General topics

• Clinical significance
  Clinical significance
  In medicine and psychology, clinical significance refers to either of two related but slightly dissimilar concepts whereby certain findings or differences, even if measurable or statistically confirmed, either may or may not have additional significance, either by being of a magnitude that conveys...
  
  –a conclusion that an intervention has an effect that is of practical meaning to patients
• Drug discovery
  Drug discovery
  In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered or designed.In the past most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery...
  
  –the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy
• Drug development
  Drug development
  Drug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
  
  –the process of taking a new chemical through the stages necessary to allow testing in clinical trials
• Biotechnology
  Biotechnology
  Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
  
  –the technological application that uses biological systems, living organisms to make or modify products or processes for specific use
  • Biopharmaceutical
    Biopharmaceutical
    Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
    
    –a drug produced using biotechnology
• Clinical trial
  Clinical trial
  Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
  
  –an experiment with human subjects to assess safety and efficacy of drugs
  • Academic clinical trials
    Academic clinical trials
    Academic clinical trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of new drugs and devices....
    
    –clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities)
  • Clinical trials unit
    Clinical trials unit
    Clinical trials units are specialised biomedical research units which design, centrally coordinate and analyse clinical trials and other studies. Some CTUs specialise in different methodologies, such as randomised controlled trials, cluster randomised trials, surgical trials, and health services...
    
    –biomedical research units dedicated to conducting clinical trials
• Epidemiology
  Epidemiology
  Epidemiology is the study of health-event, health-characteristic, or health-determinant patterns in a population. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive...
  
  –the study of factors affecting the health and illness of populations
  • Epidemiological methods
    Epidemiological methods
    The science of epidemiology has matured significantly from the times of Hippocrates and John Snow. The techniques for gathering and analyzing epidemiological data vary depending on the type of disease being monitored but each study will have overarching similarities....
    
    –statistical techniques used in epidemiology
• Evidence-based medicine
  Evidence-based medicine
  Evidence-based medicine or evidence-based practice aims to apply the best available evidence gained from the scientific method to clinical decision making. It seeks to assess the strength of evidence of the risks and benefits of treatments and diagnostic tests...
  
  –the assessment of the quality of evidence relevant to the risks and benefits of medical treatments
• Pharmacology
  Pharmacology
  Pharmacology is the branch of medicine and biology concerned with the study of drug action. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function...
  
  –the study of the interactions that occur between a living organism and drugs that alter normal biochemical function
  • Biopharmacology
    Biopharmacology
    The biopharmacology is the branch of pharmacology that studies the use of biotechnologic originated drugs ....
    
    –the pharmacology of biopharmaceuticals
  • Clinical pharmacology
    Clinical pharmacology
    Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world...
    
    –the scientific discipline focused on rational drug development and utilization in therapeutics
  • Pharmacokinetics
    Pharmacokinetics
    Pharmacokinetics, sometimes abbreviated as PK, is a branch of pharmacology dedicated to the determination of the fate of substances administered externally to a living organism...
    
    –the study of the fate of drugs administered to the body
    • Bioequivalence
      Bioequivalence
      Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug...
      
      –the biological equivalence of two preparations of a drug
  • Pharmacodynamics
    Pharmacodynamics
    Pharmacodynamics is the study of the biochemical and physiological effects of drugs on the body or on microorganisms or parasites within or on the body and the mechanisms of drug action and the relationship between drug concentration and effect...
    
    –the study of the biochemical and physiological effects of drugs on the body
  • Pharmacometrics
    Pharmacometrics
    Pharmacometrics uses models based on pharmacology, physiology and disease for quantitative analysis of interactions between drugs and patients...
    
    –the science of interpreting and describing pharmacology in a quantitative fashion
• Pharmacovigilance
  Pharmacovigilance
  Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
  
  –the detection, assessment, understanding and prevention of adverse effects of medicines

Drug terminology

• Active ingredient
  Active ingredient
  An active ingredient is the substance of a pharmaceutical drug or a pharmaceutical ingredient and bulk active in medicine; in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient...
  
