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Clinical trial phase
Pronunciation
A part of the clinical research process that answers specific questions about whether treatments that are being studied work and are safe. Phase I trials test the best way to give a new treatment and the best dose. Phase II trials test whether a new treatment has an effect on the disease. Phase III trials compare the results of people taking a new treatment with the results of people taking the standard treatment. Phase IV trials are done using thousands of people after a treatment has been approved and marketed, to check for side effects that were not seen in the phase III trial. (NCI Dictionary)
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Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept…
A subject categorization in clinical trials based on the conditions a subject has previously met.
A legally binding document which governs the administrative/legal terms under which a Study will be conducted. This includes rights regarding publication, confidential…
The pharmacological substance that is being administered in the study.
