A surrogate endpoint is a physical measurement of a specific outcome which is considered to be a valid predictor (or representative) of the real outcome or final result. Siro Clinical Research Institute

1. SURROGATE ENDPOINTS
PRESENTED BY :- DIGVIJAY PATIL, MAYURI BHOME
SIRO CLINICAL RESEARCH INSTITUTE WWW.SIROINSTITUTE.COM

2. Layout
 Introduction
 Types of clinical endpoints
 Surrogate endpoints
 Importance of surrogate endpoints
 Benefits for surrogate endpoints
 Advantages of surrogate endpoints
 Disadvantage of surrogate endpoints
References
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3. Introduction
 What are clinical trial endpoints?
A clinical trial’s endpoints measure the outcomes in the trial. When a trial
evaluates the efficacy of a new medical product or a new use for an approved
product, investigators may choose endpoints that directly measure the clinical
outcome they want to study.
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4. Types Of Endpoints
 Clinical Endpoint
 Surrogate Endpoint
 Biomarker Endpoint
 True Endpoint
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5. Surrogate Endpoint(1/3)
 Surrogate endpoints be used instead of clinical outcomes in some
clinical trials.
 A surrogate endpoint is a physical measurement of a specific outcome
which is considered to be a valid predictor (or representative) of the real
outcome or final result.
 Surrogate endpoints are used when the clinical outcomes, like strokes,
might take a very long time to study, or in cases where the clinical benefit
of improving the surrogate endpoint, such as controlling BP, is well
understood.
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6. Surrogate endpoint (2/3)
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Intervention
Disease
Surrogate
endpoint
Clinical “hard”
endpoint
Time

7. Surrogate Endpoints (3/3)
Surrogate endpoint is like a measurable indicator that can help us know what
the real result
Before a surrogate endpoint can be accepted in place of a clinical outcome,
extensive evidence must accumulate, including evidence from epidemiological
studies and clinical trials.
Usually clinical trials are needed to show that the surrogate endpoint can be
relied upon to predict, or correlate with, clinical benefit in a context of use
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8. Importance of Surrogate Endpoints
When a surrogate endpoint clearly predicts a beneficial effect through
appropriate studies, its use generally allows for more efficient drug development
programs.
Many clinical trials, using a range of different blood pressure lowering
medications, have demonstrated that reducing systolic blood pressure reduced
the risk of stroke.
 Measurement of reduction in the surrogate endpoint of systolic blood
pressure can stand in for the clinical outcome of stroke, and clinical trials
targeting the reduction of risk of stroke can be conducted more rapidly in
smaller populations using this validated surrogate endpoint.
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9. Advantage Of Surrogate Endpoints (1/2)
 Using surrogate outcomes reduces costs for manufacturers since it reduces
the duration of the clinical trial which means the new intervention could be
introduced to the market faster.
 Surrogate endpoints on some occasions, be useful since they could give more
balanced findings than using real outcomes.
 They may be used instead of stronger indicators, such as longer survival or
improved quality of life, because the results of the trial can be measured
sooner.
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10. Advantage Of Surrogate Endpoints (1/2)
 The assessment of "hard" primary clinical endpoints (such as death and heart
attack) often requires large long-term clinical trials which can be quite
expensive.
 The use of surrogate endpoints can allow trials to evaluate the efficacy of a
new drug or device more rapidly, more efficiently and more inexpensively.
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11. Disadvantages of surrogate endpoints (1/2)
 The surrogate endpoint may intuitively be hypothesized to be related to a
"hard endpoint" such as death or heart attack, but may not be.
While a surrogate endpoint may be related to a "hard endpoint" such as death
or heart attack, it is not clear that a reduction in the surrogate endpoint will lead
to an improvement in the "hard endpoint" in death or heart attack.
 While a surrogate endpoint may be related to a "hard endpoint, it may be an
causual association (the surrogate may not lie in the causal pathway to the "hard
endpoint" and changing the surrogate endpoint may not change the "hard
endpoint"
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12. Disadvantages of surrogate endpoints (2/2)
 The agent may reduce the surrogate endpoint, but due to off target toxicity,
may increase the risk of "hard endpoints" such as death or MI.
 The relationship between the surrogate endpoint and the "hard endpoint"
may be non-linear or may be a threshold effect.
 There have been a number of instances when studies using surrogate markers
have been used to show benefit from a particular treatment, but later, a repeat
study looking at endpoints has not shown a benefit, or even a harm.
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13. References
https://www.fda.gov/drugs/development-resources/surrogate-endpoint-resources-drug-and-
biologicdevelopment#:~:text=A%20surrogate%20endpoint%20is%20a,to%20predict%20that%20
clinical%20benefit
https://www.wikidoc.org/index.php/Surrogate_endpoint#:~:text=The%20use%20of%20a%20sur
rogate,of%20improvements%20in%20clinical%20outcomes
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1884846/
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