ICH HARMONISED TRIPARTITE GUIDELINE CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS E10 Current Step 4 version dated 20 July 2000 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

The ICH E11A Guideline reached Step 4 of the ICH process on 21 August 2024. The E11A Guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines.

2001年1月1日 · This document describes the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues. Keywords: Clinical trial design. ICH: E 10: Choice of control group in clinical trials - Step 5.

This guidance is intended to assist applicants in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment. The guidance also discusses related trial design...

2024年12月11日 · ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)

E10 Choice of Control Group in Clinical Trials/试验中对照组的选择; E11 Clinical Trials in Pediatric Population/儿童人群临床研究; E12 Clinical Evaluation by Therapeutic Category/根据治疗类别进行临床评价; E14 Clinical Evaluation of QT/QT临床评价

This document addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence / non-inferiority trials that limits the usefulness of trial design in many circumstances.

2001年5月14日 · The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E10 Choice of Control Group and Related Issues in Clinical Trials." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration o …

The International Conference on Harmonisation (ICH) has developed a guideline entitled “Choice of Control Group in Clinical Trials” (ICH –E10), which was approved in July 2000 for implementation in all ICH regions, i.e. Europe, Japan and USA (1).

10 Years with ICH E10: Choice of Control Groups. 10 Years with ICH E10: Choice of Control Groups Pharm Stat. 2011 Sep-Oct;10(5):407-9. doi: 10.1002/pst.500. Epub 2011 Sep 16. Authors Frank W Rockhold 1 , Gregory G Enas. Affiliation 1 GlaxoSmithKline R&D, Research Triangle Park, NC, USA. Frank. [email protected] ...