Outline of clinical research

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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[edit]

  • 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
  • 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[edit]

Types of study design[edit]

Clinical study design

Study participant confidentiality and safety[edit]

Human subject research

Clinical study management[edit]

Clinical research documents[edit]

Clinical research personnel[edit]

Contract research organizations[edit]

Contract research organization

Data collection and management[edit]

Clinical data acquisition

Medical term coding dictionaries[edit]

Medical classification

Clinical Data Interchange Standards Consortium[edit]

Clinical Data Interchange Standards Consortium

Data analysis[edit]

Analysis of clinical trials

Results reporting[edit]

Notable clinical studies[edit]

  • 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[edit]

European Union[edit]

United States[edit]

Other[edit]

Government agencies[edit]

United States Food and Drug Administration[edit]

Food and Drug Administration

Departments[edit]

Review and approval programs[edit]

See also[edit]