| Quality
Control of RCTs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| • | Very
detailed protocol, including endpoint metrics, a |
|||||||||||||
| hallmark
of a good study – done ex ante, not ex post |
||||||||||||||
| – | Use
of “surrogate markers” / intermediate outcomes |
|||||||||||||
| • | Accuracy
of case report forms |
|||||||||||||
| • | Trial
design isolates effect of MI? |
|||||||||||||
| • | What
if randomization “fails” in TX vs. control group |
|||||||||||||
| on
some dimensions? |
||||||||||||||
| – | Additional
statistical analysis |
|||||||||||||
| – | Site
effects? |
|||||||||||||
| • | Keeping
track of drop-outs, and reasons for drop-outs |
|||||||||||||