Clinical Trial Phases - International Journal of Clinical Medicine

IJCM > Vol.5 No.21, December 2014

Clinical Trial Phases ()

HTML XML

Download as PDF (Size: 2548KB) PP. 1374-1383

DOI: 10.4236/ijcm.2014.521175 13,152 Downloads 23,217 Views Citations

Author(s)

Vicki L. Mahan

Affiliation(s)

Department of Pediatric Cardiothoracic Surgery, St. Christopher’s Hospital for Children/Drexel University College of Medicine, Philadelphia, USA.

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.

KEYWORDS

Clinical Phases, Clinical Phase Trials, Preclinical Trials, Federal Drug Administration

Share and Cite:

Mahan, V. (2014) Clinical Trial Phases. International Journal of Clinical Medicine, 5, 1374-1383. doi: 10.4236/ijcm.2014.521175.

Journals Menu