Clinical trials -- Data processing -- Congresses : Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / Jonathan R. Davis [and others] editors
Clinical trials -- Government policy -- United States : Clinical trial subjects : adequate FDA protections? : hearing before the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, second session, April 22, 1998
1998
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Clinical trials -- Government policy -- United States -- Congresses : Transforming clinical research in the United States : challenges and opportunities : workshop summary / Rebecca A. English, Yeanwoo Lebovitz, and Robert B. Giffin, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies
2010
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Clinical trials -- Great Britain : Clinical Trials Explained : a Guide to Clinical Trials in the NHS for Healthcare Professionals
Clinical trials -- Methodology -- Congresses. : Clinical trials in infant nutrition : methodology, statistics, and ethicial issues / editors, Jay A. Perman, Jean Rey ; Nestlé Nutrition Services
Clinical trials -- New York (State) -- New York -- Drama : Subject / Welcome to Campfire presents ; created, directed & written by Tony Bordonaro & Ingrid Kapteyn ; choreographed by Tony Bordonaro & Ingrid Kapteyn ; produced by Welcome to Campfire
Here are entered works on testing the effectiveness or safety of drugs. Works on testing to identify the personal use or misuse of drugs are entered under Drug testing. Technical works on chemical analysis to determine the composition or presence of drugs are entered under Drugs--Analysis --subdivision Testing under individual drugs and groups of drugs; and subdivision Therapeutic use--Testing under individual chemicals and groups of chemicals, e.g. Copper--Therapeutic use--Testing; Insulin--Therapeutic use--Testing
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Clinical trials -- Older people : Clinical trials in older people / editors, Antonio Cherubini, Roberto Bernabei, Luigi Ferrucci, Niccolo Marchionni, Stephanie Studenski, Bruno Vellas
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries
Works about comparative studies to verify the effectiveness of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques determined in phase II studies. During these trials, patients are monitored closely by physicians to identify any adverse reactions from long-term use. These studies are performed on groups of patients large enough to identify clinically significant responses and usually last about three years. This concept includes phase III studies conducted in both the U.S. and in other countries
Planned post-marketing studies of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques that have been approved for general sale. These studies are often conducted to obtain additional data about the safety and efficacy of a product. This concept includes phase IV studies conducted in both the U.S. and in other countries
Works about studies performed to evaluate the safety of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in healthy subjects and to determine the safe dosage range (if appropriate). These tests also are used to determine pharmacologic and pharmacokinetic properties (toxicity, metabolism, absorption, elimination, and preferred route of administration). They involve a small number of persons and usually last about 1 year. This concept includes phase I studies conducted both in the U.S. and in other countries
