Outline of 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
  • 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

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

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

See also

This article is issued from Offline. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.