List of clinical research topics

List of clinical research topics

Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.

Contents

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
  • 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

Types of study design

Study participant confidentiality and safety

Clinical study management

Clinical research documents

Clinical research personnel

Contract research organizations

Data collection and management

Medical term coding dictionaries

Clinical Data Interchange Standards Consortium

Data analysis

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

United States

Other

Government agencies

Food and Drug Administration

Departments

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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