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Pages 68-76

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From page 68...
... 68 APPENDIX D Glossary and Acronyms This Glossary is intended to define terms and acronyms that are commonly used throughout this report as well as those terms and acronyms that are commonly used during the Food and Drug Administration (FDA) regulatory review process.
From page 69...
... APPENDIX D 69 Blinding: A study design feature that helps ensure that bias does not distort the conduct of a study or the integration of its results. In a single-blind study, only the clinical investigators are aware of which intervention (e.g., investigational drug or control)
From page 70...
... ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS70 Concomitant medication: An additional therapy or regimen that is either selfadministered or prescribed concurrently with a study therapy. Contract Research Organizations (CROs)
From page 71...
... APPENDIX D 71 Effectiveness: The desired measure of a drug's influence on a disease condition. Effectiveness must be proven by substantial evidence consisting of adequate and well-controlled investigations, including human studies by qualified experts, which prove that the drug will have the effect claimed in its labeling.
From page 72...
... ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS72 used to support applications for marketing permits (New Drug Applications)
From page 73...
... APPENDIX D 73 National Cancer Institute (NCI) : The federal government's principal agency for cancer research and training.
From page 74...
... ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS74 Pivotal trial: A clinical trial for a marketing application that is considered an essential component to supporting the safe and effective use of a medical product. Placebo: A pharmacologically inactive agent given to a patient as a substitute for an active agent.
From page 75...
... APPENDIX D 75 geriatric populations and patients with compromised liver or kidney function)
From page 76...
... ASSURING DATA QUALITY AND VALIDITY IN CLINICAL TRIALS76 McGraw-Hill Dictionary of Scientific and Technical Terms, 5th ed. Washington, D.C.: McGraw-Hill, Inc., 1994.

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