Short description: Overview of and topical guide to clinical research
The following outline is provided as an overview of and topical guide to clinical research:
Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.
General topics
- Clinical significance – a conclusion that an intervention has an effect that is of practical meaning to patients
- Drug discovery – the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy
- Drug development – the process of taking a new chemical through the stages necessary to allow testing in clinical trials
- Biotechnology – the technological application that uses biological systems, living organisms to make or modify products or processes for specific use
- Clinical trial – an experiment with human subjects to assess safety and efficacy of drugs
- Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities)
- Clinical trials unit – biomedical research units dedicated to conducting clinical trials
- Epidemiology – the study of factors affecting the health and illness of populations
- Epidemiological methods – statistical techniques used in epidemiology
- Evidence-based medicine – the assessment of the quality of evidence relevant to the risks and benefits of medical treatments
- Pharmacology – the study of the interactions that occur between a living organism and drugs that alter normal biochemical function
- Biopharmacology – the pharmacology of biopharmaceuticals
- Clinical pharmacology – the scientific discipline focused on rational drug development and utilization in therapeutics
- Pharmacokinetics – the study of the fate of drugs administered to the body
- Bioequivalence – the biological equivalence of two preparations of a drug
- Pharmacodynamics – the study of the biochemical and physiological effects of drugs on the body
- Pharmacometrics – the science of interpreting and describing pharmacology in a quantitative fashion
- Pharmacovigilance – the detection, assessment, understanding and prevention of adverse effects of medicines
Drug terminology
- Active ingredient – the substance in a drug that is pharmaceutically active
- Approved drug – a drug that has been approved for marketing by a regulatory body such as the U.S. Food and Drug Administration or the European Medicines Agency
- Excipient – an inactive substance used as a carrier for the active ingredients of a drug
- Medicinal product – any substance or combination of substances used for treating or preventing disease in humans
- Off-label use – the practice of prescribing a drug for an indication for which the drug has not been approved
- Orphan drug – a drug used to treat a rare medical condition, or orphan disease
- Placebo – a sham treatment given to a control group in a clinical study
- Prescription drug – a licensed medicine that can only be obtained by prescription from a doctor
- Standard treatment – a currently available drug used in an active control clinical study
Types of study design
Clinical study design
Study participant confidentiality and safety
Human subject research
Clinical study management
Clinical research documents
Clinical research personnel
Contract research organizations
Contract research organization
- PPD
- Covance
- Parexel
- Quintiles
- Westat
Data collection and management
Clinical data acquisition
Medical term coding dictionaries
Medical classification
Clinical Data Interchange Standards Consortium
Clinical Data Interchange Standards Consortium
- Study Data Tabulation Model (SDTM)
- Standard for Exchange of Non-clinical Data (SEND)
- JANUS clinical trial data repository
Data analysis
Analysis of clinical trials
Results reporting
Notable clinical studies
- British Doctors Study – in 1956 provided convincing statistical proof that tobacco smoking increased the risk of lung cancer.
- Framingham Heart Study – a cardiovascular study based in Framingham, Massachusetts, which began in 1948 with 5,209, and is now on its third generation of participants.
- Heart Protection Study – the largest study to investigate the use of statins in the prevention of cardiovascular disease.
- International Studies of Infarct Survival – four randomized controlled trials of several drugs for treating suspected acute myocardial infarction.
- Intersalt study – a landmark observational study that showed a strong association between dietary salt and risk of cardiovascular disease.
- JUPITER trial – the first clinical trial to demonstrate that statin therapy may provide benefit to patients with low-to-normal LDL levels and no known cardiovascular disease.
- Multicenter AIDS Cohort Study – a study of over 6,000 men infected with HIV that has been ongoing for over 25 years
- Stateville Penitentiary Malaria Study – a controlled study of the effects of malaria on the inmates of Stateville Penitentiary near Joliet, Illinois.
- Tuskegee Study of Untreated Syphilis in the Negro Male – a clinical study, conducted between 1932 and 1972 in Tuskegee, Alabama studied the natural progression of the disease if left untreated.
Legislation, regulations and guidances
European Union
- Directive 2001/20/EC
- Directive 2001/83/EC
- Directive 2005/28/EC
- Directive 65/65/EEC
- Directive 93/41/EEC
- Directive 95/46/EC on the protection of personal data
United States
Other
- Declaration of Helsinki (United Nations)
- Food and Drugs Act (Canada)
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (European Union, Japan, and United States)
Government agencies
United States Food and Drug Administration
Food and Drug Administration
Departments
- Commissioner of Food and Drugs – as head of the Food and Drug Administration, the commissioner reports to the Secretary of the Department of Health and Human Services
- Center for Biologics Evaluation and Research – responsible for review and approval of biologic products, including vaccines, blood products, gene therapy and human cloning
- Center for Devices and Radiological Health – responsible for review and approval of medical devices and safety of non-medical equipment that emit certain types of radiation
- Center for Drug Evaluation and Research – responsible for review and approval of all drugs
- Office of Regulatory Affairs – enforces FDA laws and regulations
Review and approval programs
- Investigational Device Exemption – allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data
- Investigational New Drug – allows an investigational drug to be used in a clinical study in order to collect safety and effectiveness data
- New Drug Application – a submission to the FDA by a pharmaceutical company for review and approval of a new drug
- Abbreviated New Drug Application – a submission to the FDA review and approval of a generic drug
- FDA Fast Track Development Program – a designation given to an NDA by the FDA that accelerates review and approval of new drugs
See also
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