Good clinical practice

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In drug development and production, 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 Registration of Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.

Contents

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.

History

ICH first published the GCP guidelines in 1996 under the "E6" category and was last amended in 2016. [2]

ICH GCP overview

Criticism

GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: [6]

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". [7]

See also

References

  1. "ICH Official web site : ICH". www.ich.org. Retrieved 2021-11-24.
  2. "Efficacy Guidelines". International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Archived from the original on 10 February 2022. Retrieved 12 September 2024.
  3. "Clinical trials - Directive 2001/20/EC - European Commission".
  4. Commissioner, Office of the. "Clinical Trials and Human Subject Protection". www.fda.gov. Archived from the original on June 2, 2009. Retrieved 2018-11-01.
  5. "Good Clinical Practice Training | grants.nih.gov". grants.nih.gov. Retrieved 2020-04-03.
  6. 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.
  7. Ben Goldacre (2012). Bad Pharma. London: Fourth Estate. OL   25682902M.