RCT class #11 Flashcards
What sensitivity analysis do we need for our proposal>
table showing how different sample sizes affect the outcome
What is success in an RCT (prior to lecture 11)?
LTFU <1 %
why is clinical equipoise important for RCTs
It forms moral foundation to the requirement that the health care of subjects not be disadvantaged by resarch participation
This is the moral foundation that subjects of trails are not disadvantaged by research participation
clinical equipoise
Where does the tenat of clinical equipoise come from?
Declaration of helsinki
example of clinicians being resistant to study equipoise
routine moitoring for intracerebral pressures after tbi by chestnut and others. no difference in intracerbral monitoring to clinical exam and serial monitoring.
What reduces awareness of how often negative rCTs occur?
publication bias (abscence of pub of negative results)
His example of failed new interventions
Neuroprotection.
What is erroms law?
The number of approved drugs per billion us dollars spent (inflation adjusted) has halved every 9 years since 1950
______ is the last step before approval of a new therapeutic agent
Registratoin
What is registration of a new therapeutic agent
submission of all trials and all necessary documentation for submission of an NDA (new drug appliaciton) with the FDA
Stage after stage III but prior to FDA approval
Registration.
What his take home message about success or not success from an RCT.
Success is subjective. be careful using this term
success of a phase II trial
A new intervention is found sufficiently promising to proceed to phase III.
success of a phase III trial in the classic sense>
a new intervention is superior to either placeob or std of care and is safe.
