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Informed Consent and Phase I Trials: Cognitive Failure and Additional Challenges to Informed Decision Making.

07:00 EST 15th November 2018 | BioPortfolio

Summary of "Informed Consent and Phase I Trials: Cognitive Failure and Additional Challenges to Informed Decision Making."

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This article was published in the following journal.

Name: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Pages: JCO1801136

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Medical and Biotech [MESH] Definitions

Informed consent given by someone other than the patient or research subject.

Informed consent given by a parent on behalf of a minor or otherwise incompetent child.

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.

Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies. (Campbell's Psychiatric Dictionary, 9th ed.)

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.

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Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


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