| year |
volume |
number |
page |
article's title |
author |
translator |
origin |
| 1974 |
2 |
1 |
125 |
|
Yorio Satoh |
|
|
| 1974 |
2 |
2 |
299 |
|
Controlled Committee |
|
|
| 1974 |
2 |
2 |
313 |
|
Controller Committee |
|
|
| 1975 |
3 |
1 |
99 |
Research, Development, and Demonstration Activities: Limitations of Informed Consent－Special Policy Considerations |
National Institutes of Health |
Tadahio MItsuishi |
Federal Register, Vol.38,No.221, Nov.16,1973 |
| 1975 |
3 |
1 |
99 |
|
Controlled Committee |
|
|
| 1975 |
3 |
1 |
117 |
|
Controller Committee |
|
|
| 1975 |
3 |
2 |
271 |
Research, Development, and Demonstration Activities(2): Limitations of Informed Consent－Special Policy Considerations |
National Institutes of Health |
Tadahiro Mitsuishi |
Federal Register, Vol.38,No.221, Nov.16,1973 |
| 1976 |
4 |
1 |
145 |
On the New Version of The Declaration of Helsinki, as revised 1975 |
Haruo Miyano |
|
|
| 1976 |
4 |
1 |
155 |
What is the significance of the 1975 revision of the 1964 Helsinki Declaration to the freedom and safety of the individual who subjected to clinical research? |
Tadahiro Mituishi |
|
|
| 1976 |
4 |
1 |
161 |
DECLARATION OF HELSINKI, 1964 Revised [Originally 1962] |
The World Medical Association |
|
|
| 1976 |
4 |
1 |
163 |
THE WORLD MEDICAL ASSOCIATION, INC. DRAFT DECLARATION OF HELSINKI Recommendaions guiding medical doctors in biomedical research |
The World Medical Association |
|
|
| 1976 |
4 |
1 |
165 |
Notes on Applications for Manufacturing (or Importing) Approval of New Drugs |
Controller Committee |
|
|
| 1976 |
4 |
2 |
277 |
SCHMIDT TESTIMONY:FDA commissioner addresses sen. Kennedy's subcomte. about the use of human subjects for drug investigation |
ＦＤＡ |
Controller Committee |
DRUG RESEARCH REPORTS "The Blue Sheet" July 23,1975 |
| 1976 |
4 |
2 |
305 |
PMA CLINICAL RESEARCH POLYCY:PMA polycy outlines recommendations for clinical research on human subjects including prisoners and the mentally infirm |
The Pharmaceutical Mfc. Assn. PMA |
Controller Committee |
DRUG RESEARCH REPORTS "The Blue Sheet" July 23,1975 |
| 1976 |
4 |
3 |
549 |
Text of Electronic Data Processing System on Drug Evaluation －Cross-Over Comparison(D5)－ |
Controller Committee |
|
Federal Resister, Nov.19, 1976 |
| 1977 |
5 |
1 |
135 |
Introduction to the Proposed Good Laboratory Practice Regulation(GLP) by FDA |
ＦＤＡ |
Controller Committee |
Federak Resister, Nov.19,1976 |
| 1977 |
5 |
1 |
149 |
FDA Guidelines for Psychotropic Drugs |
ＦＤＡ |
Hitoshi Itoh, Shigeo Kaizawa, Sadanori Miura et al. |
ECDEU intercom Jan. 1975 |
| 1977 |
5 |
2 |
447 |
Influence of Pharmaceutial Industries on Post-graduate Education of Medical Doctors in the United States－With Special Reference to the Statement of FDA BuDirector at House Hearing |
ＦＤＡ |
Controller Committee |
|
| 1977 |
5 |
3 |
687 |
Text of Electronic Data Processing System on Drug Evaluation－Part 1:Inter-Group Comparison (D4)(English Translation)－(English Translation) |
Controller Committee |
|
|
| 1977 |
5 |
3 |
703 |
Guideline to Clinical Trials of Anti-hypertensive Drugs |
Msakuni Kameyama |
|
|
| 1978 |
6 |
1 |
127 |
Evaluation of Hypnotics and Sedative by National Institute of Drug Abuse(USA) |
|
Controller Committee |
|
| 1978 |
6 |
1 |
127 |
Evaluation of Hypnotics and Sedatives by National Institute of Drug Abuse (USA) |
National Institute on Drug Abuse(NIDA) |
Controller Committee |
|
| 1979 |
7 |
2 |
399 |
Obligations of Clinical Investigators of regulated articles |
ＦＤＡ |
Controller Committee |
Federal Resister, Aug.8,1978 |