  –the substance in a drug that is pharmaceutically active
• Approved drug
  Approved drug
  In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then...
  
  –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
  European Medicines Agency
  The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
  
  
• Excipient
  Excipient
  An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an "active" substance may not be easily administered and absorbed by the human body; in such cases the substance in question may be dissolved into or...
  
  –an inactive substance used as a carrier for the active ingredients of a drug
• Investigational product
  Investigational product
  An investigational product is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved...
  
  –a drug that is undergoing preclinical or clinic
  Clinic
  A clinic is a health care facility that is primarily devoted to the care of outpatients...
  
  al testing
• Medicinal product
  Medicinal product
  A medicinal product is defined in the European Union as any substance or combination of substances presented for treating or preventing disease in human beings...
  
  –any substance or combination of substances used for treating or preventing disease in humans
• Off-label use
  Off-label use
  Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration...
  
  –the practice of prescribing a drug for an indication for which the drug has not been approved
• Orphan drug
  Orphan drug
  An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease...
  
  –a drug used to treat a rare medical condition, or orphan disease
• Placebo
  Placebo
  A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
  
  –a sham treatment given to a control group in a clinical study
• Prescription drug
  Prescription drug
  A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
  
  –a licensed medicine that can only be obtained by prescription from a doctor
• Standard treatment
  Standard treatment
  Standard treatment . The treatment that is normally provided to people with a given condition. In many studies, a control group receives the standard treatment while a treatment group receives the experimental treatment...
  
  –a currently available drug used in an active control clinical study

Types of study design

• Blind experiment
• Case report
  Case report
  In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence....
  
  
• Case series
  Case series
  A case series is a medical research descriptive study that tracks patients with a known exposure given similar treatment or examines their medical records for exposure and outcome. It can be retrospective or prospective and usually involves a smaller number of patients than more powerful...
  
  
• Case study
  Case study
  A case study is an intensive analysis of an individual unit stressing developmental factors in relation to context. The case study is common in social sciences and life sciences. Case studies may be descriptive or explanatory. The latter type is used to explore causation in order to find...
  
  
• Case-control study
• Clinical control group
  Clinical control group
  A clinical control group is a group of individuals, involved in a healthcare experimentation, who do not receive the treatment, in order to determine the effectiveness of the drug, supplement or treatment being tested....
  
  
• Cohort study
  Cohort study
  A cohort study or panel study is a form of longitudinal study used in medicine, social science, actuarial science, and ecology. It is an analysis of risk factors and follows a group of people who do not have the disease, and uses correlations to determine the absolute risk of subject contraction...
  
  
• Cross-sectional study
  Cross-sectional study
  Cross-sectional studies form a class of research methods that involve observation of all of a population, or a representative subset, at one specific point in time...
  
  
• Crossover study
  Crossover study
  A crossover study is a longitudinal study in which subjects receive a sequence of different treatments . While crossover studies can be observational studies, many important crossover studies are controlled experiments, which are discussed in this article...
  
  
• First-in-man study
  First-in-man study
  A first-in-man study is a clinical trial where a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time....
  
  
• Longitudinal study
  Longitudinal study
  A longitudinal study is a correlational research study that involves repeated observations of the same variables over long periods of time — often many decades. It is a type of observational study. Longitudinal studies are often used in psychology to study developmental trends across the...
  
  
• Minimisation
• Multicenter trial
  Multicenter trial
  A multicenter research trial is a clinical trial conducted at more than one medical center or clinic. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers...
  
  
• Nested case-control study
  Nested case-control study
  A nested case control study is a variation of a case-cohort study in which only a subset of controls from the cohort are compared to the incident cases. In a case-cohort study, all incident cases in the cohort are compared to a random subset of participants who do not develop the disease of interest...
  
  
• Observational study
  Observational study
  In epidemiology and statistics, an observational study draws inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator...
  
