International Journal of Clinical Medicine

Volume 5, Issue 21 (December 2014)

ISSN Print: 2158-284X   ISSN Online: 2158-2882

Google-based Impact Factor: 0.52  Citations  h5-index & Ranking

Clinical Trial Phases

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DOI: 10.4236/ijcm.2014.521175    13,238 Downloads   23,394 Views  Citations
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ABSTRACT

Developers of drugs, biologicals, and medical devices must ensure product safety, demonstrate medical benefit in people, and mass produce the product. Preclinical development starts before clinical trials and the main goals are to determine 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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Mahan, V. (2014) Clinical Trial Phases. International Journal of Clinical Medicine, 5, 1374-1383. doi: 10.4236/ijcm.2014.521175.

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