Article citationsMore>>

US Department of Health and Human Services Food and Drug Administration (2012) Innovation or Stagnation: Challenges and Opportunity on the Critical Path to New Medical Products.
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html.

has been cited by the following article:

• TITLE: Clinical Trial Phases

  AUTHORS: Vicki L. Mahan

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

  JOURNAL NAME: International Journal of Clinical Medicine, Vol.5 No.21, December 29, 2014

  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.