  
• Open-label trial
  Open-label trial
  An open-label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered....
  
  
• Placebo-controlled studies
  Placebo-controlled studies
  A Placebo-controlled study is a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed to have no real effect...
  
  
• Prospective cohort study
  Prospective cohort study
  A prospective cohort study is a cohort study that follows over time a group of similar individuals who differ with respect to certain factors under study, to determine how these factors affect rates of a certain outcome...
  
  
• Randomized controlled trial
  Randomized controlled trial
  A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
  
  
• Retrospective cohort study
  Retrospective cohort study
  A retrospective cohort study, also called a historic cohort study, generally means to take a look back at events that already have taken place...
  
  
• Run-in period
  Run-in period
  Run-in period is a period before a clinical trial is commenced when no treatment is given. The clinical data from this stage of a trial are only occasionally of value but can serve a valuable role in screening out ineligible or non-compliant participants, in ensuring that participants are in a...
  
  
• Seeding trial
  Seeding trial
  A seeding trial or marketing trial is a form of marketing, conducted in the name of research, designed to target product sampling towards selected consumers...
  
  
• Vaccine trial
  Vaccine trial
  A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed.-Methodology:A vaccine trial might involve forming two groups from the target population...
  
  

Study participant confidentiality and safety

• Adverse drug reaction
  Adverse drug reaction
  An adverse drug reaction is an expression that describes harm associated with the use of given medications at a normal dosage. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs...
  
  
• Adverse event
  Adverse event
  An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
  
  
• Council for International Organizations of Medical Sciences
  Council for International Organizations of Medical Sciences
  The Council for International Organizations of Medical Sciences is an international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949....
  
  
• Data confidentiality in clinical trials
  Data confidentiality in clinical trials
  Due to the EU Directive 2001/20/EC the inspectors appointed by the Member States have to maintain the confidentiality whenever they gain access to the confidential information as a result of the good clinical practice inspections in the accordance with the applicable national and international...
  
  
• Data monitoring committees
  Data Monitoring Committees
  A Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...
  
  
• Ethics Committee (European Union)
  Ethics Committee (European Union)
  The Ethics Committee, according to Directive 2001/20/EC, is an independent body in a Member State of the European Union, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and well being of human subjects involved in a clinical...
  
  
• EudraVigilance
  EudraVigilance
  EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area .The European...
  
  
• Exclusion criteria
  Exclusion criteria
  Exclusion criteria are the standards used to determine whether a person may or may not be allowed to participate in a clinical trial. The most important criteria used to determine appropriateness for clinical trial participation include age, sex, the type and stage of a disease, treatment history,...
  
  
• Great ape research ban
  Great Ape research ban
  A great ape research ban, or severe restrictions on the use of non-human great apes in research, is currently in place in the Netherlands, New Zealand, the United Kingdom, Sweden, Germany and Austria. These countries have ruled that chimpanzees, bonobos, gorillas, and orangutans are cognitively so...
  
  
• Inclusion criteria
  Inclusion criteria
  Inclusion criteria are a set of conditions that must be met in order to participate in a clinical trial. In other words - the standards used to determine whether a person may be allowed to participate in a clinical trial...
  
  
• Institutional review board
  Institutional review board
  An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
  
  
• MedWatch
  MedWatch
  MedWatch is the Food and Drug Administration’s reporting system for an adverse event or sentinel event, founded in 1993. An adverse event is any undesirable experience associated with the use of a medical product...
  
  
• Safety monitoring
  Safety monitoring
  Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution....
  
  
• Serious adverse event
  Serious adverse event
  A serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
  
  
• Suspected Adverse Reaction Surveillance Scheme
  Suspected Adverse Reaction Surveillance Scheme
  This article is about Veterinary Medicines. For Human Medicines, see the Yellow Card Scheme.The Suspect Adverse Reaction Surveillance Scheme used by the Veterinary Medicines Directorate is similar to the Human Yellow Card Scheme...
  
