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【Clinical】What are the review considerations for " treatment period, observation period, and time points of visits " for clinical trials?

刊登日期:2019-11-11  |  點閱次數 : 608 次 

The rationality of treatment period, observation period, and time points of visits in the study design will be evaluated as follows:

  1. Treatment period: Whether the length of treatment period is reasonable will be determined based on the character of the study drug and the main objective of the trial (efficacy or adverse reactions)
  2. Observation period: Observation period is usually planned for the purpose of collecting safety data, but sometimes it is planned for the purpose of observation of efficacy. For example, in antibiotics studies, subjects need to be observed for an extended period of time after the end of treatment for test of cure. The rationality of the length of the observation period will be judged by the purpose.
  3. Time points of visits: The frequency of visits shall take into account the feasibility of implementation. For example, whether the patients can cooperate and whether the time or frequency of visits is sufficient to monitor a specific drug adverse reaction. In addition, whether the observation items specified for the time points of visits are sufficient to protect the safety of subjects will also be evaluated.

 

(中文版)


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