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Stakeholders' recommendations for revising Good Clinical Practice.

Publication ,  Journal Article
Corneli, A; Forrest, A; Swezey, T; Lin, L; Tenaerts, P
Published in: Contemp Clin Trials Commun
June 2021

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.

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Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

June 2021

Volume

22

Start / End Page

100776

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences
 

Citation

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Corneli, A., Forrest, A., Swezey, T., Lin, L., & Tenaerts, P. (2021). Stakeholders' recommendations for revising Good Clinical Practice. Contemp Clin Trials Commun, 22, 100776. https://doi.org/10.1016/j.conctc.2021.100776
Corneli, Amy, Annemarie Forrest, Teresa Swezey, Li Lin, and Pamela Tenaerts. “Stakeholders' recommendations for revising Good Clinical Practice.Contemp Clin Trials Commun 22 (June 2021): 100776. https://doi.org/10.1016/j.conctc.2021.100776.
Corneli A, Forrest A, Swezey T, Lin L, Tenaerts P. Stakeholders' recommendations for revising Good Clinical Practice. Contemp Clin Trials Commun. 2021 Jun;22:100776.
Corneli, Amy, et al. “Stakeholders' recommendations for revising Good Clinical Practice.Contemp Clin Trials Commun, vol. 22, June 2021, p. 100776. Pubmed, doi:10.1016/j.conctc.2021.100776.
Corneli A, Forrest A, Swezey T, Lin L, Tenaerts P. Stakeholders' recommendations for revising Good Clinical Practice. Contemp Clin Trials Commun. 2021 Jun;22:100776.
Journal cover image

Published In

Contemp Clin Trials Commun

DOI

EISSN

2451-8654

Publication Date

June 2021

Volume

22

Start / End Page

100776

Location

Netherlands

Related Subject Headings

  • 32 Biomedical and clinical sciences