Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field.
1. A survey has been conducted amongst 459 members of the Clinical Section of the British Pharmacological Society to ascertain facts about the administration of drugs to healthy volunteers over the period October 1986 to September 1987. 2. A response rate of 87.1% was obtained with 114 individuals being involved in healthy volunteer studies. After exclusion of duplicate returns from the same unit 98 questionnaires were analysed. 3. Drugs were given in the year under review to 8163 healthy volunteers for research purposes. Minor adverse effects were reported in 565 (6.9%), moderately severe adverse effects in 45 (0.55%) and potentially life threatening adverse effects in 3 (0.04%). No lasting sequelae were reported. 4. Drugs were given to 7607 healthy student volunteers as part of class teaching practicals. Minor adverse effects were reported in 6.0% of student exposures but no moderately severe or life threatening adverse effects were reported. 5. The risk involved in healthy volunteer studies is very small indeed but some suggestions are made as a result of the questionnaire to improve further the safety of these studies.
Orme
M
M
Department of Pharmacology and Therapeutics, University of Liverpool.
Harry
J
J
Routledge
P
P
Hobson
S
S
D004341:Drug Evaluation / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D004992:Ethics, Medical; D006801:Humans; D010601:Pharmacology, Clinical / Q000193:education; D013334:Students; D006113:United Kingdom