ICH Guidelines for Biostatisticians in Industry

European guidances
- CPMP/EWP/2158/99 Guideline on the Choise of the Non-Inferiority Margin (Adopted by Committee July 2005)
- CPMP/EWP/2158/99 Points to Consider on Non-Inferiority Margin (Released for consultation February 2004)
- CPMP/EWP/482/99 Points to Consider on Switching between Superiority and Non-inferiority (Adopted July 2000)
- CPMP/EWP/2863/99 Points to Consider on Adjustment for baseline Covariates (CPMP adopted May 2003)
- CPMP/EWP/908/99 CPMP Points to Consider on Multiplicity issues in Clinical Trials (CPMP Adopted September 2002)
- CPMP/EWP/1776/99 Points to Consider on Missing Data ( Adopted November 2001)
- CPMP/2330/99 Points to Consider on Application with 1.) Meta-analyses and 2.) One Pivotal study (adopted by CPMP May 2001)
- CPMP/EWP/QWP/1401/98 Note For Guidance on the Investigation of Bioavailability and Bioequivalence (Adopted July 2001)
- CHMP/EWP/2459/02 Reflection Paper on Methodological Issues in Confirmatory Clinical Trials with Flexible design and Analysis Plan (adoption by CHMP 18 October 2007) New!
- CHMP/EWP/83561/05 Guideline on Clinical Trials in Small Populations (Adopted by CHMP July 2006) Q&A
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US guidances　Some PDF files below might require to embed WP???? fonts. If you find font related message when invoking Adobe Acrobat, please inform. They will be fixed soon.
- Statistical Approaches to Establishing Bioequivalence (Issued 2/2001, Posted 2/1/2001) 3616fnl.pdf
  - In Vivo Bioequivalence Studies Based on Population and Individual Bioequivalence Studies (Issued 12/10/1997, Posted 12/10/1997) 1716dft.pdf
  - Bioequivalence Studies Data and Detailed Statistical Methodology (Posted 3/2/1998) http://www.fda.gov/cder/bioequivdata/index.htm
- In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling 2635fnl.pdf (Issued 11/24/1999, Posted 11/24/1999)
- Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling 3625fnl.pdf (Posted 5/30/2003)
- Pharmacokinetics in Patients with Impaired Renal Function 1449fnl.pdf (Issued 5/14/1998, Posted 5/14/1998)
- Population Pharmacokinetics 1852fnl.pdf (Issued 2/1999, Posted 2/10/1999)
- Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products 1397fnl.pdf (Issued 5/14/1998, Posted 5/14/1998)
- Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs old036fnl.pdf (Issued 7/22/1993, Posted 3/2/1998)
- Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications [Word: 5341fnl.doc] or [PDF: 5341fnl.pdf] (Posted 5/5/2003)

Electronic Clinical Trial New!

PhRMA "Electronic Clinical Data Capture Position Paper Revision 1" (2005/05/01)
http://www.eclinicalforum.com/frameknowledge.htm
Reports, Presentations, Articles and Publicationsにあります
PhRMA "The Future Vision of Electronic Health Records as eSource for Clinical Research" Version 1.0 (2006/9/14)
http://www.eclinicalforum.com/content/Knowledge/Articles/Future%20EHR-CR%20Environment%20Version%201.pdf
EMEA "Reflection Paper on Expectations for Electronic Source Documentsused in Clinical Trials" (Draft 2007/10/17)
http://www.emea.europa.eu/Inspections/docs/50562007en.pdf
CDISC "eSourceData Interchange initiative" (v1.0 2006/11/20)
http://www.cdisc.org/eSDI/eSDI.pdf
FDA "Guidance for Industry: Computerized Systems Used in Clinical Investigations" (2007/05)
http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf
FDA "Guidance for Industry on Part 11, Electronic Records; ElectronicSignatures--Scope and Application" (2003/08)
http://www.fda.gov/ohrms/dockets/98fr/5667fnl.pdf
FDA "Guidance for Industry and FDA Staff: General Principles of Software Validation" (2002/01/11)
http://www.fda.gov/cdrh/comp/guidance/938.pdf
「医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について」（薬食発第0401022号2005/04/01）
パブリックコメント結果

医療情報システムの安全管理に関するガイドライン第3版(2008/03）
http://www.mhlw.go.jp/shingi/2008/03/dl/s0301-2f.pdf
　
EU "GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP”ENVIRONMENTS" (PIC/S Guidance 2007/09/25)
http://www.picscheme.org/publis/recommandations/PI%20011-3%20Recommendation%20on%20Computerised%20Systems.pdf
SCDM "Good Clinical Data Management Practices" (GCDMP) (2007/05)
https://www.scdm.org/gcdmp/
Needs membership to download
製薬協自主ガイダンスおよび説明会資料
http://www.jpma.or.jp/about/basis/guide/clinical.html

Anticancer drug development related links New!

NCI

Japan

抗悪性腫瘍薬の臨床評価方法に関するガイドライン改訂版(2005/11) 通知本文
抗悪性腫瘍薬の臨床評価方法に関するガイドライン Q&A(2006/3)
パブリックコメント結果（ZIP)

FDA

Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics(2007/05)
Japanese Translation : http://jsmo.umin.jp/oshirase/20071005.html
Guidance for Industry Cancer Drug and Biological Products - Clinical Data in Marketing Applications (2001/11)
Guidance for Industry FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products (1998/12)

EMEA

Guideline on the Evaluation of Anticancer Medicinal Products in Man (CHMP/EWP/205/95 REV. 3) (2005/12)
Guideline on the Evaluation of Anticancer Medicinal Products in Man - Methodological Considerations for Using Progression-Free Survival (PFS) as Primary endpoints in confirmatory trials for registration Human (2008/01)
Others: See "Antineoplastic and immunomodulating agents " of Scientific Guidelines for Human Medicinal Products http://www.emea.europa.eu/htms/human/humanguidelines/efficacy.htm

Organizations

Download (Document Tools)

Japanese Statistics Guideline (4 March 1992)
- PDF Japanese English

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Original files of ICH guidelines were obtained from Regulatory Authority sites and are edited.
Source guidance documents are provided by Regulatory Authority mainly as PDF format..
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This page is maintained by Akihiro Kobayashi. If there are mismatches with original ICH guidelines, they due to the editor's mistake. If you find any mistakes, please notify by email.