Category
page 1Clinical research

placebo
thumb|Placebos are typically inert tablets, such as sugar pills.
A placebo ( ) is a medicine or treatment intended to appear genuine to its recipient, but which has no pharmaceutical effect. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures.
clinical trial
human subject research in medicine
randomized controlled trial
experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group
nocebo
A nocebo effect is said to occur when a patient's expectations for a treatment cause the treatment to have a worse effect than it otherwise would have. For example, when a patient anticipates a side effect of a medication, they can experience that effect even if the "medication" is actually an inert substance. The complementary concept, the placebo effect, is said to occur when expectations improve an outcome.
evidence-based medicine
approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research

James Lind
Scottish physician and pioneer of naval hygiene
blind experiment
experiment in which information about the test is masked to reduce bias
COVID-19 drug development
preventative and therapeutic medications for COVID-19 infection
Pearl Index
Pearl Index
bioequivalence
thumb|right|335px|A bioequivalency profile comparison of 150 mg extended-release bupropion as produced by [[Impax Laboratories for Teva and Biovail for GlaxoSmithKline]]
standard operating procedure
set of step-by-step instructions compiled by an organization to help workers carry out routine operations
pharmacovigilance
Pharmacovigilance (PV, or PhV), also known as drug safety, is the discipline within pharmaceutical science that addresses the identification, evaluation, and mitigation of adverse effects and other drug-related problems associated with pharmaceutical products.
effect size
statistical measure of the magnitude of a phenomenon
human subject research project
systematic, scientific investigation that involves human beings as research subjects
clinical research
medical research using human test subjects
Good Clinical Practice
international quality standard for conducting clinical trials involving human subjects

prioritization
thumb|Creating a list may be the first step in establishing priorities.
thumb|This sign says it prioritizes Disability|the disabled, the elderly, pregnant people, and parents.
expanded access
program providing access to unapproved drugs or medical devices
Solidarity Trial
multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness
phase of clinical research
steps for human subject medical research
case report
publication type, detailed medical report on the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Initiative to promote public health
contract research organization
type of healthcare company
medical statistics
applications of statistics to medicine and the health sciences
clinical endpoint
occurrence or absence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials
retrospective cohort study
type of cohort study
clinical research associate
healthcare profession
intention to treat analysis
Form of study design and analysis for medical studies
Common Technical Document
internationally agreed format for drug approvals
hierarchy of evidence
heuristic ranking science research results
vaccine trial
clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed
case series
type of medical research study
Jadad scale
procedure to independently assess the methodological quality of a clinical trial
validation
process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages
microdosing
Microdosing, or micro-dosing, involves the administration of sub-therapeutic doses of drugs to study their effects in humans, aiming to gather preliminary data on safety, pharmacokinetics, and potential therapeutic benefits without producing significant physiological effects. This is called a "Phase 0 study" and is usually conducted before clinical Phase I to predict whether a drug is viable for the next phase of testing. Human microdosing aims to reduce the resources spent on non-viable drugs and the amount of testing done on animals.
non-specific effect of vaccines
as effects from vaccines other than those on the targeted disease
group in an experiment
group of experimental subjects which the study's design treats in a distinct way
serious adverse event
untoward medical occurrence in human medical trials that is sufficiently serious and meeting criteria such as resulting in death, life-threatening situation, inpatient hospitalization, disability or incapacity, birth defect, or permanent impairment
crossover study
type experimental design in a clinical trial
post-hoc analysis
statistical analyses that were not specified before the data were seen
medical writing
type of writing used in the medical, healthcare and pharmaceuticals professions
sham surgery
faked surgical intervention
Investigational New Drug
United States Food and Drug Administration's Investigational New Drug (IND) program
Clinical trial management system
software system
adverse event
bad outcome during experimental treatment
principal investigator
person(s) in charge of conducting a research project
approved drug
pharmaceutical product that successfully completed drug approval process
Linguistic validation
A process of investigating patient-reported outcome (PRO) measures and its translation.
case report form
in a clinical trial, the document showing all the evaluated patient data
Council for International Organizations of Medical Sciences
international non-governmental organization (NGO) dealing with ethics of health-related research
postmarketing surveillance
practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market
clinical study design
plan for research