ICH - GCP
Guidelines for Clinical Trials
ICH-GCP
Clinical studies should be carried out
according to International Conference on Harmonisation (ICH)
/ WHO Good Clinical Practice standards. This provides a
unified standard for the European Union (EU), Japan, and the
United States, as well as those of Australia, Canada, the
Nordic countries and the World Health Organisation (WHO).
Thus, any country that adopts this guideline technically
follows this same standard.
I have gathered some links which you may
find useful if you plan to do clinical research.
International
Conference on Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use
(ICH)
The International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is a unique project that
brings together the regulatory authorities of Europe, Japan
and the United States and experts from the pharmaceutical
industry in the three regions to discuss scientific and
technical aspects of product registration.
The purpose is to make recommendations on
ways to achieve greater harmonisation in the interpretation
and application of technical guidelines and requirements for
product registration in order to reduce or obviate the need
to duplicate the testing carried out during the research and
development of new medicines. The objective of such
harmonisation is a more economical use of human, animal and
material resources, and the elimination of unnecessary delay
in the global development and availability of new medicines
whilst maintaining safeguards on quality, safety and efficacy,
and regulatory obligations to protect public health. This
Mission is embodied in the Terms of Reference of ICH.
You will find the latest guidelines at this
site.
The
European Agency for the Evaluation of Medicinal Products (EMEA)
The main task of the EMEA is to
- Provide the Member States and the Community
institutions with the best possible scientific advice
on questions concerning quality, safety and efficacy
of medicinal products for human and veterinary use.
- Establish a multinational scientific expertise
through the mobilisation of existing national
resources in order to achieve a single evaluation via
a centralised or decentralised marketing
authorisation system.
- Organise speedy, transparent and efficient procedures
for the authorisation, surveillance and, where
appropriate, withdrawal of products in the European
Union.
- Advise companies on the conduct of pharmaceutical
research.
- Reinforce the supervision of existing medicinal
products in coordinating national pharmacovigilance
and inspection activities.
- Create the necessary databases and telecommunication
facilities to promote a more rational drug use.
FDA
Center for Drug Evaluation and Research (CDER)
The mission of FDA's Center for Drug Evaluation and
Research is to assure that safe and effective drugs are
available to the American people. The information below
provides an understanding of how CDER works to accomplish
this mission as it relates to new drug development and review. See the CDER Handbook.
- New Drug Development Process- An interactive chart that provides
an overview of the new drug development process, with
an emphasis on preclinical research and clinical
studies conducted by the drug's sponsor.
- Investigational New Drug (IND) Review
Process- An interactive
chart that provides an overview of CDER's
investigational new drug application process,
including how CDER determines if the product is
suitable for use in clinical trials.
- New Drug Application (NDA) Review Process- An interactive chart that provides an
overview of CDER's new drug application review
process, including how CDER determines the benefit:risk
profile of a drug product prior to approval for
marketing.
The
section on regulatory
guidelines is worth paying a visit.
Human Subject
Protections- Office of Human Subjects Research, NIH (OHSR)
OHSR
operates within the Office of the Deputy Director for
Intramural Research (DDIR), National Institutes of Health (NIH).
The NIH is part of the U.S. Public Health Service (PHS) which
is, in turn, an agency within the Department of Health and
Human Services (DHHS). The OHSR was established to help IRP
investigators understand and comply with the ethical
guidelines and regulatory requirements for research involving
human subjects. OHSR's overall goal is to promote and support
the IRP's efforts to conduct innovative research which
protects the rights and promotes the welfare of human
subjects. Have a look at the following sites.
DECLARATION
OF HELSINKI - 52nd
WMA General Assembly, Edinburgh, Scotland, October 2000 see 
(22 Kb)
Standard operating procedures for clinical
investigators ( WHO GCP SOP)
This document sets out the objectives of Standard
Operating Procedures and defines the Investigators'
responsibilities when undertaking a clinical study supported
by TDR. It provides instructions for planning, performing,
documenting and reporting clinical studies, and also provides
a useful glossary of terms.
PDF* (103Kb)
GCP IN SINGAPORE
Clinical Trials, SingHealth
The
primary objective of this initiative is to develop a core of
medical opinion leaders who will gain repute at a regional
and at an international level. This will serve to enhance
SingHealth’s reputation as a world-class health-care
center, and attract commercial companies selecting SingHealth
as a preferred partner for clinical trials.
Research and Development Office, National Health
Care Group
The RDO aims to achieve NHG’s strategic goal of
promoting the conduct of relevant research through better
collaboration and harmonization of research initiatives
amongst NHG’s Institutions. The RDO is envisioned as a
vibrant hub to provide key research support services
including administrative support for ethics review, to
nurture more research activities throughout NHG.
National
Medical Research Council
The National Medical Research
Council was appointed by the Minister for Health. Its mandate
is to oversee, co-ordinate and fund medical research in
Singapore.The Council drew up a strategy for the promotion of
medical research in the country.
The NMRC Clinical Trials and Epidemiology Research
Unit (CT&ERU)
The Clinical Trials & Epidemiology Research Unit (CTERU)
was established in November 1996 to provide the necessary
infrastructure to enable multicentre clinical trials and
epidemiological studies to be performed meeting international
standards for design, conduct and reporting. In particular,
the CTERU provides essential statistical, epidemiological,
data management and computer systems support for such studies
and has established a systematic reviews group to focus on
aspects of evidence-based medicine. In the context of
clinical trials, the Unit provides a randomisation service.
Although located close to the Ministry of Health, the
facilities and collaboration with the CTERU are available to
all clinical groups within Singapore, who are planning
studies of scientific importance and that are likely to
involve, or potentially lead to, multicentre collaboration
either within Singapore itself, the immediate region or
internationally. In priority terms, the CTERU will focus, but
not be confined to, research questions in areas identified as
of national importance by the Ministry of Health.
GCP IN MALAYSIA
Good Clinical Practice (GCP) is a standard for the design,
conduct, performance, monitoring, auditing, recording,
analyses and reporting of clinical trials that provides
assurance that the data and reported results are credible and
accurate and that the rights, integrity and confidentiality
of trial subjects are protected. It was launched in October
1999 and adapted (with minor modification) from the ICH
Harmonised Tripartite Guideline E6.
The aim of this booklet is to provide a comprehensive
guide on the processes involved in obtaining approval to
conduct clinical trials in Malaysia. Under the Control of
Drugs and Cosmetics Regulation, 1984, a clinical trial is
defined as "any investigation or series of
investigations on persons conducted by or under the
supervision of persons with scientific training or experience
for the purpose of finding about or determining the safety,
effectiveness and other effects of any product".
With that I let your "mouse" or your "keyboard"
do the "talking".
Till next month, "Happy Surfing".
Dr Muruga Vadivale Cyberdoc
(vadivale@geocities.com)
The links to URL mentioned above are valid at the time of
writing (17 July 1999).
Updated 25 April 2008.
This page can be accessed at http://www.vadscorner.com/internet29.html
or at http://www.vadscorner.com/mma_internet.html
or Vads Corner at http://www.vadscorner.com
