Clinical trials
Definition:
Clinical trials are studies that involve researchers assigning participants- who are typically patients - to receive an intervention in the context of clinical care. The goal of clinical trials is to assess the safety and efficacy of new interventions such as drugs, diet, or medical devices.
Relevance:
Clinical trials are essential in the development of new drugs and in the assessment and re-purposing of already approved drugs. If the drug passes pre-clinical testing, it must then progress through clinical trials before it can be approved for use in patients. Clinical trials for the purposes of drug approval are separated into three distinct phases, each having a unique design and objectives (Phase I, II and III). Throughout this process, drug regulatory agencies ensure both safety as well as adherence to ethical standards. Clinical trials are also conducted for previously approved drugs, in which case safety and ethical considerations are typically addressed at the institutional level. Clinical trials can be done in one center but are frequently conducted on multiple sites.
Teaching Tips:
https://youtu.be/Gfv59Mesh20
https://experientialmodules.utoronto.ca/wp-content/uploads/articulate_uploads/Drug-Development/story.html
Linked terms: Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, Observational studies, NOAEL (No Observed Adverse Effect Level), LOAEL (Lowest Observed Adverse Effect Level)
Resources:
CTG Labs - NCBI. (n.d.). https://clinicaltrials.gov/study-basics/learn-about-studies#ClinicalTrials Drug Development. (n.d.). https://experientialmodules.utoronto.ca/wp-content/uploads/articulate_uploads/Drug-Development/story.html
What Are Clinical Trials and Studies? (n.d.). National Institute on Aging. https://www.nia.nih.gov/health/clinical-trials-and-studies/what-are-clinical-trials-and-studies
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