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.
- Guidelines for the Conduct of Research Involving Human Subjects
- Belmont Report
- Nuremberg Code
- The Declaration of Helsinki- Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects
- Department of Health and Human Services (DHHS) regulations for the protection
of human subjects, 45 CFR 46
WORLD MEDICAL ASSOCIATION
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.
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 SingHealths 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 NHGs strategic goal of promoting the conduct of relevant research through better collaboration and harmonization of research initiatives amongst NHGs 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
- Malaysian Guidelines for Good Clinical Practice (GCP) (273 Kb) First edition; (662kb) Second Edition
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 (firstname.lastname@example.org)
The links to URL mentioned above are valid at the time of writing (17 July 1999).
Updated 25 April 2008.
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