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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Background
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Method
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Method
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“This analysis is in accordance with the ethical approval of theMedical University of Graz and in full compliance with the Austrian Medicinal Products Act and in accordance with the International Conference on Harmonization Good Clinical Practice guideline (27).”
Result
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Söderström, C. M., Medici, R. B., Assadzadeh, S., et al. (2018) · European Journal of Anaesthesiology · doi:10.1097/eja.0000000000000833 · Cited by 18
Conversion due to vascular injury during video-assisted thoracic surgery lobectomy: A multicentre retrospective analysis from the Italian video-assisted thoracic surgery group registry
Bertolaccini, L., Davoli, F., Pardolesi, A., et al. (2019) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2018.12.023 · Cited by 18
“The data were anonymously achieved according to the International Conference on Harmonization Guidelines for Good Clinical Practice [14].”
Method
Obsessive–compulsive disorder (OCD) is associated with increased engagement of frontal brain regions across multiple event-related potentials
Perera, M. P. N., Mallawaarachchi, S., Bailey, N. W., Murphy, O. W., & Fitzgerald, P. B. (2023) · Psychological Medicine · doi:10.1017/s0033291723000843 · Cited by 18
“The trial received ethics approval from the Monash Health Human Research Ethics Committee and was conducted under the Good Clinical Practice guidelines (Dixon, 1999).”
Method
Efficacy and Safety of Once‐Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2–5 Years With Mild‐to‐Moderate Atopic Dermatitis ( INTEGUMENT ‐ PED ): A Phase 3 Randomized Controlled Trial
Eichenfield, L. F., Serrao, R. T., Prajapati, V. H., Browning, J. C., Swanson, L., Funk, T., González, M. E., Hebert, A. A., Lee, M. S., Boguniewicz, M., et al. (2025) · Pediatric Dermatology · doi:10.1111/pde.15840 · Cited by 17
Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body
Gooderham, M., Alonso‐Llamazares, J., Bagel, J., Bhatia, N. D., Bukhalo, M., DuBois, J. C., Ferris, L. K., Green, L., Kircik, L., Lockshin, B., et al. (2025) · JAMA Dermatology · doi:10.1001/jamadermatol.2025.1136 · Cited by 18
Contributory factors to the evolution of the concept and practice of informed consent in clinical research: A narrative review
O'Sullivan, L., Crowley, R., McAuliffe, E., & Doran, P. (2020) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2020.100634 · Cited by 15
“While mainly aimed at the investigational medicinal product trial, it is widely acknowledged that these standards should be applied to all clinical research [46,47].”
Background
Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial
Dichter, M., Berg, A., Hylla, J., Eggers, D., Wilfling, D., Möhler, R., Haastert, B., Meyer, G., Halek, M., & Köpke, S. (2021) · BMC Geriatrics · doi:10.1186/s12877-020-01997-8 · Cited by 13
“The statistical analysis will follow GCP [61] standards and will be conducted by the blinded biostatistician (BH) after the end of follow-up (T2).”
MethodInfluential
Efficacy and safety of belantamab-mafodotin in triple-refractory multiple myeloma patients: A multicentric real-life experience
Iula, R., Novellis, D. D., Trastulli, F., Pepa, R. D., Fontana, R., Carobene, A., Perna, M. D., d’Ambrosio, A., Romano, M., Leone, A., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.1026251 · Cited by 17
“Median PFS, months (range) 1-year PFS Median OS, months (range) 1-year OS Median DOR, months (range) 1-year DOR 3 (0-23) 32% 8 (0-23) 34% 5 (0-23) 41% 11 (1-23) 43% N.”
MethodInfluential
Does Insert Type Affect Clinical and Functional Outcome in Total Knee Arthroplasty? A Randomised Controlled Clinical Trial With 5-Year Follow-Up
Fransen, B. L., Hoozemans, M. J. M., Keijser, L. C. M., Lent, M. R.-V., Verheyen, C. C. P. M., & Burger, B. J. (2015) · The Journal of Arthroplasty · doi:10.1016/j.arth.2015.05.018 · Cited by 17
“guidelines on Good Clinical Practice of the International Conference on Harmonisation [18], and the Declaration of Helsinki [19].”
