Knowra Clinical trial Clinical trial A research study involving human participants that evaluates the effects, safety, or efficacy of a health-related intervention. Its design assigns or observes interventions under a protocol to produce evidence about health outcomes.
Randomized controlled trial : A clinical trial that assigns participants to intervention groups by chance and compares their outcomes. Random allocation helps separate an intervention’s effects from differences between participants.
Informed consent : A voluntary agreement to participate made after receiving relevant information about a study and its risks. Participants must understand the study before agreeing to join.
Phase I clinical trial : An early-stage trial that primarily evaluates an intervention’s safety, tolerability, and dosing. This phase often provides the first systematic human evidence about a new intervention.
Observational study : A study that examines exposures and outcomes without assigning participants to an intervention. Unlike an interventional trial, it studies treatment choices made outside researcher assignment.
Blinding : A design practice that withholds group assignments from participants, clinicians, or assessors to limit bias. Masking group assignments can reduce biased care and outcome assessment.
Eligibility criteria : The inclusion and exclusion rules that determine who may participate in a study. These rules define the population represented by a trial’s findings.
Phase II clinical trial : A trial that explores an intervention’s efficacy and continues evaluating its safety in a defined patient group. These studies test whether an intervention shows enough promise for larger trials.
Pragmatic clinical trial : A trial designed to estimate how an intervention works in routine clinical practice. It prioritizes real-world relevance over the tightly controlled conditions of many explanatory trials.
Control group : A study group that receives a comparator, such as standard care, placebo, or no intervention. The comparator provides a reference for interpreting outcomes in the intervention group.
Institutional review board : An independent committee that reviews research involving people to protect participants’ rights and welfare. Ethics review checks that risks, consent, and safeguards are acceptable before a trial begins.
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