  

Clinical study management

• Clinical monitoring
  Clinical monitoring
  Clinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials...
  
  
• Clinical site
  Clinical site
  A clinical site is a medical facility staffed with a clinical investigator and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to...
  
  
• Clinical Trial Management System
  Clinical Trial Management System
  A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial...
  
  
• Good clinical practice
  Good clinical practice
  Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
  
  

Clinical research documents

• Clinical trial protocol
  Clinical trial protocol
  A clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
  
  
• Informed consent
  Informed consent
  Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
  
  
• Investigator's brochure
  Investigator's brochure
  In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information...
  
  
• Source document
  Source document
  For use of this term in accounting, see :Category:Accounting source documents.A source document is a document in which data collected for a clinical trial is first recorded...
  
  
• Standing operating procedure
  Standing operating procedure
  The terms standard operating procedure or SOP, is used in a variety of different contexts, such as healthcare, education, industry or the military. The military uses the term Standing Operating Procedure- rather than Standard- because an SOP refers to an organization's unique procedures, which are...
  
  

Clinical research personnel

• Clinical investigator
  Clinical investigator
  A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the...
  
  
• Clinical research associate
  Clinical research associate
  A clinical research associate is a profession defined by Good clinical practice guidelines .The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract...
  
  
• Clinical research coordinator
  Clinical research coordinator
  The Clinical Research Coordinator is responsible for conducting clinical trials using good clinical practice under the auspices of the Principal Investigator...
  
  

Contract research organizations

• Covance
  Covance
  Covance, Inc. , formerly Corning Incorporated, with headquarters in Princeton, New Jersey, USA, is a contract research organization , providing drug development and animal testing services...
  
  
• Parexel
  Parexel
  PAREXEL International is a contract research organization , based in Lowell, Massachusetts and founded in 1982 by Josef H. von Rickenbach and Anne Sayigh. It provides services for companies in the pharmaceutical, biotechnology and medical device industries, including consulting, clinical studies...
  
  
• Quintiles
  Quintiles
  Quintiles Transnational is a pharmaceutical services company offering clinical, commercial, consulting and capital services. The Quintiles network consists of more than 20,000 employees in 60 countries....
  
  
• Westat
  Westat
  Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments....
  
  

Data collection and management

• Case report form
  Case Report Form
  A Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site...
  
  
• Clinical data management system
  Clinical data management system
  A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS...
  
  
• Clinical data repository
  Clinical Data Repository
  A Clinical Data Repository is a real time database that consolidates data from a variety of clinical sources to present a unified view of a single patient. It is optimized to allow clinicians to retrieve data for a single patient rather than to identify a population of patients with common...
  
  
• Data clarification form
  Data clarification form
  A Data Clarification Form or Data Query Form is a questionnaire specifically used in clinical research. The DCF is the primary data clarification tool from the trial sponsor or Contract Research Organization towards the investigator to clarify discrepancies and ask the investigator for...
  
  
• Electronic data capture
  Electronic Data Capture
  An Electronic Data Capture system is a computerized system designedfor the collection of clinical data in electronic format for use mainly in human clinical trials.Typically, EDC systems provide:* a graphical user interface component for data entry...
  
  
• Good Clinical Data Management Practice
  Good Clinical Data Management Practice
  Good Clinical Data Management Practice is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form...
  
  
• Patient diary
  Patient diary
  A Patient Diary is a tool used during a clinical trial or a disease treatment to assess the patient's condition or to measure treatment compliance...
  
  
• Patient-reported outcome
  Patient-reported outcome
  A patient-reported outcome or PRO is a questionnaire used in a clinical trial or a clinical setting, where the responses are collected directly from the patient.-Overview:...
  
  
• Remote Data Entry
  Remote Data Entry
  A Remote Data Entry system is a computerized system designed for the collection of data in electronic format. The term is most commonly applied to a class of software used in the life sciences industry for collecting patient data from participants in clinical research studies—research of new...
  
