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Government-Based Resources
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Clinical Trials.gov
(www.clinicaltrials.gov) |
The ClinicalTrials.gov is a website service provided by the U.S. National Institute of Health about government and private funded clinical research. In addition to educational information relating to clinical trials and a comprehensive glossary, this website hosts an extensive clinical trial database which includes a trial's purpose, who may participate, locations, and phone numbers for more details. |
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National Cancer Institute
(www.cancer.gov/clinicaltrials/learning) |
The National Cancer Institute (NCI) is a part of the National Institutes of Health (NIH). NCI is the U.S. Government's primary agency for cancer research and training. NCI hosts a comprehensive website where you will find medical, research, educational and legal information relating to cancer. |
U.S. Food & Drug Administration
(www.fda.gov) |
The Food and Drug Administration is an agency of the U.S. Department of Health and Human Services and is responsible for the safety and efficacy regulation of most types of drugs and medical devices. |
Office for Human Research Protections (OHRP)
(www.hhs.gov/ohrp) |
The Office for Human Research Protections (OHRP) provides guidance in protecting volunteers in clinical research that is conducted or supported by the U.S. government. OHRP provides clarification and guidance to research institutions, develops educational programs and materials, and promotes innovative approaches to enhancing human subject protections. |
Private-Based Resources
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AWARE FOR ALL: Center for Information and Study on Clinical Research Participation (CISCRP)
(http://ciscrp.org) |
The Center for Information and Study on Clinical Research Participation is a non-profit organization dedicated to educating and informing the public, patients, medical/research communities, the media, and policy makers about clinical research participation and the role that each party plays as a participant in the process. You will find information about programs and events promoting clinical research on the CISCRP website. |
| Center Watch (http://www.centerwatch.com) |
CenterWatch is a publishing and information services company which provides patients and their advocates with a variety of information services and educational materials on clinical research. The CenterWatch website hosts a comprehensive clinical trials database of industry-sponsored clinical trials throughout the nation and world. | |
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 (EMA)
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.
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.
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