Adaptive clinical trials for new drug applications in Japan

European Neuropsychopharmacology

Volumn 21, Issue 2, 2011, Pages 175-179

  Ando, Yuki ^a   Hirakawa, Akihiro ^a   Uyama, Yoshiaki ^a  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Adaptive design; Interim analysis; New drug application

Indexed keywords

LATANOPROST PLUS TIMOLOL; NEW DRUG;

ADAPTIVE DESIGN; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); DOSE CALCULATION; DRUG EFFICACY; DRUG SAFETY; GLAUCOMA; INTRAOCULAR HYPERTENSION; JAPAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROFESSIONAL STANDARD; PROGRAM DEVELOPMENT; REPRODUCIBILITY; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; STUDY DESIGN; SYSTEMATIC ERROR;

CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DEVICE APPROVAL; DRUG APPROVAL; HUMANS; JAPAN; RESEARCH DESIGN; SAMPLE SIZE;

EID: 78751625153     PISSN: 0924977X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2010.09.002     Document Type: Review

References (9)

1. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design 2007, Committee for Medical Product for Human Use (CHMP), Available at: www.emea.europa.eu/pdfs/human/ewp/245902enadopted.pdf.
2. Gallo P., et al. Executive summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development. J. Biopharm. Stat. 2006, 16:275-283.
3. Gaydos B., et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf. J. 2009, 43:539-556.
4. Ministry of Health, Labour and Welfare (MHLW). Basic principles on global clinical trials. Notification No.0928010, Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, MHLW, September 28, 2007. Available at: http://www.pmda.go.jp/english/service/pdf/notifications/0928010-e.pdf.
5. PMDA, Review report of latanoprost and timolol maleate. November 10, 2009 (in Japanese). Available at: http://www.info.pmda.go.jp/shinyaku/g100102/40007900_22200AMX00232_A100_1.pdf.
6. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E5: Ethnic Factors in the Acceptability of Foreign Clinical Data. Step5, February 1998. Available at: http://www.ich.org/LOB/media/MEDIA481.pdf.
7. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E9: Statistical Principles for Clinical Trials. Step5, February 1998. Available at: http://www.ich.org/LOB/media/MEDIA485.pdf.
8. Guidance for Industry. Adaptive Design Clinical Trials for Drugs and Biologics. Draft Guidance 2010, U.S. Food and Drug Administration (FDA), Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf.
9. Uyama Y., et al. Successful bridging strategy based on ICH E5 guideline for drugs approval in Japan. Clin. Pharmacol. Ther. 2005, 78:102-113.