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Good clinical practice

January 01, 1970

Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented.

GCP guidelines[1] include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.

A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice for international consistency of quality research.

Legal and regulatory status edit

  • European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC).[2] A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.
  • United States: Although ICH GCP guidelines are recommended by the Food and Drug Administration (FDA),[3] they are not statutory in the United States. The National Institutes of Health requires NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice.[4]

ICH GCP overview edit

Criticism edit

GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas:[5]

  • Disclosure of conflict of interest
  • Public disclosure of study design
  • Benefit for populations in which research is conducted
  • Reporting of accurate results and publication of negative findings
  • Access to treatment after research has been conducted
  • Restriction of use of placebo in control group where effective alternative treatment is available

In the book Bad Pharma, Ben Goldacre mentions these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles".[6]

See also edit

References edit

  1. ^ "ICH Official web site : ICH". www.ich.org. Retrieved 2021-11-24.
  2. ^ https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en
  3. ^ Commissioner, Office of the. "Clinical Trials and Human Subject Protection". www.fda.gov. Retrieved 2018-11-01.
  4. ^ "Good Clinical Practice Training | grants.nih.gov". grants.nih.gov. Retrieved 2020-04-03.
  5. ^ Kimmelman, Jonathan; Weijer, Charles; Meslin, Eric M (2009). "Helsinki discords: FDA, ethics, and international drug trials". The Lancet. 373 (9657): 13–14. doi:10.1016/S0140-6736(08)61936-4. PMID 19121708.
  6. ^ Ben Goldacre (2012). Bad Pharma. London: Fourth Estate. OL 25682902M.

External links edit

January 01, 1970
good, clinical, practice, international, quality, standard, which, governments, then, transpose, into, regulations, clinical, trials, involving, human, subjects, follows, international, council, harmonisation, technical, requirements, pharmaceuticals, human, e. Good clinical practice GCP is an international quality standard which governments can then transpose into regulations for clinical trials involving human subjects GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICH and enforces tight guidelines on ethical aspects of clinical research High standards are required in terms of comprehensive documentation for the clinical protocol record keeping training and facilities including computers and software Quality assurance and inspections ensure that these standards are achieved GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented GCP guidelines 1 include protection of human rights for the subjects and volunteers in a clinical trial It also provides assurance of the safety and efficacy of the newly developed compounds GCP guidelines include standards on how clinical trials should be conducted define the roles and responsibilities of institutional review boards clinical research investigators clinical trial sponsors and monitors In the pharmaceutical industry monitors are often called clinical research associates A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH and GCP guidelines in the US and Europe These discussions ultimately led to the development of certain regulations and guidelines which evolved into the code of practice for international consistency of quality research Contents 1 Legal and regulatory status 2 ICH GCP overview 3 Criticism 4 See also 5 References 6 External linksLegal and regulatory status editEuropean Union In the EU Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation Officially Regulation EU No 536 2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use and repealing Directive 2001 20 EC 2 A similar guideline for clinical trials of medical devices is the international standard ISO 14155 which is valid in the European Union as a harmonized standard These standards for clinical trials are sometimes referred to as ICH GCP or ISO GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines United States Although ICH GCP guidelines are recommended by the Food and Drug Administration FDA 3 they are not statutory in the United States The National Institutes of Health requires NIH funded clinical investigators and clinical trial staff who are involved in the design conduct oversight or management of clinical trials to be trained in Good Clinical Practice 4 ICH GCP overview editGlossary Principles of ICH GCP Guidelines for institutional review board IRB independent ethics committee IEC investigator trial sponsor industrial academic clinical trial protocol and protocol amendments investigator s brochure essential documentsCriticism editGCP has been called a less morally authoritative document than the Declaration of Helsinki lacking moral principles and guidance in the following areas 5 Disclosure of conflict of interest Public disclosure of study design Benefit for populations in which research is conducted Reporting of accurate results and publication of negative findings Access to treatment after research has been conducted Restriction of use of placebo in control group where effective alternative treatment is available In the book Bad Pharma Ben Goldacre mentions these criticisms and notes that the GCP rules aren t terrible they are more focused on procedures while Helsinki clearly articulates moral principles 6 See also editData monitoring committees Directive 2001 20 EC European Union Drug development EudraVigilance European Forum for Good Clinical Practice EFGCP European Medicines Agency EMA GxP Human experimentation in the United States Institutional review board Inverse benefit law Medical ethics Pharmacovigilance Pharmaceutical companyReferences edit ICH Official web site ICH www ich org Retrieved 2021 11 24 https health ec europa eu medicinal products clinical trials clinical trials directive 200120ec en Commissioner Office of the Clinical Trials and Human Subject Protection www fda gov Retrieved 2018 11 01 Good Clinical Practice Training grants nih gov grants nih gov Retrieved 2020 04 03 Kimmelman Jonathan Weijer Charles Meslin Eric M 2009 Helsinki discords FDA ethics and international drug trials The Lancet 373 9657 13 14 doi 10 1016 S0140 6736 08 61936 4 PMID 19121708 Ben Goldacre 2012 Bad Pharma London Fourth Estate OL 25682902M External links editICH Topic E 6 R2 Good Clinical Practice from U S Food and Drug Administration Retrieved from https en wikipedia org w index php title Good clinical practice amp oldid 1223944627, wikipedia, wiki, book, books, library,

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