Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2)
Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision t...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-10-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422001004 |
| _version_ | 1798033946630422528 |
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| author | Carrie Dombeck Teresa Swezey Annemarie Forrest Pamela Tenaerts Amy Corneli |
| author_facet | Carrie Dombeck Teresa Swezey Annemarie Forrest Pamela Tenaerts Amy Corneli |
| author_sort | Carrie Dombeck |
| collection | DOAJ |
| description | Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision to E6(R2) is currently underway, aiming to adapt the guidance to the current regulatory environment. The Clinical Trials Transformation Initiative (CTTI) interviewed stakeholders, gathering their experiences implementing ICH E6 GCP and suggestions for revising the guidance. Methods: We conducted a qualitative descriptive study using in-depth interviews. Participants were purposefully selected to ensure diversity in geography, research role, and type of institution. Participants reflected on their aspirations for the ICH E6 GCP revision and described sections of the guidance that they found most and least helpful. Narratives were analyzed using applied thematic analysis. Results: Many participants found ICH E6 GCP generally clear and helpful. They appreciated that the guidance is globally accepted and serves as a common standard for research worldwide. Participants also noted opportunities for improvement, suggesting that the revised guidance should incorporate flexibility, simplify requirements, and accommodate advances in research conduct. They highlighted areas where language should be updated and concepts clarified and expressed a desire for transparency and inclusiveness in the revision process. Conclusion: Our findings show that many participants view the ICH E6(R2) guidance as helpful overall, although substantial room for improvement remains. We have provided the full report of these findings to ICH in hopes that it will be useful as the E6 GCP guideline is revised. |
| first_indexed | 2024-04-11T20:37:29Z |
| format | Article |
| id | doaj.art-f68bdcdf722f4905b2c866501ef27be7 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-11T20:37:29Z |
| publishDate | 2022-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-f68bdcdf722f4905b2c866501ef27be72022-12-22T04:04:20ZengElsevierContemporary Clinical Trials Communications2451-86542022-10-0129100983Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2)Carrie Dombeck0Teresa Swezey1Annemarie Forrest2Pamela Tenaerts3Amy Corneli4Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USAClinical Trials Transformation Initiative, Duke University, Durham, NC, USA; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USAClinical Trials Transformation Initiative, Duke University, Durham, NC, USAClinical Trials Transformation Initiative, Duke University, Durham, NC, USAClinical Trials Transformation Initiative, Duke University, Durham, NC, USA; Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Corresponding author. Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St, Durham, NC 27701, USA.Background: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has published the ICH E6(R2) Good Clinical Practice (GCP) guideline, which provides standards for the design, conduct, documentation, and reporting of clinical trials. Revision to E6(R2) is currently underway, aiming to adapt the guidance to the current regulatory environment. The Clinical Trials Transformation Initiative (CTTI) interviewed stakeholders, gathering their experiences implementing ICH E6 GCP and suggestions for revising the guidance. Methods: We conducted a qualitative descriptive study using in-depth interviews. Participants were purposefully selected to ensure diversity in geography, research role, and type of institution. Participants reflected on their aspirations for the ICH E6 GCP revision and described sections of the guidance that they found most and least helpful. Narratives were analyzed using applied thematic analysis. Results: Many participants found ICH E6 GCP generally clear and helpful. They appreciated that the guidance is globally accepted and serves as a common standard for research worldwide. Participants also noted opportunities for improvement, suggesting that the revised guidance should incorporate flexibility, simplify requirements, and accommodate advances in research conduct. They highlighted areas where language should be updated and concepts clarified and expressed a desire for transparency and inclusiveness in the revision process. Conclusion: Our findings show that many participants view the ICH E6(R2) guidance as helpful overall, although substantial room for improvement remains. We have provided the full report of these findings to ICH in hopes that it will be useful as the E6 GCP guideline is revised.http://www.sciencedirect.com/science/article/pii/S2451865422001004Good clinical practiceResearch designClinical trialsICH E6 |
| spellingShingle | Carrie Dombeck Teresa Swezey Annemarie Forrest Pamela Tenaerts Amy Corneli Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) Contemporary Clinical Trials Communications Good clinical practice Research design Clinical trials ICH E6 |
| title | Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) |
| title_full | Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) |
| title_fullStr | Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) |
| title_full_unstemmed | Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) |
| title_short | Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2) |
| title_sort | stakeholders views on the most and least helpful aspects of the ich e6 gcp guideline and their aspirations for the revision of ich e6 r2 |
| topic | Good clinical practice Research design Clinical trials ICH E6 |
| url | http://www.sciencedirect.com/science/article/pii/S2451865422001004 |
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