  

Medical term coding dictionaries

• Uppsala Monitoring Centre
  Uppsala Monitoring Centre
  The Uppsala Monitoring Centre , located in Uppsala, Sweden, is the field name for the World Health Organization Collaborating Centre for International Drug Monitoring...
  
  
• COSTART
  COSTART
  The Coding Symbols for a Thesaurus of Adverse Reaction Terms was developed by the United States Food and Drug Administration for the coding, filing and retrieving of post-marketing adverse reaction reports. COSTART provides a method to deal with the variation in vocabulary used by those who...
  
  
• MedDRA
  MedDRA
  MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data...
  
  
• Systematized Nomenclature of Medicine
  Systematized Nomenclature of Medicine
  The Systematized Nomenclature of Medicine is a multiaxial, hierarchical classification system . As in any such system, a disease may be located in a body organ which results in a code in a topography axis and may lead to morphological alterations represented by a morphology code.-Purpose:SNOMED...
  
   (SNOMED)
• WHOART
  WHOART
  The WHO Adverse Reactions Terminology is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre , the World Health Organization Collaborating Centre for International Drug Monitoring.-Structure:* 32...
  
  

Clinical Data Interchange Standards Consortium

• Study Data Tabulation Model (SDTM
  SDTM
  SDTM defines a standard structure for human clinical trial data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration...
  
  )
• Standard for Exchange of Non-clinical Data (SEND)
• JANUS clinical trial data repository
  JANUS clinical trial data repository
  Janus clinical trial data repository is a clinical trial data repository standard as sanctioned by the U.S. Food and Drug Administration . It was named for the Roman god Janus , who had two faces, one that could see in the past and one that could see in the future...
  
  

Data analysis

• Censoring (clinical trials)
  Censoring (clinical trials)
  The term censoring is used in clinical trials to refer to mathematically removing a patient from the survival curve at the end of their follow-up time. Censoring a patient will reduce the sample size for analyzing after the time of the censorship...
  
  
• Effect size
  Effect size
  In statistics, an effect size is a measure of the strength of the relationship between two variables in a statistical population, or a sample-based estimate of that quantity...
  
  
• End point of clinical trials
  End point of clinical trials
  An endpoint is something which is measured in a clinical trial or study. Measuring the selected endpoints is the goal of a trial. The response rate and survival are examples of the endpoints....
  
  
• Hazard ratio
  Hazard ratio
  In survival analysis, the hazard ratio is the ratio of the hazard rates corresponding to the conditions described by two sets of explanatory variables. For example, in a drug study, the treated population may die at twice the rate per unit time as the control population. The hazard ratio would be...
  
  
• Meta-analysis
  Meta-analysis
  In statistics, a meta-analysis combines the results of several studies that address a set of related research hypotheses. In its simplest form, this is normally by identification of a common measure of effect size, for which a weighted average might be the output of a meta-analyses. Here the...
  
  
• Number needed to harm
  Number needed to harm
  The number needed to harm is an epidemiological measure that indicates how many patients need to be exposed to a risk-factor over a specific period to cause harm in one patient that would not otherwise have been harmed. It is defined as the inverse of the attributable risk...
  
  
• Number needed to treat
  Number needed to treat
  The number needed to treat is an epidemiological measure used in assessing the effectiveness of a health-care intervention, typically a treatment with medication. The NNT is the average number of patients who need to be treated to prevent one additional bad outcome...
  
  
• Odds ratio
  Odds ratio
  The odds ratio is a measure of effect size, describing the strength of association or non-independence between two binary data values. It is used as a descriptive statistic, and plays an important role in logistic regression...
  
  
• Intention to treat analysis
  Intention to treat analysis
  In epidemiology, an intention to treat analysis is an analysis based on the initial treatment intent, not on the treatment eventually administered. ITT analysis is intended to avoid various misleading artifacts that can arise in intervention research...
  
