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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Fasting plasma glucose and subsequent cardiovascular disease among young adults: Analysis of a nationwide epidemiological database
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IFNL3 polymorphisms predict response to therapy in chronic hepatitis C genotype 2/3 infection
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Additional evidence for a therapeutic effect of dextromethorphan/quinidine on bulbar motor function in patients with amyotrophic lateral sclerosis: A quantitative speech analysis
Green, J. R., Allison, K. M., Cordella, C., Richburg, B. D., Pattee, G. L., Berry, J. D., Macklin, E. A., Pioro, E. P., & Smith, R. A. (2018) · British Journal of Clinical Pharmacology · doi:10.1111/bcp.13745 · Cited by 39
Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation—an exception from consent trial terminated early
Paradis, N. A., Young, G. S., Lemeshow, S. A., Brewer, J. E., & Halperin, H. R. (2010) · The American Journal of Emergency Medicine · doi:10.1016/j.ajem.2010.02.002 · Cited by 39
“In evaluating the trial, we compared its design and execution to recognized Good Clinical Practice as described by the International Conference on Harmonization [8].”
Method
CD19+ B-Cells, a New Biomarker of Mortality in Hemodialysis Patients
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“All procedures were performed according to good clinical practice guidelines and all patients gave their written informed consent for study participation (38).”
Method
Participants’ responsibilities in clinical research
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Prevalence and risk factors of preconception anemia: A community based cross sectional study of rural women of reproductive age in northeastern Tanzania
Msemo, O. A., Bygbjerg, I. C., Møller, S. L., Nielsen, B. B., Ødum, L., Perslev, K., Lusingu, J., Kavishe, R. A., Minja, D. T. R., & Schmiegelow, C. (2018) · PLoS ONE · doi:10.1371/journal.pone.0208413 · Cited by 37
Matched-pair comparison of three different approaches for thymectomy in myasthenia gravis
Sobel, H. K., G�hring, S., Einh�upl, K. M., et al. (2003) · Surgical Endoscopy · doi:10.1007/s00464-002-9162-6 · Cited by 37
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“LOD and LOQ were defined as the signal-to-noise ratio equal to 3 and 10 respectively, according 215 to the International Conference on Harmonization (ICH) Guideline (Dixon, 1999).”
Method
The 5-year Tysabri global observational program in safety (TYGRIS) study confirms the long-term safety profile of natalizumab treatment in multiple sclerosis
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Method
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“The International Conference on Harmonization Good Clinical Practice guideline.”
Method
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Clinical evidence for silver diamine fluoride to reduce dentine hypersensitivity: A systematic review
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Postprandial C ‐peptide to glucose ratio as a predictor of β‐cell function and its usefulness for staged management of type 2 diabetes
Lee, E. Y., Hwang, S., Lee, S. H., Lee, Y., Choi, A. R., Lee, Y., Lee, B., Kang, E. S., Ahn, C. W., Soo, B., et al. (2014) · Journal of Diabetes Investigation · doi:10.1111/jdi.12187 · Cited by 32
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Quality of Life in High Myopia
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Non-transferrin-bound iron is associated with biomarkers of oxidative stress, inflammation and endothelial dysfunction in type 2 diabetes
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Metabolic syndrome and cardiovascular disease in cancer survivors
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Experience of a new high‐purity factor X concentrate in subjects with hereditary factor X deficiency undergoing surgery
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“The study was compliant with International Conference on Harmonization Good Clinical Practice guidelines for conducting, recording and reporting clinical studies [39].”
Method
Possible association between eating behaviors and cardiovascular disease in the general population: Analysis of a nationwide epidemiological database
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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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