| 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. (12 Dec 1998) |
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| 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. (12 Dec 1998) |
| 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. (12 Dec 1998) |
| 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. (12 Dec 1998) |
| clinician | A health professional engaged in the care of patients, as distinguished from one working in other areas. (05 Mar 2000) |
| clinicopathologic | Pertaining to the signs and symptoms manifested by a patient, and also the results of laboratory studies, as they relate to the findings in the gross and histologic examination of tissue by means of biopsy or autopsy, or both. (05 Mar 2000) |