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Quality of phase I clinical drug trials: Influence of organizational management factors.

07:00 EST 13th February 2020 | BioPortfolio

Summary of "Quality of phase I clinical drug trials: Influence of organizational management factors."

Focusing on the tolerance and pharmacokinetics of new drugs, phase I clinical drug trials are characterized by high risk, poor compliance and management difficulties. High-quality clinical drug trials ensure subjects' safety while extending new drug research and development. Many studies have examined micro-level concerns of trial design and implementation rather than macro-level factors. Accordingly, we evaluated the quality of phase I clinical drug trials (trial quality) and analysed the influence of organizational management factors from a macro-level perspective.

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This article was published in the following journal.

Name: Journal of clinical pharmacy and therapeutics
ISSN: 1365-2710
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Medical and Biotech [MESH] Definitions

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.

Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.

Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques after phase II trials. A large enough group of patients is studied and closely monitored by physicians for adverse response to long-term exposure, over a period of about three years in either the United States or a foreign country.

Works about randomized clinical trials that compare interventions in clinical settings and which look at a range of effectiveness outcomes and impacts.

Works about a study where participants are assigned to a treatment, procedure, or intervention by methods that are not random. Non-randomized clinical trials are sometimes referred to as quasi-experimental clinical trials or non-equivalent control group designs.

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