  
• Per-protocol analysis
  Per-protocol analysis
  In epidemiology, per-protocol analysis is a strategy of analysis in which only patients who complete the entire clinical trial are counted towards the final results. Intention to treat analysis uses data from all patients, including those who did not complete the study.- External links :* - of...
  
  
• Post-hoc analysis
  Post-hoc analysis
  Post-hoc analysis , in the context of design and analysis of experiments, refers to looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is sometimes called by critics data dredging to evoke the sense that the more one looks the more likely...
  
  
• Relative risk
  Relative risk
  In statistics and mathematical epidemiology, relative risk is the risk of an event relative to exposure. Relative risk is a ratio of the probability of the event occurring in the exposed group versus a non-exposed group....
  
  
• Risk-benefit analysis
  Risk-benefit analysis
  Risk–benefit analysis is the comparison of the risk of a situation to its related benefits. Exposure to personal risk is recognized as a normal aspect of everyday life. We accept a certain level of risk in our lives as necessary to achieve certain benefits. In most of these risks we feel as though...
  
  
• Sensitivity and specificity
  Sensitivity and specificity
  Sensitivity and specificity are statistical measures of the performance of a binary classification test, also known in statistics as classification function. Sensitivity measures the proportion of actual positives which are correctly identified as such Sensitivity and specificity are statistical...
  
  
• Subgroup analysis
  Subgroup analysis
  Subgroup analysis, in the context of design and analysis of experiments, refers to looking for pattern in a subset of the subjects....
  
  
• Substantial equivalence
  Substantial equivalence
  Substantial equivalence is a concept, developed by OECD in 1991, that maintains that a novel food should be considered the same as and as safe as a conventional food if it demonstrates the same characteristics and composition as the conventional food. Substantial equivalence is important from a...
  
  
• Surrogate endpoint
  Surrogate endpoint
  In clinical trials, a surrogate endpoint is a measure of effect of a certain treatment that may correlate with a real clinical endpoint but doesn't necessarily have a guaranteed relationship...
  
  
• Systematic review
  Systematic review
  A systematic review is a literature review focused on a research question that tries to identify, appraise, select and synthesize all high quality research evidence relevant to that question. Systematic reviews of high-quality randomized controlled trials are crucial to evidence-based medicine...
  
  
• Therapeutic effect
  Therapeutic effect
  A therapeutic effect is a consequence of a medical treatment of any kind, the results of which are judged to be desirable and beneficial. This is true whether the result was expected, unexpected, or even an unintended consequence of the treatment...
  
  

Results reporting

• Medical writing
  Medical writing
  Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research....
  
  
• Clinical trials publication
  Clinical trials publication
  Clinical trials publication is having research published in a peer reviewed journal following clinical trials. Most investigators will want to have such a publication but the nature of clinical trials may create special considerations and obstacles....
  
  
• Common Technical Document
  Common Technical Document
  The Common Technical Document is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency , the Food and Drug Administration and the Ministry of Health,...
  
  
• Consolidated Standards of Reporting Trials
  Consolidated Standards of Reporting Trials
  CONSORT encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials.-The CONSORT Statement:...
  
   (CONSORT)
• Electronic Common Technical Document
• Strengthening the reporting of observational studies in epidemiology
  Strengthening the reporting of observational studies in epidemiology
  The STROBE Statement is a reporting guideline including a checklist of 22 items that are considered essential for good reporting of observational studies....
  
   (STROBE)

Notable clinical studies

• British Doctors Study
  British Doctors Study
  The British Doctors Study is the generally accepted name of a prospective cohort study which ran from 1951 to 2001, and in 1956 provided convincing statistical proof that tobacco smoking increased the risk of lung cancer.-Context:...
  
  –in 1956 provided convincing statistical proof that tobacco smoking increased the risk of lung cancer.
• Framingham Heart Study
  Framingham Heart Study
  The Framingham Heart Study is a long-term, ongoing cardiovascular study on residents of the town of Framingham, Massachusetts. The study began in 1948 with 5,209 adult subjects from Framingham, and is now on its third generation of participants...
  
