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Intervention group The group receiving the study agent that is being tested in a clinical trial or clinical study. (NCI) Intervention name The generic name of the precise intervention being studied. (NLM) Intra-rater reliability The property of yielding equivalent results when used by the same rater on different occasions. (ICH E9) Investigational
ITT analysis is intended to avoid various misleading artifacts that can arise in intervention research such as non-random attrition of participants from the study or crossover. ITT is also simpler than other forms of study design and analysis, because it does not require observation of compliance status for units assigned to different ...
A clinical control group can be a placebo arm or it can involve an old method used to address a clinical outcome when testing a new idea. For example in a study released by the British Medical Journal, in 1995 studying the effects of strict blood pressure control versus more relaxed blood pressure control in diabetic patients, the clinical control group was the diabetic patients that did not ...
Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
A quasi-experiment is an empirical interventional study used to estimate the causal impact of an intervention on target population without random assignment.Quasi-experimental research shares similarities with the traditional experimental design or randomized controlled trial, but it specifically lacks the element of random assignment to treatment or control.
A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be ...
A clinical trial participant receives an injection. Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further ...
A megastudy or mega-study is a research study in which a large number of different treatments or interventions are tested at the same time, on the same sample or similar samples, using a common outcome measure, and using the same experimental protocol. [1] [2] [3] This research design ensures the outcomes across interventions are comparable.