects of the study drug was small, 73 % that follow-up was good, 85 % that they had received sufficient information about the study and 77 % that study participation had no disadvantages. 73 % thought it had a positive health impact for them to be involved in the study.<br />Interpretation: Participants in our clinical trials are concerned about their own health, but they also want to contribute to research for the well-being of others. Study participants seem to overestimate the health benefits associated with use of the study drug. Frequent medical follow-up and guidance in diet and lifestyle are benefits associated with participation in clinical studies, but the effects are difficult to measure.

Details

Language :
Norwegian
ISSN :
0807-7096
Volume :
130
Issue :
16
Database :
MEDLINE
Journal :
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke
Publication Type :
Academic Journal
Accession number :
20805857
Full Text :
https://doi.org/10.4045/tidsskr.09.0030