  –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
  Heart Protection Study
  The Heart Protection Study was a large randomized controlled trialrun by the Clinical Trial Service Unit, and fundedby the Medical Research Council and the British Heart Foundation in the United Kingdom...
  
  –the largest study to investigate the use of statins in the prevention of cardiovascular disease.
• International Studies of Infarct Survival
  International Studies of Infarct Survival
  The International Studies of Infarct Survival were four randomized controlled trials of several drugs for treating suspected acute myocardial infarction...
  
  –four randomized controlled trials of several drugs for treating suspected acute myocardial infarction.
• Intersalt study
  Intersalt study
  The Intersalt study was an observational study that showed an association between dietary salt, measured by urinary excretion, and blood pressure...
  
  –a landmark observational study that showed a strong association between dietary salt and risk of cardiovascular disease.
• JUPITER trial
  JUPITER trial
  The JUPITER trial is a study aimed at evaluating whether statins reduce heart attacks and strokes in people with normal cholesterol levels.- Study rationale :JUPITER was a randomized double-blind placebo-controlled study...
  
  –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
  Multicenter AIDS Cohort Study
  The Multicenter AIDS Cohort Study is an ongoing clinical study involving over 6,000 men infected with HIV. The study, a program of the Division of Acquired Immunodeficiency Syndrome, has been ongoing for over 25 years and has resulted in over 1,000 scientific publications....
  
   - a study of over 6,000 men infected with HIV that has been ongoing for over 25 years
• Stateville Penitentiary Malaria Study
  Stateville Penitentiary Malaria Study
  The Stateville Penitentiary malaria study was a controlled study of the effects of malaria on the prisoners of Stateville Penitentiary near Joliet, Illinois in the 1940s. The study was conducted by the Department of Medicine at the University of Chicago in conjunction with the United States Army...
  
  –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

• Regulatory requirement
  Regulatory requirement
  Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the Food and Drug Administration to establish these...
  
  s

European Union

• Directive 2001/20/EC
  Directive 2001/20/EC
  The Clinical Trials Directive is a European Union directive that aimed at...
  
  
• Directive 2001/83/EC
  Directive 2001/83/EC
  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use...
  
  
• Directive 2005/28/EC
  Directive 2005/28/EC
  The Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.The directive...
  
  
• Directive 65/65/EEC
• Directive 93/41/EEC
  Directive 93/41/EEC
  Council of the European Communities Directive 93/41/EEC of 14 June 1993 repealed Directive 87/22/EEC on the approximation of national measures relating to the marketing of high-technology medicinal products, as this directive had been superseded by Council Regulation No 2309/93 of 22 July 1993...
  
  
• Directive 95/46/EC on the protection of personal data
  Directive 95/46/EC on the protection of personal data
  The Data Protection Directive is a European Union directive which regulates the processing of personal data within the European Union...
  
  

United States

• Federal Food, Drug, and Cosmetic Act
  Federal Food, Drug, and Cosmetic Act
  The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
  
   (FD&C)–gives authority to the Food and Drug Administration
  Food and Drug Administration
  The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
  
   (FDA) to oversee the safety of food, drugs, and cosmetics.
  • Kefauver Harris Amendment
    Kefauver Harris Amendment
    The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval...
    
    –requires drug manufacturers to provide proof of the effectiveness and safety of drugs before approval.
• Prescription Drug User Fee Act
  Prescription Drug User Fee Act
  The Prescription Drug User Fee Act was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration to collect fees from drug manufacturers to fund the new drug approval process...
  
  –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
  Title 21 of the Code of Federal Regulations
  Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration , the Drug Enforcement Administration , and the Office of National Drug Control Policy ....
  
  –the section of Federal regulations that interprets and enforces FD&C.
• Title 21 CFR Part 11
  Title 21 CFR Part 11
  Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration guidelines on electronic records and electronic signatures in the United States...
  
