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Clinical Trial Disclosure


Glossary of Terms
Most of the Glossary of Terms were taken from ClinicalTrials.gov website
  • Interventional - Studies in human beings in which individuals are assigned to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.
  • Investigational New Drug (IND) – An authorization given by the Food and Drug Administration (FDA) to administer a new drug, antibiotic drug, or biological drug to humans in a clinical trial. It also includes a biological product used in vitro for diagnostic purposes.
  • Partnered Product [Exclusive Licensee, Co-development Partner, Commercialization Partner ] – A product that is jointly developed and/or commercialized by Bristol-Myers Squibb and another company or research organization.
  • Phase I – Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
  • Phase II – Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
  • Phase III – Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
  • Phase IV – Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Other relevant glossaries:
http://www.clinicaltrials.gov/ct/info/glossary http://www.fda.gov/cder/drugsatfda/glossary.htm http://www.ifpma.org/clinicaltrials.html

 



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