| 1979 |
7 |
2 |
413 |
General Considerations for the Clinical Evaluation of Drugs |
ＦＤＡ |
|
|
| 1980 |
8 |
1 |
279 |
Guidelines for Clinical Trials of Psychotropic Drugs |
J.R.Wittenborn ed. |
Hitoshi Itoh |
|
| 1981 |
9 |
1 |
229 |
Glossary for FDA Guidelines |
Controller Committee |
|
|
| 1983 |
11 |
3 |
791 |
Development and Approval of Drugs of Foreign Origin in Japan |
Naokata Shimizu |
|
|
| 1984 |
12 |
2 |
557 |
The International Regulatory Acceptability of Clinical Trials |
Chikayuki N.,Schaus J., Baumelou A., Bilstad M, |
Controller Committee |
|
| 1984 |
12 |
2 |
569 |
International Regulatory Comparisons |
Dukes M.N.G., Wardell W.M., Parker J.M., Hass A.E. |
Controller Committee |
|
| 1986 |
14 |
4 |
907 |
Draft Guideline for the Format and Content of the Clinical Data of an Application |
ＦＤＡ |
Controller Committee |
FDA Guideline Draft, Jan.1986 |
| 1987 |
15 |
3 |
601 |
New Drug, Antibiotic, and Biologic Drug Product Regulation－IND Rewrite of FDA－ |
ＦＤＡ |
Controller Committee |
|
| 1989 |
17 |
1 |
141 |
Recommended Basis for the Conduct of Clinical Trials of Medicinal Products in the European Community |
the CPMP Working Party on Efficacy of Drugs |
Controller Committee |
|
| 1989 |
17 |
1 |
155 |
Guidelines on Good Clinical Research Practice |
ABPI |
Controller Committee |
|
| 1989 |
17 |
2 |
323 |
Japanese Good Clinical Practice |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
159 |
Japanese Good Clinical Practice |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
169 |
Manual of Japanese Good Clinical Practice |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
195 |
The Implication and the Importance of Post-marketing Surveillance in Drug Evaluation |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
197 |
Method of the Investigation of the Results of Clinical Experience with Drugs 1987 |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
205 |
Method of the Investigation of the Results of Clinical Experience with Drugs 1988 |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
1 |
217 |
Method of the Investigation of the Results of Clinical Experience with Drugs 1989 |
the Ministry of Health and Welfare |
|
|
| 1990 |
18 |
2 |
381 |
Good Clinical Practice for Trials on Medicinal Products in the European Community |
CPMP Working Party on Efficacy of Medicinal Produc |
|
|
| 1990 |
18 |
3 |
481 |
FDA Approval Requirments for Lipid-Altering Agents |
ＦＤＡ |
Controller Committee |
|
| 1990 |
18 |
3 |
483 |
Study Design and FDA Approval Requirements for Cancer Drugs |
ＦＤＡ |
Controller Committee |
|
| 1990 |
18 |
3 |
485 |
International Adverse Drug Reporting |
ＣＩＯＭＳ |
Controller Committee |
|
| 1990 |
18 |
3 |
491 |
A Brief Introduction for Good Clinical Practice for Trials on Drugs（Good Clinical Practice:ＧＣＰ） |
Tatsuo Kurokawa (Ministry of Health and Welfare) |
|
|
| 1990 |
18 |
3 |
497 |
Good Clinical Practice for Trials on Drugs(Notification) |
Ministry of Health and Welfare |
|
|
| 1990 |
18 |
3 |
513 |
Manual of Good Clinical Practice for Trials on Drugs（ＧＣＰ） |
|
|
|
| 1990 |
18 |
3 |
543 |
Good Clinical Practice for Trials on Medicinal Products in the European Community: Addition and Alteration |
|
|
|
| 1991 |
19 |
1 |
165 |
AmFAR AIDS/HIV Clinical Trial Handbook |
ＡｍＦＡＲ |
Akiea Sakuma |
|
| 1991 |
19 |
1 |
173 |
What Are Clinical Trial All About?－A Booklet for Patients with Cancer－ |
Eleanor Nealon, NCI |
Akira Sakuma |
|
| 1991 |
19 |
2 |
277 |
Standard for Implementation of the Post-Marketing Surveillance for the Reexamination Applications of New Drugs, etc.(Notification) |
