Registration for a live webinar on 'Neuroleptic malignant syndrome' is now open.
See webinar detailsWe noted you are experiencing viewing problems
-
Check with your IT department that JWPlatform, JWPlayer and Amazon AWS & CloudFront are not being blocked by your network. The relevant domains are *.jwplatform.com, *.jwpsrv.com, *.jwpcdn.com, jwpltx.com, jwpsrv.a.ssl.fastly.net, *.amazonaws.com and *.cloudfront.net. The relevant ports are 80 and 443.
-
Check the following talk links to see which ones work correctly:
Auto Mode
HTTP Progressive Download Send us your results from the above test links at access@hstalks.com and we will contact you with further advice on troubleshooting your viewing problems. -
No luck yet? More tips for troubleshooting viewing issues
-
Contact HST Support access@hstalks.com
-
Please review our troubleshooting guide for tips and advice on resolving your viewing problems.
-
For additional help, please don't hesitate to contact HST support access@hstalks.com
We hope you have enjoyed this limited-length demo
This is a limited length demo talk; you may
login or
review methods of
obtaining more access.
Printable Handouts
Navigable Slide Index
- Introduction
- The traditional endpoint in oncology
- Improvement in overall survival (OS)
- Improvement in OS - relevant factors
- Improvement in OS - requirements and concerns
- Surrogates for overall survival
- Conceptual models cancer disease management
- Difficulty with "chronic disease model"
- AOC as a paradigm for surrogate endpoint issues
- AOC "standard of care"
- Cisplatin plus paclitaxel improves OS
- Exploring the impact of therapy on survival
- Impact of 2nd-line treatment on OS
- 2nd-line liposomal doxorubicin vs. topotecan
- Impact of 3rd-line therapy on OS
- Evidence of the impact of subsequent therapy
- Impact of post-trial therapy on OS
- Surrogate endpoints and "personalized medicine"
- Acceptable randomized trial endpoints
- Additional issues in surrogate endpoints
- Conclusion
- Thank you
Topics Covered
- Improvement in overall survival must be considered the single most important goal of any new antineoplastic strategy
- Also increasingly recognized that in well-defined settings it is reasonable to employ other objectively measurable endpoints of efficacy such as time to symptomatic disease progression
- The rationale for the use of surrogate or alternative endpoints in cancer clinical trials
- Examples of where such endpoints may be appropriately utilized
Links
Series:
Categories:
Therapeutic Areas:
Talk Citation
Markman, M. (2018, September 30). Surrogate endpoints of efficacy [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 4, 2024, from https://doi.org/10.69645/OMIZ7043.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Maurie Markman has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Clinical Practice
Transcript
Please wait while the transcript is being prepared...
0:00
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.
0:21
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.
1:02
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.