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. 2021 Apr 16:22:100776.
doi: 10.1016/j.conctc.2021.100776. eCollection 2021 Jun.

Stakeholders' recommendations for revising Good Clinical Practice

Amy Corneli  1   2   3 , Annemarie Forrest  1 , Teresa Swezey  1   2 , Li Lin  1   2 , Pamela Tenaerts  1
Affiliations

Stakeholders' recommendations for revising Good Clinical Practice

Amy Corneli et al. Contemp Clin Trials Commun. .

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is revising ICH E6 Good Clinical Practice (GCP). The Clinical Trials Transformation Initiative (CTTI) initiated a project to identify and provide ICH with stakeholders' priority areas and suggestions for revising ICH E6 GCP. We conducted a global online survey to identify areas of ICH E6 GCP that are and are not in need of revision. A total of 327 stakeholders completed the survey. Stakeholders represent many research roles and types of organizations, are employed in 39 countries, and conduct research in 153 countries. The ICH E6 GCP principles mentioned most often (range, 25%-29%) in need of revision were implementing systems that assure quality, providing medical care by qualified physicians/dentists, protecting confidentiality and privacy, obtaining informed consent, and documenting and storing information. The Investigator section (n = 244, 75%) and Sponsor section (n = 242, 74%) of ICH E6 GCP were identified as needing the most revision and the Investigator Brochure section (n = 166, 51%) as needing the least revision. The topic most frequently mentioned as needing revision is Monitoring (n = 146; 45%) in the Sponsor section. Although none of the principles or topics in ICH E6 GCP were identified as needing revision by the majority of stakeholders, a meaningful percentage of stakeholders identified areas that they believe need revision. These findings, which represent the views of a wide variety of stakeholders, may be useful to ICH for identifying where specifically to focus their revision efforts. CTTI provided the final report to ICH with the project findings for their consideration.

Keywords: Clinical trials; Ethics; Good clinical practice; ICH E6 GCP; Regulatory; Stakeholders.

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Conflict of interest statement

We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.

Figures

Fig. 1
Fig. 1
Stakeholder recommendations for revising the ICH E6 GCP principles.
Fig. 2
Fig. 2
Stakeholder recommendations for revising the ICH E6 GCP topics by section.
See this image and copyright information in PMC

References

    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated Addendum to ICHE6(r1): Guideline for Good Clinical Practice E6(R2). Step 4 version dated 9 November 2016.
    1. International Council for harmonisation of technical Requirements for pharmaceuticals for human use (ICH) https://ich.org
    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ICH reflection on “GCP renovation”: modernization of ICH E8 and subsequent renovation of ICH E6. 2017. https://admin.ich.org/sites/default/files/2019-04/ICH_Reflection_paper_G...
    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Final concept paper ICH E6(R3): guideline for Good clinical practice. 2019. https://database.ich.org/sites/default/files/E6-R3_FinalConceptPaper_201...
    1. Updated open letter to EMA & ICH in Response to ICH GCP. 26 February 2016. http://moretrials.net/the-problem

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