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A per-protocol analysis represents a "best-case scenario" to reveal the effect of the drug being studied. However, by restricting the analysis to a selected patient population, it does not show all effects of the new drug. Further, adherence to treatment may be affected by other factors that influence the outcome. Accordingly, per-protocol ...
Randomized clinical trials analyzed by the intention-to-treat (ITT) approach provide unbiased comparisons among the treatment groups. Intention to treat analyses are done to avoid the effects of crossover and dropout, which may break the random assignment to the treatment groups in a study.
An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial. An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: Dose (of the study drug) Frequency of dosing interval; Methods of administration; Safety monitoring ...
[11] [8] The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. [8] Harmful effects discovered by Phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses ...
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A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol. [citation needed] The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned ...
A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
Proboscis extension reflex (PER) is the extension by an insect with an extendable proboscis (e.g. a bee or fly) of her proboscis (sticking out of her tongue) as a reflex to antennal stimulation. It is evoked when a sugar solution is touched to a bee's antenna.