[Clinical trials--viewpoints from participants].
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.


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.


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.


CONCLUSIONS
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.
Langslet
Gisle
G
Lipidklinikken, Medisinsk avdeling, Oslo universitetssykehus, Rikshospitalet 0027 Oslo, Norway. gisle.langslet@rikshospitalet.no
Ottestad
Inger
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Retterstøl
Kjetil
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D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000009:adverse effects / Q000523:psychology*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010353:Patient Education as Topic; D010358:Patient Participation / Q000523:psychology*; D012307:Risk Factors; D011795:Surveys and Questionnaires