Search results
Results From The WOW.Com Content Network
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness ( efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [1] [2] These research procedures are designed for the prevention, treatment, diagnosis or understanding ...
Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in the United States from 2004 to 2012 found the average cost of Phase I trials to be between $1.4 million and $6.6 million, depending on the type of disease.
A randomized controlled trial (or randomized control trial; [ 2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. [ 3][ 4]
Preclinical development. In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Pivotal trial. A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects. [1]
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. [ 1] The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP ...
A vaccine Phase I trial involves normal healthy subjects, each tested with either the candidate vaccine or a "control" treatment, typically a placebo or an adjuvant -containing cocktail, or an established vaccine (which might be intended to protect against a different pathogen ). The primary observation is for detection of safety (absence of an ...