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Comparison of Clinical Trial Phases *Forms are subject to change. Check for the latest forms on the Tulane IRB web site. Tulane University Human Research Protection Program Comparison of Clinical Trial Phases OBJECTIVES PHASE I Human Pharmacology—Determine the metabolic and pharmacological actions and the maximally tolerated dose DATA FOCUS Vital signs Plasma and serum levels Adverse events DATA MONITORING All clinical trials require monitoring, but not necessarily by a data safety monitoring board (DSMB). Look to risk. Monitoring of data by PI & IRB usually suffices (except for novel drug, device or therapy with high or unknown safety profile) Single, ascending dose tiers Unblinded Uncontrolled NIH & FDA may require DSMB, depending on study NIH & FDA require DSMB Placebo controlled comparisons Active controlled comparisons Well-defined entry criteria Up to 1 month Healthy volunteers or individuals with the target disease (such as cancer or HIV) 20 to 80 Study of a single dose of Drug X in normal subjects Several months Individuals with target disease Several years Individuals with target disease 200 to 300 Double-blind study evaluating safety and efficacy of Drug X vs. placebo in patients with hypertension Hundreds to thousands Study of Drug X vs. standard treatment in hypertension study DURATION POPULATION SAMPLE SIZE EXAMPLE Bioavailability Drug-disease interactions Drug-drug interactions Efficacy at various doses Pharmakodynamics Pharmakokinetics Patient safety Dose response and tolerance Adverse events Efficacy PHASE III Therapeutic Confirmation--Obtain additional information about the effectiveness on clinical outcomes and evaluate the overall riskbenefit ratio in a demographically diverse sample Drug-disease interactions Drug-drug interactions Dosage intervals Risk-benefit information Efficacy and safety for subgroups FACTORS TO BE IDENTIFIED DESIGN FEATUERS Bioavailability Bioequivalence Dose proportionality Metabolism Pharmacodynamics Pharmacokinetics PHASE II Evaluate effectiveness, determine the short-term side effects and identify common risks for a specific population and disease Laboratory data Efficacy Adverse events Randomized Controlled 2-3 treatment arms Broader eligibility criteria PHASE IV Therapeutic Use-- Monitor ongoing safety in large populations and identify additional uses of the agent that might be approved by the FDA Epidemiological data Efficacy and safety within large, diverse populations Pharmacoeconomics Efficacy Pharmacoeconomics Epidemiology Adverse events NIH & FDA require DSMB Uncontrolled Observational Ongoing (following FDA approval) Individuals with target disease, as well as new age groups, genders, etc. Thousands Study of economic benefit of newlyapproved Drug X vs. standard treatment for hypertension 1 Issued: 9/29/09 Effective: 9/29/09 Form #: 712 Last Reviewed: 9/29/09 Last Revised: 9/29/09