Cited by 504Ethics in Clinical ResearchBiomedical Ethics and RegulationStatistical Methods in Clinical Trials

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THE INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICE GUIDELINE

Dixon, James R·1999·Quality Assurance

DOI 10.1080/105294199277860

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Abstract

The purposes of the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline are to protect the rights of human subjects participating in clinical trials and to ensure the scientific validity and credibility of the data collected in human clinical studies. The guiding principle in the guideline is that the rights, safety, and well-being of the trial subject are the most important considerations and should prevail over the interests of science and society. The guideline will have an important and beneficial impact on the clinical trials conducted in the three participating regions (the United States, Europe, and Japan) as well as many other regions throughout the world. In the years to come, it should fulfill its intended purpose of providing for a more economical use of human, animal, and material resources and the elimination of unnecessary delays in the global development and availability of new medicines, and at the same time maintaining safeguards on quality, safety, and efficacy and regulatory obligations to protect public health.

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Additional file 1 of Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
Cold, I. M., Feinberg, J. B., Brandes, A., Davidsen, U., Dixen, U., Dominguez, H., Gang, U. J. O., Gluud, C., Hadad, R., Kristensen, K. E., et al. (2023) · Figshare · doi:10.6084/m9.figshare.22624924
Additional file 2 of Plasma neurofilament light, glial fibrillary acid protein, and phosphorylated tau 181 as biomarkers for neuropsychiatric symptoms and related clinical disease progression
Rabl, M., Zullo, L., Lewczuk, P., Kornhuber, J., Karikari, T. K., Blennow, K., Zetterberg, H., Bavato, F., Quednow, B. B., Seifritz, E., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26378115
Additional file 1 of Experience and measurement of fatigue in adults with Crohn’s disease: results from qualitative interviews and a longitudinal 2-week daily diary pilot study
Regueiro, M., Delbecque, L., Hunter, T., Stassek, L., Harding, G., & Lewis, J. (2024) · Figshare · doi:10.6084/m9.figshare.26605384
Additional file 2 of Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial
Cold, I. M., Feinberg, J. B., Brandes, A., Davidsen, U., Dixen, U., Dominguez, H., Gang, U. J. O., Gluud, C., Hadad, R., Kristensen, K. E., et al. (2023) · Figshare · doi:10.6084/m9.figshare.22624927
Additional file 1 of Plasma neurofilament light, glial fibrillary acid protein, and phosphorylated tau 181 as biomarkers for neuropsychiatric symptoms and related clinical disease progression
Rabl, M., Zullo, L., Lewczuk, P., Kornhuber, J., Karikari, T. K., Blennow, K., Zetterberg, H., Bavato, F., Quednow, B. B., Seifritz, E., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26377975
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Authors: Dixon, J. R.
Affiliations: Triangle Pharmaceuticals, Inc. (United States) (US)
Corresponding author: Dixon, James R
Venue: Quality Assurance
Publisher: Informa UK Limited
Published: 1999-02
Volume: 6
Issue: 2
Pages: 65-74
ISSN: 1052-9411 (ISSN-L)
1521-0677
DOI: 10.1080/105294199277860
OpenAlex: W1981066923
Cited by: 504
References: 0
Citations by year: 2026: 30 · 2025: 62 · 2024: 63 · 2023: 52 · 2022: 51 · 2021: 53 · 2020: 31 · 2019: 20 · 2018: 19 · 2017: 18 · 2016: 17 · 2015: 20 · 2014: 8 · 2013: 6 · 2012: 7
FWCI: 3.16
Type: journal article
Language: en
Open access: closed
Locations: Quality Assurance (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: good clinical practice, clinical trial ethics, research participant protection, regulatory harmonization, drug development
MeSH terms: Clinical Trials as Topic, Europe, Forms and Records Control, Humans, Human Experimentation, Informed Consent, International Cooperation, Japan, Organizational Objectives, Professional Staff Committees, Quality Control, United States, Investigational New Drug Application, Guidelines as Topic

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