臨床薬理
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
47 巻, 6 号
選択された号の論文の4件中1~4を表示しています
原著
  • 内山 吉彬, 川﨑 洋平, 井出 和希, 野口 真里茄, 曽我 俊幸, 山田 浩
    2016 年 47 巻 6 号 p. 209-217
    発行日: 2016/11/30
    公開日: 2016/12/16
    ジャーナル フリー

    The importance of biostatistical consultations in clinical research to improve the research quality in academic institutions has been addressed. However, the current status of biostatistical consultation in Japan, especially in local hospitals, remains unclear. We conducted a survey of 27 hospitals participating in the Shizuoka Clinical Trial Network, a local hospital network in Shizuoka, from August 10 to November 31, 2015. The questionnaire was sent using postal mail and mainly inquired the current status of statistical consultation and the needs of consultation. Among 27 hospitals, 22 (81.5%) responded to the survey. Five of 22 hospitals (22.7%) provided biostatistical consultation, and the service was provided by one staff member in 4 of 5 hospitals (80.0%). Eleven of 17 hospitals (64.7%) that did not provide biostatistical consultation answered that the consultation service was required. For the question on why biostatistical consultation service was currently not provided, one of the most frequently selected answers was “staff shortage” (23.5%). The study revealed that there exists a need for biostatistical consultation in local hospitals. However, there are several problems such as staff shortage. In addition to improving the service of each hospital, the development of human resources and the establishment of a system for biostatistical consultation using hospital network may be effective to resolve the problems.

  • Chieko KURIHARA, Junko HOSHI, Chieko SUZUKI, Kazuko SUZUKI, Hiroi KASA ...
    2016 年 47 巻 6 号 p. 219-228
    発行日: 2016/11/30
    公開日: 2016/12/16
    ジャーナル フリー

    Introduction: The recent revision of the Declaration of Helsinki strengthened the ethical obligation to provide compensation for harm of research subjects. However, the actual status of providing compensation has rarely been disclosed, especially in the situation of investigator-initiated clinical trials (IITs).

    Objectives: To figure out the actual situation of compensation for injured subjects of IITs in Japan and to identify the necessary steps to fulfill the ethical obligation of compensation.

    Method: We conducted two types of surveys of compensation in IITs in Japan over the past five years. A: questionnaire survey delivered to 1,700 institutions on (1) number and paid amount of compensation cases; number and amount of contract fees paid to insurance companies; and (2) institutional management system of compensation cases. B: complementary survey to the item (1) of the survey A, at two institutions, on contract fees paid to and insurance paid from insurance companies.

    Result: In the survey A, we found only two cases of compensation provided, but could not find any serious cases claiming payment from insurance companies, although we could not exclude possibility of undisclosed cases. In the survey B, at the two institutions, a substantial amount of contract fees has been paid to insurance companies without claiming insurance payment; however, the total amount for each institution is less than that expected for one case of a serious injury. Also we found that there remain several points to improve the institutional management system of compensation in IITs in Japan.

    Conclusion: To provide appropriate compensation for injured subjects of IITs, we need to develop an institutional management system, along with a system to gather statistical information of compensation cases, to achieve proper resource allocation. This system should also provide education for investigators and support staff to manage injury cases.

  • Kazuki IDE, Hiroshi YAMADA, Norikata TAKUMA, Yohei KAWASAKI, Haruka MO ...
    2016 年 47 巻 6 号 p. 229-234
    発行日: 2016/11/30
    公開日: 2016/12/16
    ジャーナル フリー

    The objective of this study is to explore the effects of catechin-treated face masks on influenza prevention. We conducted a randomized controlled study in Japan. Participants included workers in a nursing home, a rehabilitation facility, and a hospital. Participants were randomly allocated into the catechin-treated (epigallocatechin gallate-treated) or non-treated face mask groups for 60 days from January to March, 2016. Incidence of laboratory-confirmed influenza infection was measured and compared between groups using Fisher's exact test. Multivariate analysis was performed to calculate adjusted odds ratios (OR) and associated 95% confidence intervals (CI). After the recruitment of participants, 234 participants were eligible for the study (catechin group, n=118; control group, n=116). Six participants in the full analysis set contracted influenza (catechin: 3.39%; 95% CI: 0.95-5.50%; control: 1.72%; 95% CI: 0.21-6.09%), and the incidence between the groups did not differ significantly (P=0.68). Multivariate analysis showed a similar trend (adjusted OR: 2.35; 95% CI: 0.40-13.72; P=0.34). Our results suggest that the use of catechin-treated face masks does not reduce influenza incidence compared with standard masks. Several limitations to the study, such as infection rates and the selected population may be responsible. Future studies will need to resolve these limitations to accurately evaluate these effects.

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