Review Note
Last Update: 02/18/2024 05:30 AM
Current Deck: Part 2::6. High Yield Questions::Clinonc
PublishedCurrently Published Content
Front
What is the definition of a surrogate end point?
Give three examples of surrogate endpoints. What are the advantages and
disadvantages of using surrogate end points in oncology clinical trials? 4
marks
Back
A surrogate
endpoint is defined as a measure of effect of a specific treatment that may
correlate with a real critical endpoint (of intrinsic value to the patient such
as overall survival or QOL) but not necessarily have a guaranteed relationship.
Or simply a biomarker intended to substitute for a clinical endpoint.
Examples:
1. Progression free survival
2. Metastasis free survival
3. Ipsilateral invasive breast cancer
occurrence in DCIS
4. RANO/Resist criteria for tumour
response post treatment.
Advantages
-
Easier
and quicker to measure than the hard endpoints (eg overall survival)
-
Enables
trials to be conducted quickly at a reduced cost
-
Enables
trials to be run when there is a small number of events or long time to event
hence making it impractical to conduct a clinical trial in that setting to
reach a clinically significant outcome
-
Speeds
up treatment approval process, keeping up with new knowledge and medical
developments.
Disadvantages
-
Surrogate
endpoints may not be inherently meaningful to patients or intrinsically
valuable to patients such as overall survival or improved quality of life
-
Many
surrogates used in clinical practice are not clinically validated to prove a correlation
to the hard outcome.
-
Speeding
up drug or treatment approval is uncertain and may lead to unintended
consequences.
-
Measuring
surrogate endpoints may be complex – measurement error, evaluation bias,
attrition bias or informative censoring which weakens the association between
the surrogate and hard endpoint, hence loss of predictive value.
Further information, not for memorising (no card)
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