●Editorial | Nomoto M | 169 | Full text | |
●The 12th Setouchi International Conference on Clinical Trials / The 32nd Aso-Kujyu Conference on Clinical Pharmacology | 171-230 | Abstract | ||
Organized by: Clinical Research Trial Center, Ehime University Hospital | ||||
Opening remarks | Nomoto M | 174 | ||
Accelerating regulatory science initiative | Miyata T | 175-82 | ||
Clinical translation of hepatocyte growth factor for amyotrophic lateral sclerosis | Aoki M | 183-9 | ||
Challenges in the academic institution | Moritoyo T | 190-7 | ||
What can the Pharmaceutical Company do in the cooperation of industrial,
administrative and academic sectors in a clinical study? |
Iwasaki K | 198-204 | ||
Collaboration between academia and pharma | Iwasaki M | 205-10 | ||
General discussion | 211-4 | |||
An introduction to Bayesian adaptive design | Lewis RJ | 215-29 | ||
Closing remarks | Nomoto M | 230 | ||
Adaptive designs in clinical trials: An overview | Origasa H | 231-40 | Abstract | |
●Medical Innovation Management and the trend of data standardization | ||||
Medical Innovation Management: Principle and Practice | Fukushima M,editor. | 241-394 | Full text | |
The comment on FDA draft guidances about regulatory submissions in electronic format-standardized study data | Jyouno T | 395-402 | Abstract | |
Guidance for Industry: Providing Regulatory Submissions in Electronic
Format- Standardized Study Data[draft guidance] | FDA-CDER,CBER (trans. by Jyouno T) | 403-10 | ||
●World trend of ethics and science of clinical trial | ||||
Interview with Dr. Robert Temple on drug evaluation policy of FDA | Temple R,et al. | 411-23 | Full text | |
The WMA Council Session in Tokyo, 2014: Globalized medical ethics and research ethics | Mungherera M,et al. | 425-57 | Full text | |
Challenges in regulating biomedical research: The Human Subjects Research Act and the Human Biobank Management Act in Taiwan | Chen I | 459-66 | Abstract | |
Trend of research ethics and conflict of interest management in Korea and Taiwan | Kurihara C | 467-84 | Full text | |
Reformation of clinical trial regulations in European Union (EU) | Kurihara C | 485-500 | Full text | |
●Instructions for authors[Japanese]&[English] | 501-9 | Full text | ||
●Editor’s note | Kawai S | 511 | Full text | |
[Electronic publications only] | ||||
●Articles | ||||
Publication denied: A case analysis of infringement of publication integrity and ethics | Matsui K,et al. | 513-7 | Full text | |
Analyzing the development of ethics guidelines for nursing research in Japan | Matsui K,et al. | 519-30 | Full text | |
●Forum | ||||
Open dialogue approach to acute psychosis | Saio T | 531-7 | Full text | |
●English versions of articles in Japanese | ||||
Interview with Dr. Robert Temple on drug evaluation policy of FDA | Temple R,et al. | 539-51 | Full text | |
The WMA Council Session in Tokyo, 2014 | Mungherera M,et al. | 553-90 | Full text | |
Trend of research ethics and conflict of interest management in Korea and Taiwan | Kurihara C | 591-610 | Full text |