Reference no: EM133504156
TRUE or FALSE
1. Natural History studies can be helpful to determine which biomarker(s) and/or endpoint assessment(s) can accurately measure disease progress in an interventional study.
2. Sponsors must register a clinical trial in accordance with FDAAA but in return, they are guaranteed fast recruitment timelines because the public has access to the trial design.
3. A trial design requirement is to compare any new intervention to placebo.
4. Sample size calculations are performed to estimate the number of participants needed to see the difference between the interventions. Enrolling more than the minimum required is helpful.
5. Setting the Type I error at 0.05 or 5% means that you have a 5% chance of seeing a false positive or rejecting the null hypothesis when it's actually true.
6. Placebo, active control, and sham are all terms used to describe different control groups.
7. A case-control study is used when there is a group known to have an outcome and then one looks back in time to learn which participants had the exposure. This is a type of interventional trial.
8. Clinical Trial Agreements (CTAs) are a type of tech transfer with common hot button areas including data ownership, patent protection and publication policy.
9. In a multi-center trial, all CTAs much be fully executed for the trial to start.
10. Research questions are often posed as a null hypothesis that is assumed to be true and evidence is sought to disprove it.