Hello, I'm Dr. Maurie Markman from Cancer Treatment Centers of America,
and Drexel University College of Medicine.
I'm going to be speaking on the topic of surrogate endpoints of efficacy
in cancer trials with a specific focus on the use of anti-neoplastic medications.
In oncology, not inappropriatly the traditional endpoint of
trials has been the impact of a strategy on overall survival.
Clearly from a historical perspective,
this is not only correct but it was easy to conduct trials with an endpoint of
survival since most of the therapies were
given at the beginning and either the impact was cure,
or unfortunately the patient may have died.
It was a very clear endpoint,
very often dramatic endpoint and that was the nature
of the clinical trials process with anti-neoplastic therapy.
However it was also recognized at the time that even
if cure was not possible or realistic,
it certainly might be possible to extend survival beyond
the point that would have occurred if a particular strategy had not been employed.
Now, that of course one can debate what extending survival means,
in other words the question could be,
does that mean a month, two months?
Does that mean a year, five years?
Of course, the endpoint for the trial would then be determined
by what the trialists and others would decide as being relevant,
and of course then this statistical design would be developed around that goal.
How much improvement does one have to see compared to,
for example a historical control or in fact but mostly
has been talked about and will be the focus of
this particular lecture, the randomized trial.
Then, one needs to ask the question what about
alternative endpoints that one might look at compared to overall survival?
That is again, the goal of this particular lecture was to talk about
other possible endpoints and why in fact it's
necessary to look at an endpoint other than overall survival.