Ministry of Health and Welfare |
|
|
| 1991 |
19 |
2 |
291 |
Research Report from the Task Force on an Implementation Method of the Investigation of the Results of Clinical Experience with Drugs; 1990 |
Ministry of Health and Welfare |
|
|
| 1991 |
19 |
3 |
413 |
EC Guideline－Clinical Investigation of Medicinal Products in the Elderly |
|
Keiji Ueda |
EC Guideline |
| 1991 |
19 |
3 |
417 |
FDA Guideline－Guideline for the Study of Drugs Likely to be Used in the Elderly |
|
Keiji Ueda |
FDA Guideline |
| 1992 |
20 |
1 |
205 |
Guidelines Concerning Statistical Analysis of Controlled Clinical Trials |
Ministry of Health and Welfare |
|
|
| 1992 |
20 |
2 |
401 |
General Consideration for the Clinical Evaluation of New Drugs |
Ministry of Health and Welfare |
|
|
| 1992 |
20 |
3 |
543 |
WHO Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products |
Division of Drug Management & Policies WHO |
Keiji Ueda |
WHO Guideline |
| 1992 |
20 |
3 |
563 |
International Guigelines for Ethical Review of Epidemiological Studies |
CIOMS Geneva |
Tadahiro Mituishi |
|
| 1993 |
21 |
1 |
129 |
Government Viewpoint of Clinical Trials |
Robert Temple, FDA |
|
|
| 1993 |
21 |
1 |
141 |
Difficulties in Evaluating Positive Control Trials |
Robert Temple, FDA |
|
|
| 1993 |
21 |
2 |
303 |
Orphan Drugs Regulation: Final Rule |
ＨＨＳ，ＦＤＡ |
Yoshihito Omori |
|
| 1993 |
21 |
3 |
499 |
FDA Final Report of the Committee for Clinical Review Based on a Review of Selected Medical Device Applications |
ＦＤＡ |
Yoshihito Omori |
|
| 1994 |
22 |
1 |
175 |
Medical Device Clinical Study Guidance |
ＦＤＡ |
Yoshihito Omori |
|
| 1994 |
22 |
2,3 |
261 |
International Ethical Guidelines for Biomedical Research Involving Human Subjects |
CIOMS |
Tadahiro Mituishi |
|
| 1995 |
23 |
1 |
121 |
Guideline for the Study and Evaluation of Gender Difference in the Clinical Evaluation of Drugs |
ＦＤＡ |
Naokata Shimizu, Toshio Watabe |
Federal Resister July 22,1993 |
| 1995 |
23 |
1 |
137 |
Present Status of Compliance wtih GCP(Part1)－Results of Questionnaire to Medical Institutions－ |
Keiji Ueda |
|
|
| 1995 |
23 |
2 |
|
ICH・GCP Guideline and Addenda(Draft) |
Ministry of Health and Welfare |
|
|
| 1995 |
23 |
3 |
631 |
Present Status of Compliance with GCP(Part2)－Results of Questionnaire to Chief Investigators－ |
Keiji Ueda |
|
|
| 1996 |
24 |
1 |
79 |
New Analyses Regarding the Safety of Calcium-channel Blockers: A Statement for Health Professionals from the National Heart, Lung, and Blood Institute |
NHLBI |
|
|
| 1996 |
24 |
1 |
85 |
|
Yoshihiro Kaneko |
|
|
| 1996 |
24 |
1 |
87 |
Prospective Randomized Open Blinded End-pont(PROBE) Study －A novel design for intervention trials－ |
Lennart Hansson, et al. |
Yoshihiro Kaneko |
Blood Pressure, 1:113-119,1992 |
| 1996 |
24 |
1 |
95 |
|
Yoshihiro Kaneko |
|
|
| 1996 |
24 |
1 |
97 |
Studies On Improvement Of Package Insert |
Naokata Shimizu |
|
|
| 1996 |
24 |
1 |
117 |
|
Ministry of Health and Welfare |
|
|
| 1996 |
24 |
1 |
125 |
|
Ministry of Health and Welfare |
|
|
| 1997 |
24 |
2,3 |
263 |
A new proposal for benefit-less-risk analysis in clinical trials |
Christy Chang-Stein, PhD. |
Koichi Yamamoto |
Controlled Clinical Trials,15:30-43, 1994 |
| 1997 |
24 |
2,3 |
275 |
A new propozal for benefit-less-risk analysis in clinical traials |
Christy Chang-Stein, PhD. |
Akira Sakuma |
1994 |
| 1997 |
24 |
2,3 |
281 |
comment |
Koichi Yamamoto |
|
|
| 1997 |
24 |
2,3 |
285 |
Studies on facilitation of voluntary reporting by health professions of adverse drug reactions in Japan |