Background
Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI
Arribas, J. R., DeJesus, E., van Lunzen, J., et al. (2017) · HIV Clinical Trials · doi:10.1080/15284336.2017.1330440 · Cited by 17
Switching to the single-tablet regimen of elvitegravir, cobicistat, emtricitabine, and tenofovir DF from non-nucleoside reverse transcriptase inhibitor plus coformulated emtricitabine and tenofovir DF regimens: Week 96 results of STRATEGY-NNRTI
Pozniak, A. L., Flamm, J., Antinori, A., et al. (2017) · HIV Clinical Trials · doi:10.1080/15284336.2017.1338844 · Cited by 17
Prophylactic treatment of bleeding episodes in children <12 years with moderate to severe hereditary factor X deficiency ( FXD ): Efficacy and safety of a high‐purity plasma‐derived factor X (pd FX ) concentrate
Liesner, R. J., Akanezi, C., Norton, M., et al. (2018) · Haemophilia · doi:10.1111/hae.13500 · Cited by 17
Semiquantitative assessed proteinuria and risk of heart failure: analysis of a nationwide epidemiological database
Fukui, A., Kaneko, H., Okada, A., Yano, Y., Itoh, H., Matsuoka, S., Morita, K., Kiriyama, H., Kamon, T., Fujiu, K., et al. (2021) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfab248 · Cited by 16
Formulation and development of Serratiopeptidase enteric coated tablets and analytical method validation by UV Spectroscopy
Panthi, V. K., Jha, S. K., Chaubey, R., et al. (2021) · International Journal of Analytical Chemistry · doi:10.1155/2021/9749474 · Cited by 17
Sex Difference in the Association between Lipid Profile and Incident Cardiovascular Disease among Young Adults
Kamon, T., Kaneko, H., Itoh, H., Okada, A., Matsuoka, S., Kiriyama, H., Fujiu, K., Morita, K., Michihata, N., Jo, T., et al. (2022) · Journal of Atherosclerosis and Thrombosis · doi:10.5551/jat.63166 · Cited by 18
Clinical Bioavailability of the Novel BACE1 Inhibitor Lanabecestat (AZD3293): Assessment of Tablet Formulations Versus an Oral Solution and the Impact of Gastric pH on Pharmacokinetics
Ye, N., Monk, S. A., Daga, P., Bender, D. M., Rosen, L. B., Mullen, J., Minkwitz, M. C., & Kugler, A. R. (2018) · Clinical Pharmacology in Drug Development · doi:10.1002/cpdd.422 · Cited by 17
Impact of pre‐existing hypertension and control status before atrial fibrillation onset on cardiovascular prognosis in patients with non‐valvular atrial fibrillation: A real‐world database analysis in Japan
Kario, K., Abe, T., & Kanegae, H. (2019) · Journal of Clinical Hypertension · doi:10.1111/jch.13755 · Cited by 15
Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in HIV-infected people in Kenya (YEFE): a randomised, double-blind, non-inferiority substudy of a phase 4 trial
Kimathi, D., Juan-Giner, A., Orindi, B., et al. (2023) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(23)00114-7 · Cited by 16
Pharmacokinetics, pharmacodynamics, and safety of fesomersen, a novel antisense inhibitor of factor XI, in healthy Chinese, Japanese, and Caucasian volunteers
Liu, T., Hashizume, K., Krieg, E., et al. (2024) · Clinical and Translational Science · doi:10.1111/cts.13784 · Cited by 16
Serum magnesium concentrations in patients receiving sodium picosulfate and magnesium citrate bowel preparation: an assessment of renal function and electrocardiographic conduction
Bertiger, G., Jones, E. S., Dahdal, D. N., Marshall, D. C., & Joseph, R. E. (2015) · Clinical and Experimental Gastroenterology · doi:10.2147/ceg.s79216 · Cited by 16
Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate
Kluge, M., Hegerl, U., Sander, C., Dietzel, J., Mergl, R., Bitter, I., Demyttenaere, K., Gusmão, R. M., González-Pinto, A. M., Pérez, V., et al. (2013) · BMC Psychiatry · doi:10.1186/1471-244x-13-71 · Cited by 16
Acute hepatitis A, B and C but not D is still prevalent in Mongolia: a time trend analysis
Baatarkhuu, O., Lee, H. W., George, J., et al. (2017) · Clinical and Molecular Hepatology · doi:10.3350/cmh.2016.0055 · Cited by 16
“The study was conducted in accordance with the international ethical guidelines of the International Conference on Harmonization Guidelines for Good Clinical Practice.10”
Method
Risk factors of pre‐hypertension and hypertension among non‐pregnant women of reproductive age in northeastern Tanzania: a community based cross‐sectional study
Msemo, O. A., Schmiegelow, C., Nielsen, B. B., Kousholt, H., Grunnet, L. G., Christensen, D. L., Lusingu, J., Møller, S. L., Kavishe, R. A., Minja, D. T. R., et al. (2018) · Tropical Medicine & International Health · doi:10.1111/tmi.13149 · Cited by 17
“Written informed consent was obtained from each woman before enrolment into the study in accordance with the Declaration of Helsinki [33].”
Method
Smartphone-based optical palpation: towards elastography of skin for telehealth applications
Sanderson, R. W., Fang, Q., Curatolo, A., Taba, A., DeJong, H. M., Wood, F. M., & Kennedy, B. F. (2021) · Biomedical Optics Express · doi:10.1364/boe.424567 · Cited by 14
“All methods and procedures were performed in accordance with the relevant guidelines and regulations, including following good clinical practices described at the International Conference on Harmonisation [38].”
Method
Clinical features and health-related quality of life in adult patients with mucopolysaccharidosis IVA: the Spanish experience
Quijada‐Fraile, P., Canales, E. A., Martín‐Hernández, E., et al. (2021) · Orphanet Journal of Rare Diseases · doi:10.1186/s13023-021-02074-y · Cited by 16
“In addition, the study was conducted in accordance with the Declaration of Helsinki [28], the International Conference on Harmonisa‐ tion Guideline for Good Clinical Practice [29], and the Spanish regulations.”
