Module 14 2022

21/03/2022

Set investigation endpoints

• QUIZ QUESTION: What is NOT true about ENDPOINTS? • They define an answer to questions posed by the objectives of clinical investigation. • They are observable, objectively determined measures directly related to the biological effects of the clinical conditions of patient receiving the device intervention. • They address the intended purpose, clinical benefits, performance and safety of the device. • They are determined in conjunction with industry experts, regulators, stakeholders, etc. • None of the above

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

13

Calculate sample size

• The number of patients is large enough to reliably answer to the questions addressed whilst minimizing the exposure of subjects to risk. • QUIZ QUESTION: Which of the following is/are not required for determining an appropriate sample size ? • specification of a primary variable and its variability • the anticipated effect size • the null hypothesis and the alternative hypothesis

• the probability of erroneously rejecting the null hypothesis • the probability of erroneously accepting the null hypothesis • All of the above are required

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

14

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