  –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
  Health Insurance Portability and Accountability Act
  The Health Insurance Portability and Accountability Act of 1996 was enacted by the U.S. Congress and signed by President Bill Clinton in 1996. It was originally sponsored by Sen. Edward Kennedy and Sen. Nancy Kassebaum . Title I of HIPAA protects health insurance coverage for workers and their...
  
   (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
  Declaration of Helsinki
  The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...
  
   (United Nations)
• Food and Drugs Act
  Food and Drugs Act
  Food and Drugs Act is an Act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics...
  
   (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
  Australian Drug Evaluation Committee
  The Australian Drug Evaluation Committee or ADEC, was a committee that provided independent scientific advice to the Australian Government regarding therapeutic drugs. The committee was originally formed in 1963 and more recently authorised under the Therapeutic Goods Act 1989 as part of the...
  
  
• European Medicines Agency
  European Medicines Agency
  The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
  
  
• Federal Agency for Medicines and Health Products
  Federal Agency for Medicines and Health Products
  The Federal Agency for Medicines and Health Products of Belgium is responsible for the approval and registration of new medication in Belgium and for pharmacovigilance...
  
   (Belgium)
• Medicines and Healthcare products Regulatory Agency
  Medicines and Healthcare products Regulatory Agency
  The Medicines and Healthcare products Regulatory Agency is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe....
  
   (United Kingdom)
• Ministry of Health, Labour and Welfare (Japan)
  Ministry of Health, Labour and Welfare (Japan)
  The ' is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.It was formed with...
  
  
• Norwegian Medicines Agency
  Norwegian Medicines Agency
  The Norwegian Medicines Agency is the national, regulatory authority for new and existing medicines and the supply chain. The Agency is responsible for supervising the production, trials and marketing of medicines. It approves medicines and monitors their use, and ensures cost-efficient, effective...
  
  
• State Food and Drug Administration (China)
• Swedish Medical Products Agency
• Therapeutic Products Directorate
  Therapeutic Products Directorate
  Therapeutic Products Directorate is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States...
  
   (Canada)
• Therapeutic Goods Administration
  Therapeutic Goods Administration
  The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia . It is a Division of the Australian Department of Health and Ageing established under the Therapeutic Goods Act 1989 ...
  
   (Australia)

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
  Center for Biologics Evaluation and Research
  The Center for Biologics Evaluation and Research is one of six main centers for the U.S. Food and Drug Administration , which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Karen Midthun, M.D...
  
  —responsible for review and approval of biologic products, including vaccines, blood products, gene therapy and human cloning
• Center for Devices and Radiological Health
  Center for Devices and Radiological Health
  The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
  
  —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
  Center for Drug Evaluation and Research
  The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and...
  
  —responsible for review and approval of all drugs
• Office of Regulatory Affairs
  Office of Regulatory Affairs
  The Office of Regulatory Affairs is the part of the U.S. Food and Drug Administration that enforces the laws governing biologics, cosmetics, drugs, food, medical devices, radiation-emitting electronic devices, tobacco products, and veterinary products which may have potentially harmful side...
  
  —enforces FDA laws and regulations

Review and approval programs

• Investigational Device Exemption
  Investigational Device Exemption
  An Investigational Device Exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval application or a...
  
  —allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data
• Investigational New Drug
  Investigational New Drug
  The United States Food and Drug Administration's Investigational New Drug program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines before a marketing application for the drug has been approved...
  
  —allows an investigational drug to be used in a clinical study in order to collect safety and effectiveness data
• New Drug Application
  New drug application
  The New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
  
  —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
    FDA Fast Track Development Program
    The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials with the goal review time of 60 days...
    
    —a designation given to an NDA by the FDA that accelerates review and approval of new drugs

See also

• Glossary of clinical research
  Glossary of clinical research
  A glossary of terms used in clinical research.- A :* Activities of daily living* Adverse drug reaction* Adverse effect* Adverse event...
  
  
• List of biotechnology articles