Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan

Abstract

BackgroundAlthough the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.AimsThe objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.MethodUsing a cross-sectional design, we recruited patients (n = 251) aged 47.7±13.2 (mean±SD) with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.ResultsThe results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.ConclusionsFewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

Factors influencing the willingness to participate in medical research: a nationwide survey in Taiwan

“…Notably, the negative effect of education level on participation in medical research is contrary to most of the findings from previous studies conducted in other countries ( Bouida et al, 2016 ; Brewer et al, 2014 ; Brown & Moyer, 2010 ; Cobb, Singer & Davis, 2014 ; Davis et al, 2013 ; Robinson, Ashley & Haynes, 1996 ). Our findings are also somewhat different from the results of the three studies conducted in South Korea and Japan, in which the researchers had found no association between education level and participation, and no association between marital status and participation in clinical trials ( Chu et al, 2015 ; Kim et al, 2008 ; Sugawara et al, 2015 ). Such discrepancies might be due to the difference between study population of each study.…”

“…Such discrepancies might be due to the difference between study population of each study. For example, the two studies in Korea and Japan recruited their study participants from hospital patients, and not from general population ( Kim et al, 2008 ; Sugawara et al, 2015 ). Another explanation might be the trust in doctors.…”

“…After reviewing past literatures, we found studies that involved large samples of Asian people to assess their participation in medical research and to determine the influencing factors were limited ( Chu et al, 2015 ; Kim et al, 2008 ; Sugawara et al, 2015 ). Therefore, the purpose of this study was to examine how demographic background and trust in medical research affect the willingness to participate in medical research in Taiwan.…”

Placebo effects in adult and adolescent patients with schizophrenia: combined analysis of nine RCTs

“…Placebo response is a complex phenomenon. The regional differences that we observed may have stemmed from a variety of factors, including clinical trial settings, trust in research clinicians, and attitudes toward clinical trials in general .…”

Surveys of clinician and patient attitudes to an add‐on for in vitro fertilisation

“…9 This proportion was significantly higher than other surveys in Japan where willingness to participate was only ~30%. 10,11 However, feasibility surveys for a placebo-controlled endometriosis trial in the United States indicate a surprisingly high (90%) agreement to participate. 12 These disparate findings may reflect the daily impacts of the condition being treated, and the perceived effectiveness of treatment, but may also be influenced by cultural differences between the countries.…”