Attitudes regarding informing clinical study result to participants in Japan

e19557 Background: Informing the participants about study result is increased demand in recent years. Some studies reported that almost all participants want to receive study result. However, how much information do participants want and how do researcher offer were not mentioned. Moreover there were concerned about resource for providing study result and the attitude regarding informing result to participants in Japan was not studied. The purpose of this study was aimed to discuss and propose the way of informing study results to Japanese participants. Methods: Summarizing study result and a self-administrated questionnaire survey were conducted. Summary was created from abstract of academic paper with lay language and illustration using color. Objective study was Oral Uracil and Tegafur Compared With Classic Cyclophosphamide, Methotrexate, Fluorouracil As Postoperative Chemotherapy in Patients With Node-Negative, High-Risk Breast Cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial “N-SAS-BC01 trial”(J Clin Oncol 2009). Objective subject was participants of N-SAS-BC01 trial in National Cancer Center Hospital. A cross table and inductive analyze were performed. Results: Summary of result was made A4 (letter size) form 4sheet. 58 patients responded to questionnaire of 116 patients (50%). In 58 responders, 92% of them preferred to be informed of the result. About 80% of responders answered that summary was clear to understand and 30% of them reported that the document should contain more information. The way of receive result preferred by the mail. When the result included bad news, 67% of responders wanted to receive result; on the other hand, three patients answered that they would not to receive because of psychological harmful influence. Conclusions: These answers suggested that participants in Japan desired to inform study result. Therefore, Clinical study result should be provided participants whenever it takes time to get results, including bad news in a careful way. Summary of result should be created using lay language and illustration. Planning the cost, keeping participant contact list, and noticing participants that study result would be informed were needed at the start of the study.