Method
The Science of the Placebo
Robinson, A. (2008) · South African Medical Journal · doi:10.7196/samj.2128 · Cited by 16
A Randomized Controlled Trial Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation in the General Population: E3 Trial Design
Hébert-Losier, A., Filion, K. B., Windle, S. B., & Eisenberg, M. J. (2020) · CJC Open · doi:10.1016/j.cjco.2020.03.006 · Cited by 16
“The study conforms to the International Conference on Harmonization, GCP guidelines, and the ethical principles embodied in the Declaration of Helsinki.22,23 The trial results will be published in peer-reviewed scientific journals and made available on clinicaltrials.gov.”
BackgroundInfluential
Acceptance and Commitment Therapy for Muscle Disease (ACTMus): Protocol for a two-arm randomised controlled trial of a brief guided self-help ACT programme for improving quality of life in people with muscle diseases
Rose, M. R., Norton, S., Vari, C., Edwards, V., McCracken, L., Graham, C. D., Radunovic, A., & Chalder, T. (2018) · BMJ Open · doi:10.1136/bmjopen-2018-022083 · Cited by 15
Assessment of Preparedness for Remote Teaching and Learning to Transform Health Professions Education in Sub-Saharan Africa in Response to the COVID-19 Pandemic: Protocol for a Mixed Methods Study With a Case Study Approach
Kagawa, M. N., Chipamaunga, S. R., Prozesky, D. R., et al. (2021) · JMIR Research Protocols · doi:10.2196/28905 · Cited by 15
“Relevant safeguards required in studies involving human participants, as outlined in the Belmont report of 1979 and the International Conference on Harmonization (ICH) of 2002, will be applied as the overarching ethics framework for this study [17,18].”
Background
Blood plasma protein profiles of neuropsychiatric symptoms and related cognitive decline in older people
Rabl, M., Clark, C., Dayon, L., Bowman, G. L., & Popp, J. (2022) · Journal of Neurochemistry · doi:10.1111/jnc.15715 · Cited by 15
“The study was conducted in accordance with applicable laws and regulations, including the International Conference on Harmonization, Guideline for Good Clinical Practice (Dixon, 1998) and the ethical principles from the Declaration of Helsinki (Association WM, 2013).”
Method
The Global Kidney Patient Trials Network and the CAPTIVATE Platform Clinical Trial Design
Kotwal, S. S., Perkovic, V., Jardine, M., Kim, D., Shah, N. A., Lin, E., Coggan, S. E., Billot, L., Vart, P., Wheeler, D. C., et al. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.49998 · Cited by 16
Training with Agency-Inspired Feedback from an Instrumented Glove to Improve Functional Grasp Performance
Liu, M., Wilder, S., Sanford, S., Saleh, S., Harel, N. Y., & Nataraj, R. (2021) · Sensors · doi:10.3390/s21041173 · Cited by 15
“Experimental procedures were explained and executed consistent with guidelines from [22] intended to ensure subject well-being and data credibility, among other good practices for human subject research.”
Method
Rectal cancer response to neoadjuvant chemoradiotherapy evaluated with MRI: Development and validation of a classification algorithm
Rengo, M., Landolfi, F., Picchia, S., et al. (2022) · European Journal of Radiology · doi:10.1016/j.ejrad.2021.110146 · Cited by 15
Relationship of normal-weight central obesity with the risk for heart failure and atrial fibrillation: analysis of a nationwide health check-up and claims database
Ueno, K., Kaneko, H., Kamiya, K., Itoh, H., Okada, A., Suzuki, Y., Matsuoka, S., Fujiu, K., Michihata, N., Jo, T., et al. (2022) · European Heart Journal Open · doi:10.1093/ehjopen/oeac026 · Cited by 16
“All data were compliant with the International Conference on Harmonization guidelines.(22)”
Method
Global issues in drug development for Alzheimer's disease
Doody, R. S., Cole, P. E., Miller, D. S., Siemers, E., Black, R. S., Feldman, H., Schindler, R. J., Graham, S. M., Heath, T., Khachaturian, A. S., et al. (2011) · Alzheimer s & Dementia · doi:10.1016/j.jalz.2011.01.001 · Cited by 15
“Operationalizing good clinical practice (GCP) is also an issue when conducting global clinical trials [25,26].”
Background
Adverse events in a chiropractic spinal manipulative therapy single-blinded, placebo, randomized controlled trial for migraineurs
Chaibi, A., Benth, J. Š., Tuchin, P. J., & Russell, M. B. (2017) · Musculoskeletal Science and Practice · doi:10.1016/j.msksp.2017.03.003 · Cited by 15
“Good clinical practice guidelines and the Declaration of Helsinki were followed (Dixon, 1998; WMA, 2013).”
Method
LC–MS/MS Assay for N 1 -Methylnicotinamide in Humans, an Endogenous Probe for Renal Transporters
Luo, L., Kay, J., Zhang, J., et al. (2018) · Bioanalysis · doi:10.4155/bio-2017-0272 · Cited by 15

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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