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- some type of occurrence of an event or outcome
- can be time of an event
- reflects functioning or survival
concentrating on an endpoint may
overlook other benefits
5 Qualities of an ideal endpoint
Prior to data collection, it is important to
define a single primary endpoint
Most trials measure
- used when benefit of just one endpoint is not sufficient
- ex. immediate cardiac failure (w/in 2 hours) and mid-term mortality (14 days)
Binary clinical endpoints
- "in our study we defined HTN as DBP >95 mmHG."
- simple to understand
- more clinically relevant
- "In our study we measured DBP in mmHG over a six month period"
- increased efficiency (fewer pt needed)
- Avoid arbitrary cut-off values
Why are randomized control trials not always practical?
- too costly (2 phase two trials = cost of 1 RTC (phase 3) trial)
- time consuming
- require too many patients
biomarker that is intended to substitute for a clinical endpoint
advantages of using surrogate markers
- faster trial completion and drug approval
- more frequent measurements
- provides insight to MOA and pharmacology
- guides dose selection
- more efficient screening of drug candidates
- less cost to mfg or sponsor
Validation of surrogate endpoints
- should be based on clinical insight and empirical evidence
- understand pathways and MOA
- requires meta-analysis of many trials
down fall of surrogate endpoints
easier to show effect of an intervention on clinical endpoints than to validate a surrogate marker
- two or three endpoints grouped together
- often in large CV trials
- can blunt meaningful endpoints
3 questions to validate composite endpoints
- are the components of the endpoints of similar importance to patients?
- did the more and less important end points occur with similar frequency?
- are the component endpoints likely to have similar relative risk reductions?
Definition of surrogate marker
- laboratory, radiologic or physically assessed measure believed to correlate with clinically important outcome
- ex. BP, BG...
concerns with surrogate markers
surrogate outcome may not correlate with clinically important outcomes
surrogate endpoint impact on study's power
increased since surrogate endpoints like BP are more responsive to intervensions than hard clinical endpoints such as stroke
definition of composite endpoint
endpoint consisting of two or more individual endpoints grouped together
concerns with composite endpoints
may amalgamate different endpoints of unequal clinical importance making it difficult to interpret effects of an intervention.
impact of composit endpoints on a study's power
increased since multiple endpoints are amalgamated together, increaseing event rates