| 词条 | Good clinical practice |
| 释义 |
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 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 (The International Council for Harmonisation) and GCP guidelines in the US and Europe. Such was the case with the Elixir Sulphanilamide disaster in 1937 or the Thalidomide incident of the 1960s. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice by which all those involved in clinical research now work. This code is known as International Conference on Harmonisation of Good Clinical Practice The first indicator in the regulation of drugs is the Food and Drugs Act established in the US in 1906. It is considered to be the result of very dangerous and even deadly drugs that could have been sold legally just like any other medical goods. For example, such drugs were ‘Grandma’s Secret’ and ‘Kopp’s Baby’s Friend’, which contained a huge amount of morphine. ‘Dr King’s Consumption Cure’ and ‘Dr Bull’s Cough Syrup‘ are examples of drugs which had large doses of morphine and chloroform as well. Legal and Regulatory StatusAlthough ICH GCP guidelines are recommended by the FDA,[2] they are not statutory in the United States. ICH GCP overview
CriticismGCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas:[3]
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".[4] See also
References1. ^Examples of clinical practice guidelines using 'good clinical practice' as lowest grade of recommendation{{Dead link|date=July 2018 |bot=InternetArchiveBot |fix-attempted=yes }} 2. ^{{Cite web|url=https://www.fda.gov/scienceresearch/specialtopics/runningclinicaltrials/default.htm|title=Clinical Trials and Human Subject Protection|last=Commissioner|first=Office of the|website=www.fda.gov|language=en|access-date=2018-11-01}} 3. ^{{cite journal | doi = 10.1016/S0140-6736(08)61936-4 | volume=373 | issue=9657 | title=Helsinki discords: FDA, ethics, and international drug trials | journal=The Lancet | pages=13–14| year=2009 | last1=Kimmelman | first1=Jonathan | last2=Weijer | first2=Charles | last3=Meslin | first3=Eric M }} 4. ^{{Cite book|publisher = Fourth Estate|publication-place = London|title = Bad Pharma|url = http://openlibrary.org/books/OL25682902M/Bad_Pharma|author = Ben Goldacre|publication-date = 2012}} External links{{Prone to spam|date=November 2013}}{{Z148}}
4 : Clinical research|Pharmaceutical industry|Good clinical practice|Good practice |
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