Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...
s involving human subjects. GCP follows the
(ICH), and enforces tight guidelines on
ethical aspects of
clinical research
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatmen ...
.
High standards are required in terms of comprehensive documentation for the
clinical protocol
Protocol may refer to:
Sociology and politics
* Protocol (politics), a formal agreement between nation states
* Protocol (diplomacy), the etiquette of diplomacy and affairs of state
* Etiquette, a code of personal behavior
Science and technology
...
, record keeping, training, and facilities, including
computers
A computer is a machine that can be programmed to carry out sequences of arithmetic or logical operations (computation) automatically. Modern digital electronic computers can perform generic sets of operations known as programs. These prog ...
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 associate
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in vari ...
s.
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
* European Union: In the EU, Good Clinical Practice (Directive 2001/20/EC) is backed and regulated by formal legislation contained in the Clinical Trial Directive (Officially Directive 2001/20/EC). 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), 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.
ICH GCP overview
* Glossary
*Principles of ICH GCP
*Guidelines for:
**
institutional review board (IRB) / independent ethics committee (IEC)
**investigator
** trial sponsor (industrial, academic)
**
clinical trial protocol
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure succe ...
and protocol amendments
**
investigator's brochure
**essential documents
Criticism
GCP has been called 'a less morally authoritative document' than the
Declaration of Helsinki
The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA ...
, lacking moral principles and guidance in the following areas:
* 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
''Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients'' is a book by the British physician and academic Ben Goldacre about the pharmaceutical industry, its relationship with the medical profession, and the extent to which it control ...
'',
Ben Goldacre
Ben Michael Goldacre (born 20 May 1974) is a British physician, academic and science writer. He is the first Bennett Professor of Evidence-Based Medicine and director of the Bennett Institute for Applied Data Science at the University of Oxford ...
mentions these criticisms and notes that the GCP rules "aren't terrible...
hey aremore focused on procedures, while Helsinki clearly articulates moral principles".
See also
*
Data monitoring committees
*
Directive 2001/20/EC
The Clinical Trials Directive (Officially Directive 2001/20/EC of 4 April 2001, of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to implementati ...
(
European Union)
*
Drug development
*
EudraVigilance
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or bein ...
*
European Forum for Good Clinical Practice
The European Forum for Good Clinical Practices (EFGCP) is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe. The EFGCP is committed to the development of the standards for the pro ...
(EFGCP)
*
European Medicines Agency (EMEA)
*
GxP
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
A "c" or "C" is ...
*
Human experimentation in the United States
Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, an ...
*
Institutional review board
*
Inverse benefit law
The inverse benefit law states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law, ...
*
Medical ethics
*
Pharmacovigilance
*
Pharmaceutical company
References
{{reflist
External links
ICH Topic E 6 (R2)(from U.S.
Food and Drug Administration)
* Some Relevant
UK Statutory Instrument
In many countries, a statutory instrument is a form of delegated legislation.
United Kingdom
Statutory instruments are the principal form of delegated or secondary legislation in the United Kingdom.
National government
Statutory instrumen ...
s
*
The Medicines for Human Use (Clinical Trials) Regulations 2004*
**
ttp://www.opsi.gov.uk/si/si2006/20062984.htm The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006
Clinical research
Pharmaceutical industry
Good practice