Randomized Clinical Trials
The Primary Outcome Fails – What Next?
Projects:
Matched Randomization (Vanderbilt Wiki)
Adaptive designs
Trials that ended prematurely:
The Cardiac Insufficiency Bisoprolol Study (CIBIS) then followed up by CIBIS II
Towards a Revolution in COPD Health (TORCH) (p = 0.052 on primary outcome and awkward statement that `significant benefits in all other outcomes’)
Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) (primary outcome p = 0.08)
For data-based priors: Clinical Study Data Request