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
 * Biopharmaceutical – a drug produced using biotechnology
 * 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
 * Blind experiment
 * Case report
 * Case series
 * Case study
 * Case-control study
 * Clinical control group
 * Cohort study
 * Cross-sectional study
 * Crossover study
 * First-in-man study
 * Longitudinal study
 * Minimisation
 * Multicenter trial
 * Nested case-control study
 * Observational study
 * Open-label trial
 * Placebo-controlled studies
 * Prospective cohort study
 * Randomized controlled trial
 * Retrospective cohort study
 * Run-in period
 * Seeding trial
 * Vaccine trial

Study participant confidentiality and safety
Human subject research
 * Adverse drug reaction
 * Adverse event
 * Council for International Organizations of Medical Sciences
 * Data confidentiality in clinical trials
 * Data monitoring committees
 * Ethics Committee (European Union)
 * EudraVigilance
 * Exclusion criteria
 * Great ape research ban
 * Inclusion criteria
 * Institutional review board
 * MedWatch
 * Safety monitoring
 * Serious adverse event
 * Suspected Adverse Reaction Surveillance Scheme

Clinical study management

 * Clinical monitoring
 * Clinical Trial Management System
 * Good clinical practice

Clinical research documents

 * Clinical trial protocol
 * Informed consent
 * Investigator's brochure
 * Source document
 * Standing operating procedure

Clinical research personnel

 * Clinical investigator
 * Clinical research associate
 * Clinical research coordinator

Contract research organizations
Contract research organization
 * PPD
 * Covance
 * Parexel
 * Quintiles
 * Westat

Data collection and management
Clinical data acquisition
 * Case report form
 * Clinical data management system
 * Clinical data repository
 * Data clarification form
 * Electronic data capture
 * Good clinical data management practice
 * Patient diary
 * Patient-reported outcome
 * Remote data entry

Medical term coding dictionaries
Medical classification
 * Uppsala Monitoring Centre
 * COSTART
 * MedDRA
 * Systematized Nomenclature of Medicine (SNOMED)
 * WHOART
 * Common Terminology Criteria for Adverse Events

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
 * Censoring (clinical trials)
 * Effect size
 * End point of clinical trials
 * Hazard ratio
 * Meta-analysis
 * Number needed to harm
 * Number needed to treat
 * Odds ratio
 * Intention to treat analysis
 * Post-hoc analysis
 * Relative risk
 * Risk–benefit analysis
 * Sensitivity and specificity
 * Subgroup analysis
 * Substantial equivalence
 * Surrogate endpoint
 * Systematic review
 * Therapeutic effect

Results reporting

 * Medical writing
 * Clinical trials publication
 * Common Technical Document
 * Consolidated Standards of Reporting Trials (CONSORT)
 * Electronic Common Technical Document
 * Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
 * Strengthening the reporting of observational studies in epidemiology (STROBE)
 * Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM)

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.

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

 * Federal Food, Drug, and Cosmetic Act (FD&C) – gives authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
 * Kefauver Harris Amendment – requires drug manufacturers to provide proof of the effectiveness and safety of drugs before approval.
 * Prescription Drug User Fee Act – allows the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
 * Title 21 of the Code of Federal Regulations – the section of Federal regulations that interprets and enforces FD&C.
 * Title 21 CFR Part 11 – defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
 * Health Insurance Portability and Accountability Act (HIPAA) – Title II of HIPAA addresses the security and privacy of health data, including data collected from subjects in clinical research.

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

 * Australian Drug Evaluation Committee
 * European Medicines Agency
 * Committee for Medicinal Products for Human Use
 * Federal Agency for Medicines and Health Products (Belgium)
 * Medicines and Healthcare products Regulatory Agency (United Kingdom)
 * Ministry of Health, Labour and Welfare (Japan)
 * Norwegian Medicines Agency
 * State Food and Drug Administration (China)
 * Swedish Medical Products Agency
 * Therapeutic Products Directorate (Canada)
 * Therapeutic Goods Administration (Australia)

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