This workshop will be conducted in Japanese Language only.

Click Here to View Program in Japanese

In your daily work as a clinical research professional... you may have some questions which may be related to statistics, statistical method, study design, randomization, bias, interpretation of study results, bayes, missing data, consideration to discontinuation, and safety evaluation.

In conversation on such daily work, you may have matters:

• Of controversial issues (sometimes disagreement) with clinician / statistician

• Not in understanding of what the statistician says.

• Curious intention of statistician

Issues such as: inclusion/exclusion criteria for protocol, issues in conduct of clinical trials, difference of number of subjects in our study and competitor’s study may come up, and this class will help move you forward with no confusion. In clinical drug development/evaluation, it’s critical that the story how the drug fulfill the unmet medical needs based on the data, and understanding of the statistical concept is mandatory to realize the critical part for the story.

Target audience of this workshop is mainly the non-statistician professionals who work for clinical drug development/evaluation with such issues described above. Participants would understand basic statistical concepts fundamental to clinical trials with some interpretations of descriptions in regulatory guidelines and some related topics.

Thinking critically about data, making valid inferences, and understanding how statisticians are an essential element of clinical investigations which contribute to better decision-making and scientific productive discussion for all people who work for drug development. Such decision making and discussion require better collaboration between statistician and other experts for clinical trials.

This workshop will be ideal for clinical research professionals who work with statisticians in clinical development.