Good clinical practice
Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, that 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.[1]
GCP follows the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study. 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 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 clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.
ICH GCP overview
- Guidelines for the investigator
- Guidelines for the trial sponsor (industrial, academic)
- Guidelines for the clinical trial protocol and protocol amendments
- Guidelines for the Investigator's brochure
Criticism
GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas:[2]
- 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 cites these criticisms and notes that the GCP rules "aren't terrible... [they are] more focused on procedures, while Helsinki clearly articulates moral principles".[3]
See also
- Data monitoring committees
- Directive 2001/20/EC (European Union)
- Drug development
- EudraVigilance
- European Forum for Good Clinical Practice (EFGCP)
- European Medicines Agency (EMEA)
- GxP
- Human experimentation in the United States
- Institutional review board
- Inverse benefit law
- Japan Ministry of Health
- Medical ethics
- Pharmacovigilance
- Pharmaceutical company
References
- ↑ Examples of clinical practice guidelines using 'good clinical practice' as lowest grade of recommendation
- ↑ doi:10.1016/S0140-6736(08)61936-4, retrieved at http://www.swecrin.se/filer/Lancet%2013-14.pdf on 10 Aug 2014
- ↑ Lua error in package.lua at line 80: module 'strict' not found.
External links
- ICH Topic E 6 (R1) Guideline for Good Clinical Practice
- Good Clinical Practice (from U.S. Food and Drug Administration)
- Some Relevant UK Statutory Instruments
