ICH E6(R3) good clinical practice workshop with Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties

• Date:
  Wednesday, 03 June 2020
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

The aim of this workshop was to gather the views of European patients, healthcare professionals and clinical researchers on clinical trials and applying GCP, and their experiences related to these topics. This was in preparation for the revision of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 good clinical practice (GCP) guideline.

ICH decided to revise this guideline to ensure that it will be able address the increasing diversity of clinical-trial designs and data sources, and the different contexts in which clinical trials can be conducted.  The revision also aims to highlight the fact that GCP principles can be satisfied in a variety of ways.

ICH has committed itself to engaging stakeholders in the revision process from the outset, in particular patient representatives and academic clinical researchers. This aims to ensure that the final guideline will meet the needs of those conducting or participating in clinical trials.

EMA is coordinating the stakeholder engagement process on behalf of ICH in Europe. 

For more information on the revision of this guideline, see:

• ICH: Reflection paper on renovation of good clinical practice
• ICH: E6(R3) EWG concept paper, business plan and work plan
• ICH: Summary of the E6(3) stakeholder engagement approach

Documents

Meeting report - ICH E6(R3) Good Clinical Practice workshop with PCWP and HCPWP on 3 June 2020

Reference Number: EMA/309402/2020

Agenda - ICH E6(R3) Good Clinical Practice workshop with PCWP and HCPWP on 3 June 2020

Reference Number: EMA/126621/2020

Presentation - 1.1 Introduction to the ICH guideline development process (L. Lindstrom, M. Bonelli, E. Szepessy)

Presentation - 1.2 Introduction to ICH E6(R3) and stakeholder engagement plan (L. Bregnhøj, F. Sweeney)

Presentation - 1.3 ICH E6 findings from Clinical Trials Transformation Initiative (CTTI) (P. Tenaerts)

Presentation - 2.1 ICH E6 R3 Expert Working Group Perspectives (R. Stanbrook)

Presentation - 3.1 A flavour of patients’ organisations views on ICH E6 guidelines (F. Houyez)

Presentation - 3.1 Patient perspective on renovation of ICH guideline on GCP in clinical trials (M. Greco)

Presentation - 3.2.1 Good Clinical Practice: patient centered, investigator friendly (M. Dreyling)

Presentation - 3.2.2 ICH E6: Good Clinical Practice stick to the principles (M. Landray)

Presentation - 3.2.3 ICH guideline renovation clinical researchers perspectives: ECRIN (J. Demotes)

Presentation - 3.2.4 ICH GCP Stakeholder workshop: European Organisation for Research and Treatment of Cancer (EORTC) perspective (D. Lacombe)