Naokata Shimizu, Yasuo Kozu, Toshitaka Nabeshima |
|
|
| 1998 |
26 |
1 |
89 |
Guideline for Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
[Japanese][English] |
|
|
|
| 1998 |
26 |
1 |
109 |
Genaral Considerations for Clinical Trials |
|
|
|
| 1998 |
26 |
2 |
285 |
Guidelines for the Evaluation of Antidementia Drugs |
FDA |
Yoshihito Omori, Chieko Kurihara |
|
| 1998 |
26 |
2 |
311 |
Note for Guidance on Medicinal Products in the Treatment of Alzheimar's Disease |
CPMP |
Yoshihito Omori, Chieko Kurihara |
|
| 1998 |
26 |
2 |
321 |
Introduction of seven abstracts of Systematic Review of Antidementia Drugs in the Cochrane Database
of Systematic Review |
The Editorial Staff |
|
|
| 1999 |
26 |
3 |
505 |
Conflict of Interest in the Debate over Calcium-Channel Antagonists |
Henry T. Stelfox, M.D., Grace Chua, M.D., Keith O'Rourke, M.B.A., Allan S. Detsky, M.D.,Ph.D. |
Tadahiro Mitsuishi |
N Engl J Med. 1998; 338: 101-106 |
| 1999 |
26 |
3 |
517 |
Ethnic Factors in the Acceptability of Foreign Clinical Data |
The Ministry of Health and Welfare |
|
|
| 1999 |
27 |
1 |
159 |
Statistical Principles for Clinical Trials [Japanese][English] |
The Ministry of Health and Welfare |
|
|
| 1999 |
27 |
2 |
361 |
The Report of the Committee on Appropriate Execution of Clinical Trials |
|
|
|
| 1999 |
27 |
2 |
371 |
Impact of the New GCP Regulation on Clinical Trials in Japan -A Survey of IRB chairs- |
Keiji Ueda, Shunichi Fukuhara, Peter L. Glickman, et al. |
|
|
| 1999 |
27 |
2 |
379 |
Survey of the Performance for Nurse Clinical Research Coordinator |
Toshiko Ibe, Yasuko Tokunaga |
|
|
| 1999 |
27 |
2 |
393 |
Medical Statistics as Viewed from the Perspective of Value of Information |
Tenri Institute of Medical Research (Chief; Maetani S) |
|
|
| 1999 |
27 |
2 |
409 |
Double-blind Trial of Intravenous and Subcutaneous Administrations of Recombinant Human
Erythropoietin (SNB-5001) for Anemia in Hemodialysis Patients (Revised Article) |
Shozo Koshikawa, Kazuo Ota, Yasushi Asano, et al. |
|
|
| 2000 |
28 |
1 |
153 |
Guidance for industry: Providing clinical evidence of effectiveness for human drug and biological products |
FDA/CDER & FDA/CBER |
Tsutani K, Usuki H |
|
| 2001 |
28 |
3 |
527 |
Declaration of Helsinki |
World Medical Association |
Japan Medical Association |
|
| 2001 |
28 |
3 |
531 |
Choice of control group in clinical trials |
Notification from Evaluation and Licensing Division, Pharmceutical and Medical Safety Bureau, Ministry of Health, Labor and Welfare |
|
|
| 2001 |
28 |
3 |
559 |
The Belmont Report |
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research |
Tsutani K, Mitsuishi T, Kurihara C |
|
| 2001 |
29 |
1 |
203 |
Sponsorship, authorship, and accountability |
Davidoff F, et al. |
Kurihara C, Mitsuishi T |
NEJM 2001; 345: 825-7 |
| 2002 |
29 |
2･3 |
303 |
Britain's gift: a "Medline" of synthesized evidence: Worldwide free access to evidence based resources could transform health care |
Richard Smith, Iain Chalmers |
Saio T |
BMJ 2001; 323: 1437-8 |
| 2002 |
29 |
2･3 |
367 |
Relation between clinical trial's process and compliance review |
Editorial Committee |
|
|
| 2002 |
29 |
2･3 |
368 |
Services concerning compliance review for new drugs of OSPR |
Editorial Committee |
|
|
| 2002 |
30 |
1 |
135 |
Code de la Sante Publique Premiere Parti, Livre Ier Titre II. Recherches biomedicales |
|
Mitsuishi T, Nudeshima J, Kurihara C |
|
| 2002 |
30 |
1 |
143 |
Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment |
