Questions for week 2

Q1. What kind of blinding strategy should this study choose? (unblinded, single, double or triple?) And what kind of biases will this study deal with? Q2. What is the anticipated non-compliance rate? Since treatments are self-administered regularly each day, some patients may forget to take treatments. How to solve this problem? Q3. What is the participation rate for source population? Q4. Do we need a two-sided test? In order to detect a meaningful effect, how powerful should this study become?

Q1. For trials of chronic conditions, the study time is normally very long. Is it necessary to measure several times during the study period? Q2. Is it necessary to consider other factors that may influence the result? Q3. For the FVC test, it is normally repeated several times on patient. Is it repeated immediately after the previous test, or followed at a different time of the day?

Q1. What is the expected difference between the two proposed treatments? ie. the expected effect size and the expected variability around this measure. Q2. What metric do the researchers propose using to measure the difference between treatments? ie. relative differences vs. absolute differences, percent changes etc. Q3. If patients are self-reporting how do the researchers expect to confirm reliability and validity of measurements?