From: The ethics of ‘Trials within Cohorts’ (TwiCs): 2nd international symposium
1. Eligibility: How similar are trial participants to those in intended usual care? |
2. Recruitment: Is trial recruitment process similar to that of entry into usual care? |
3. Setting: How similar is the trial setting to the intended usual care setting? |
4. Organisation: Are resources added for care in the trial beyond those in usual care? |
5. Flexibility-delivery: Are clinicians constrained differently from usual care? |
6. Flexibility-adherence: Are participants selected, burdened beyond usual care? |
7. Follow up: Are participants followed up more closely that in usual care? |
8. Primary outcome: How similar are trial outcomes to usual care criteria for success? |
9. Primary analysis: Are all participants included in the main analysis? |