Hrobjartsson A, Gotzsche PC |
Kobayashi T, Kurihara C, Tsutani K |
NEJM 2001; 344(21): 1594-602 |
| 2002 |
30 |
1 |
159 |
The powerful placebo and the wizard of Oz |
John C. Bailar III |
Kobayashi T, Kurihara C, Tsutani K |
NEJM 2001; 344(21): 1630-2 |
| 2002 |
30 |
1 |
163 |
The revised CONSORT statement for reporting randomized trials: Explanation and elaboration |
Altman DG, Schulz KF, Moher D, et al. |
Tsutani K, Kurihara C |
Ann of Intern Med 2001; 134(8): 663-94 |
| 2003 |
30 |
2･3 |
397 |
Report on the developments of the Dutch system for medical ethical review |
Marcel JH Kenter |
Uchida N, Uchida E |
The EFGCP News |
| 2003 |
31 |
1 |
59 |
The Committee Report on standard principle of the utilization of SMO |
Ministry of Health, Labour and Welfare |
|
|
| 2003 |
31 |
1 |
69 |
Relation between CRO and SMO-Proper attitude of CRO and SMO- |
Japanese CRO Association |
|
|
| 2003 |
31 |
1 |
75 |
Ethical guidelines for clinical research |
Ministry of Health, Labour and Welfare |
|
|
| 2003 |
31 |
1 |
141 |
The participant's continuing consent and the roles of doctors, sponsors, IRBs, and supporting organizations |
Okamoto T, Kurihara C |
|
|
| 2003 |
31 |
1 |
145 |
Consent for continuing research participation: What is it and when should it be obtained? |
Dave Wendler, Jonathan Rackoff |
Okamoto T |
IRB: Ethics & Human Research 2002; 24(3): 1-6 |
| 2003 |
31 |
1 |
153 |
Explanation of the translation of the article "Standardized reporting of clinical practice guidelines" |
Saio T, Mitsuishi T |
|
|
| 2003 |
31 |
1 |
157 |
Standardized reporting of clinical practice guidelines: A proposal from the Conference on Guideline Standardization |
Shiffman RN, Shekelle P, et al. |
Saio T, Mitsuishi T |
Ann Intern Med 2003; 139: 493-8 |
| 2003 |
31 |
1 |
169 |
Report on a study of the present status of unapproved drug use in Japan, including thalidomide |
|
|
|
| 2004 |
31 |
2 |
423 |
Concerning legal control on medical research involving incapable adults in the Adults with Incapacity (Scotland) Act 2000 |
Mitsuishi T |
|
|
| 2004 |
31 |
2 |
485 |
Common Operational Guideline for the Ethical Review of Translational Research |
Asano S, Iwamoto A, Tahara H, et al. |
|
|
| 2004 |
31 |
3 |
629 |
Is the ethical imperative of informing study participants of research results realized in Japan? |
Okamoto T, Kurihara C |
|
|
| 2004 |
31 |
3 |
635 |
Informing Study Participants of Research Results: An Ethical Imperative |
Fernandez CV, Kodish E, Weijer C |
Okamoto T |
IRB: Ethics & Human Research 2003; 25(3): 12-9 |
| 2004 |
31 |
3 |
647 |
TREND statement: to promote evidence-based public health |
Saio T, Fujita T |
|
|
| 2004 |
31 |
3 |
649 |
Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement |
Des Jarlais DC, Lyles C, Crepaz N, the TREND group |
Saio T, Fujita T |
AJPH 2004; 94(3): 361-6 |
| 2005 |
32 |
1 |
271 |
Review: 2004 Revision of the French Human Research Participants Protection Act |
Nudeshima J |
|
|
| 2005 |
32 |
1 |
285 |
Code de la Sante Publique Premiere Parti, Livre Ier Titre II. Recherches biomedicales |
|
Nudeshima J |
|
| 2005 |
32 |
1 |
297 |
"Number needed to screen" as an application of the F method: understanding diverse indicators derived from "number needed to treat" |
Saio T, Fujita T |
|
|
| 2005 |
32 |
1 |
301 |
Number needed to screen: development of a statistic for disease screening |
Rembold CM |
Saio T, Fujita T |
BMJ 1998; 317: 307-12 |
| 2005 |
32 |
1 |
311 |
FDA Pharmacogenomics Guidance: Impact on drug development |
Ronald A. Salerno |
Azuma J, Katoh K |
|