Canadian Medical Guide > Analytical, Diagnostic and Therapeutic Techniques and Equipment > Investigative Techniques > Epidemiologic Methods > Epidemiologic Study Characteristics > Clinical Trials Terms and Definitions




Clinical Trials

Medical Definition: Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
Guide Notes: human & vet animals only; GEN or unspecified as to phase: index under specific phase (as CLINICAL TRIALS, PHASE I) instead if pertinent; IM for articles & books about clin trials as a method in med research; do not confuse with Publication Type CLINICAL T
Previously Indexed: Drug Evaluation (1974-1979)
Clinical Trials Categories.
Canadian Medical Guide Definition Clinical Trials, Phase I - 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.
Canadian Medical Guide Definition Clinical Trials, Phase II - Studies that are usually controlled to assess the effectiveness and dosage (if appropriate) of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques. These studies are performed on several hundred volunteers, including a limited number of patients with the target disease or disorder, and last about two years. This concept includes phase II studies conducted in both the U.S. and in other countries.
Canadian Medical Guide Definition Clinical Trials, Phase III - 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.
Canadian Medical Guide Definition Clinical Trials, Phase IV - 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.
Canadian Medical Guide Definition Controlled Clinical Trials - Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS. However, trials employing treatment allocation methods such as coin flips, odd-even numbers, patient social security numbers, days of the week, medical record numbers, or other such pseudo- or quasi-random processes, are simply designated as controlled clinical trials.
Canadian Medical Guide Definition Multicenter Studies - Controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children.

Clinical Trials Medical Definitions and Terms

CANADIAN MEDICAL GUIDE

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