Clinical Drug Trials

Abstract

1. Amy Mason, MD, MSc* 1. *Bayer Pharmaceuticals, Whippany, NJ 1. Code of Federal Regulations Title 21, Part 312, Investigational New Drug Application. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312. Accessed January 24, 2018 2. The Drug Development Process, Step 3: Clinical Research. US Food and Drug Administration. https://www.fda.gov/forpatients/approvals/drugs/ucm405622.htm. Accessed January 24, 2018 3. ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice E6(R1), Step 4 Version, June 10, 1996. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. https://www.ich.org/fileadmin/Public\_Web\_Site/ICH\_Products/Guidelines/Efficacy/E6/E6\_R1_Guideline.pdf. Accessed January 24, 2018 4. Guide to Clinical Trials. Spilker B . New York, NY: Raven Press; 1984:Xxii–Xxiii Have you ever thought about how the drug you prescribe made its way to the shelves of the pharmacy from which it will be dispensed? This process of drug discovery and development—of taking a drug from the laboratory to being available in the marketplace to treat individuals—may take up to 12 years and cost more than a billion dollars. In general, this timeline consists of approximately 5 years of laboratory research in which up to 10,000 potential substances are narrowed down to approximately 250 substances, which are then tested in animals and in vivo, after which time the single selected drug is ready to be tested in humans. Drug discovery is a highly regulated process designed to ensure the utmost safety to those who will use the medication: the ultimate goal is to bring drugs that are safe and effective to the market for individual use. Once a drug is ready for its first test in humans, it enters the 4 phases of clinical drug development: