View source for List of clinical research topics

'''[[Clinical research]]''' is the aspect of [[biomedical research]] that addresses the assessment of new [[drug|pharmaceutical]] and [[Biopharmaceutical|biological]] drugs, [[medical device]]s and [[vaccine]]s in humans.

{{See also|Glossary of clinical research}}
{{See also|List of biotechnology articles}}

==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
* [[Investigational product]]–a drug that is undergoing [[preclinical]] or [[clinical]] testing
* [[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==
{{main|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 (clinical trials)|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==
{{main|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==
{{main|Clinical trial management}}
* [[Clinical monitoring]]
* [[Clinical site]]
* [[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===
{{main|Contract research organization}}
{{main|List of contract research organizations}}
* [[Covance]]
* [[Parexel]]
* [[Quintiles]]
* [[Westat]]

==Data collection and management==
{{main|Clinical data acquisition}}
* [[Case report form]]
* [[Clinical data management system]]
* [[Data clarification form]]
* [[Electronic data capture]]
* [[Good Clinical Data Management Practice]]
* [[Patient diary]]
* [[Patient-reported outcome]]
* [[Remote Data Entry]]

===Medical term coding dictionaries===
{{main|Medical classification}}
* [[Uppsala Monitoring Centre]]
* [[COSTART]]
* [[MedDRA]]
* [[Systematized Nomenclature of Medicine]] (SNOMED)
* [[WHOART]]

===Clinical Data Interchange Standards Consortium===
{{main|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==
{{main|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]]
* [[Per-protocol 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]]
* [[Strengthening the reporting of observational studies in epidemiology]] (STROBE)

==Notable clinical studies==
{{see also|Clinical trials with surprising outcomes}}
* [[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==
{{Regulation of therapeutic goods in the United States}}
* [[Regulatory requirement]]s

===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 === <!-- Sorry Canada -->
* [[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]]
* [[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)

===Food and Drug Administration===
{{main|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

{{Medical research studies}}
{{List resources}}

[[Category:Clinical research| List of clinical research topics]]
[[Category:Medical lists|Clinical research topics]]
[[Category:Indexes of articles|Clinical research topics]]
[[Category:Lists of research topics]]
[[Category:2Fix]]