Rinsho Hyoka(Clinical Evaluation)

Material

Material

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] World Medical Association    
1976 4 1 163 THE WORLD MEDICAL ASSOCIATION, INC. DRAFT DECLARATION OF HELSINKI Recommendaions guiding medical doctors in biomedical research 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 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 Ministry of Health and Welfare    
1990 18 1 159 Japanese Good Clinical Practice Ministry of Health and Welfare    
1990 18 1 169 Manual of Japanese Good Clinical Practice Ministry of Health and Welfare    
1990 18 1 195 The Implication and the Importance of Post-marketing Surveillance in Drug Evaluation Ministry of Health and Welfare    
1990 18 1 197 Method of the Investigation of the Results of Clinical Experience with Drugs 1987 Ministry of Health and Welfare    
1990 18 1 205 Method of the Investigation of the Results of Clinical Experience with Drugs 1988 Ministry of Health and Welfare    
1990 18 1 217 Method of the Investigation of the Results of Clinical Experience with Drugs 1989 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 HHSCFDA 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   ICHEGCP 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 Ministry of Health and Welfare    
1999 27 1 159 Statistical Principles for Clinical Trials [Japanese][English] 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 23 303 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 23 367 Relation between clinical trial's process and compliance review Editorial Committee    
2002 29 23 368 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 23 397 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  
2005 32 23 513 From translational research to critical path research Murayama T    
2005 32 23 517 InnovationEStagnation@|Challenge and opportunity on the critical path to new medical products| U.S. Department of Health and
Human Services,
Food and Drug Administration
Nishikawa A, Asahara M,
Murayama T, et al.
 
2005 32 23 543 FDA Guidance for Industry "Pharmacogenomics Data Submission" and its collaterals |A Japanese translation   Azuma J, Quintiles
Transnational Japan KK
 
2005 32 23 619 Notification on the Pharmacogenomic Data Submissions Ministry of Health,
Labor and Welfare
   
2005 32 23 623 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells.   Yonemoto S  
2005 32 23 633 New drugs for neglected diseases : From pipeline to patients Bernard Pecoul Hirabayashi F  
2005 32 23 639 Is this clinical trial fully registered ? : A Statement from the International Committee of Medical Journal Editors De Angelis C, Drazen JM,
Frizelle FA, et al.
Saio T, Mitsuishi T,
Fukushima M
 
2005 32 23 643 Medical journals are an extension of the marketing arm of pharmaceutical companies Richard Smith Saio T, Mitsuishi T,
Fukushima M
 
2005 33 1 259 From philosophical psychopathology to positivistic psychometrics Saio T    
2005 33 1 261 The Dictionary of Disorder : how one man revolutionized psychiatry Spiegel A Saio T  
2006 33 2 421 Guidance on Central IRB by FDA : Explanatory overview Kurihara C    
2006 33 2 425 Guidance for industry@@Using a centralized IRB review process in multicenter clinical trials Food and Drug Administration Kurihara C, Saio T  
2006 33 3 583 Guidance for Industry, Investigators, and Reviewers@@Exploratory IND Studies U.S. Department of Health and
Human Services,
Food and Drug Administration,
Center for Drug Evaluation and
Research (CDER)
Nishikawa A, Murayama T,
Kasai Y, et al.
 
2006 33 3 600 Exploratory IND Studies : The Perspective from Academia Murayama T    
2006 33 3 603 Guidance for Industry@@INDs |Approaches to Complying with CGMP During Phase 1 U.S. Department of Health and
Human Services,
Food and Drug Administration,
Center for Drug Evaluation and
Research (CDER)
Ezoe S, Murayama T,
Nishikawa A, et al.
 
2006 33 3 625 CGMP regulation for translational research Maekawa T    
2007 34 1 123 Obstacles to Critical Path Research in Japan Murayama T    
2007 34 1 127 InnovationEStagnation@|Critical Path Opportunities Report| U.S. Department of Health and
Human Services,
Food and Drug Administration
Nishikawa A, Murayama T  
2007 34 1 155 InnovationEStagnation@|Critical Path Opportunities List| U.S. Department of Health and
Human Services,
Food and Drug Administration
Murayama T, Yokode M  
2007 34 1 179 The JSQA Guideline for GCP Auditing JSQA, GCP Division,
Special Project
   
2007 34 2 345 Translation of EMEA/CHMP/96268/2005/Guideline on Risk Management Systems for Medicinal Products for Human Barata K, Furukawa A,
Ishida K, et al.
   
2007 34 2 347 Guideline on Risk Management Systems for Medicinal Products for Human Use Committee for Medicinal Products
for Human Use (CHMP)
Saio T, Kurihara C, Pharmacovigilance Working Group  
2007 35 1 91 Guidance for Industry@@Computerized Systems Used in Clinical Investigations U.S. Department of Health and
Human Services, Food and Drug
Administration (FDA),
Office of the Commissioner (OC)
Nishikawa A, Yamamoto K,
Fukushima M
 
2007 35 1 104 Guidance for Industry@@Computerized Systems Used in Clinical Investigations Yamamoto K, Fukushima M    
2007 35 1 107 Guidance for Industry@@Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics U.S. Department of Health and
Human Services, Food and Drug
Administration, Center for Drug
Evaluation andResearch (CDER),
Center for Biologics Evaluation
and Research (CBER)
Nishikawa A, Murayama T,
Kojima S, et al.
 
2007 35 1 128 Selection of optimal endpoints for cancer clinical trials Teramukai S, Fukushima M    
2007 35 1 131 Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products European Medicines Agency
(EMEA), Committee for Medicinal
Products for Human Use (CHMP)
Pharmacovigilance Working Group, Kobayashi K, et al.  
2007 35 1 145 On the EMEA Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products |The impact of the TGN1412 issue Matsumoto K, Unno T,
Kobayashi K, et al.
   
2009 36 3 785 Explanatory review of the FDA guidance on adverse event reporting to IRBs Kurihara C    
2009 36 3 787 Guidance for clinical investigators, sponsors, and IRBs@@Adverse event reporting to IRBs@|Improving human subject protection U.S. Department of Health and
Human Services,Food and Drug
Administration (FDA), Office of the
Commissioner (OC), et al.
Kurihara C  
2012 39 3 563 Global approach to accelerating medical research Kush RD    
2017 45 1 21 Proposals on gClinical Research Implementation Standardh stipulated in Article 3 and other issues of the Draft Clinical Research Act submitted to the 190th Diet (Ordinary Session) Pharmaceutical and Medical Device Regulatory Science Society of Japan    

up date 2017/04/25

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