Recognitional study about patients and caregivers' understanding of clinical trial

ABSTRACT

PURPOSE: International guidelines and national laws have been formulated to protect human subjects in research. Recently, many efforts have been tried to contribute to better awareness and knowledge about the link between quality systems and protection to develop better quality procedures in health research. In this study, to improve the understandings about health research, awareness about health research was evaluated with questionnaires for patients and care-givers in our institute. MATERIALS AND METHODS: 339 persons responded to the questionnaires. 128 persons were patients with mild symptoms and 69 were caregivers. 123 were male and 179 were female. Dominant educational level was college graduates and were 166 and economic status was middle-class (247). Questionnaires was composed of 18 items; 7 demographical characteristics items, 7 understanding of clinical trials items, 4 understandings of IRB (Institutional Review Board) concepts items. RESULTS: 71.7% of responder have informations about clinical trials by TV and 23.9% by newspapers. 22.3% have never heard about clinical trials. Knowledge level about clinical trials was thought to be a middle level and subjects of clinical trials were animals (62.5%), patients (54.9%), normal persons (25.4%), plants (11.8%). Objects to be included in clinical trials were pharmaceuticals (62.2%), cell therapy (58.7%), medical device (30.4%), health promotion foods (14.5%). Answer about 'Intention to be the participant" were no in 56% and yes in 34.5%. CONCLUSIONS: Although mass media contributed to the spread of understandings about clinical trials, 22.3% did not know about health research. To improve the awareness and understandings about health research, television (TV) can be the most effective method and the safety about human subject protection should be certified.