巻号一覧
45 巻 (2014)
- 6 号 p. 209-
- 5 号 p. 179-
- 4 号 p. 123-
- 3 号 p. 71-
- 2 号 p. 39-
- 1 号 p. 3-
45 巻, 2 号
選択された号の論文の5件中1～5を表示しています
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特集／ヘルシンキ宣言2013年改訂
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越前 宏俊2014 年 45 巻 2 号 p. 39
発行日: 2014/03/31
公開日: 2014/04/16
ジャーナル フリーPDF形式でダウンロード (562K) -
栗原 千絵子2014 年 45 巻 2 号 p. 41-51
発行日: 2014/03/31
公開日: 2014/04/16
ジャーナル フリーThe latest revision of the Declaration of Helsinki was adopted by the World Medical Association (WMA) in October 2013. The year 2014 is the 50th anniversary since the first adoption of the Declaration in 1964, which was based on strong reflection over the unethical human experimentation conducted by doctors during World War II. Subsequently, the WMA has continuously elaborated the Declaration with the goal to prevent abuse of human dignity, and to guide physicians worldwide toward the conduct of ethically and scientifically sound research involving human subjects, to adhere to their duty of working for the patients' best interest.
The most remarkable points discussed toward this 2013 revision are: (1) adding subheadings; (2) creating a provision to assure compensation and treatment for subjects harmed as a result of research; (3) clarifying the provisions of comparators e.g., placebo; (4) clarifying the provisions of protecting vulnerable populations and post-study arrangement; (5) adding the concept of biobank in the provision of research using human material and/or data; (6) strengthening the function of research ethics committees; (7) expanding the range of research to be registered in public database; and (8) clarifying the provision of the use of unproven intervention.
There remain pros and cons of the principles in the revised Declaration; however, it is important to understand the historical background and continuing debates regarding the Declaration as a "living document". In this paper, the author describes such discussions that are believed to promote profound understanding of this document, which are necessary for the research communities in the world to conduct ethically and scientifically sound research involving human subjects.抄録全体を表示PDF形式でダウンロード (744K) -
2014 年 45 巻 2 号 p. 53-58
発行日: 2014/03/31
公開日: 2014/04/16
ジャーナル フリーPDF形式でダウンロード (756K)
原著
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古川 衣登, 成川 衛2014 年 45 巻 2 号 p. 59-62
発行日: 2014/03/31
公開日: 2014/04/16
ジャーナル フリーTo obtain approval for new indications of existing drugs, companies usually need to conduct clinical trials to show the efficacy and safety for the indications. There exists a special scheme called "Kouchi-shinsei" (public knowledge-based application) in which companies can apply for approval without conducting additional clinical trials, if efficacy and safety for the new indication are recognized to be publicly known in the medical and pharmacological field through publications. Based on "Kouchi-shinsei", 170 compounds/116 indications have been approved. During the review process of these compounds/indications, active cooperation of academic societies and reinforcement of evidence by the regulatory authority were observed. In order that this scheme will be used effectively and continuously, further cooperations among pharmaceutical industry, regulatory authority, and academic societies are needed.抄録全体を表示PDF形式でダウンロード (652K) -
Masao NAKAMURA2014 年 45 巻 2 号 p. 63-69
発行日: 2014/03/31
公開日: 2014/04/16
ジャーナル フリーIn comparing many different results such as the levels of significance and changes from baseline to endpoint within treatment group as well as between groups, displaying a number of tables and figures with p values is sometimes useful. Presenting results in this manner, however, is not a user-friendly way to identify trends and patterns for complicated results. We, therefore, developed the NMatrix, a method of presentation using a simple matrix table that allows researchers to concisely summarize multiple differences and to simultaneously make multiple assessments. To demonstrate the usefulness of the NMatrix, the results of statistical analyses of QOL assessed by the Roland-Morris Disability Questionnaire in Japanese patients with back pain were presented with the NMatrix, using data collected in two clinical studies. The result of our study suggests the usefulness of the NMatrix in concisely summarizing the results of statistical analyses, using multi-item instruments. In addition, some appropriate multiplicity adjustment should be made if necessary, when presenting some results of statistical analyses using the NMatrix.抄録全体を表示PDF形式でダウンロード (1449K)
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