Research

Clinical trial phases – Overview and Phase 0

Clinical trial phases - Overview and Phase 0 1 MED4MIN.com Medicine Made Easy Research
Image Source: Yale News
"A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." - National Institute of Health (NIH) definition

Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefits in people, and mass-produce the product. Preclinical development starts before clinical trials and the main goals are to determine the safety and effectiveness of the intervention. If preclinical studies show that the therapy is safe and effective, clinical trials are started. Clinical trial phases are steps in the research to determine if an intervention would be beneficial or detrimental to humans and include Phases 0, I, II, III, IV, and V clinical studies. Understanding the basis of clinical trial phases will help researchers plan and implement clinical study protocols and, by doing so, improve the number of therapies coming to market for patients.

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