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Printable Handouts
Navigable Slide Index
- Introduction
- Outline
- Definition of an adaptive clinical trial
- FDA: guidance for industrial adaptive design
- Type of the adaptive trials
- Three major types of trials
- Three types of clinical endpoints
- Two types of adaptive design
- Biomarker-adaptive clinical trials design
- Recently FDA approved drugs (1)
- Recently FDA approved drugs (2)
- Recently FDA approved drugs (3)
- Prognostic marker
- Predictive marker
- Enrichment designs
- Biomarker-stratified design (1)
- Biomarker-stratified design (2)
- Randomized hybrid design
- Umbrella and basket trials
- Examples of phase I, II, and III trials
- Phase I: CRM (1)
- Phase I: CRM (2)
- Schematic of CRM phase I trial
- Adaptive randomization phase II designs (1)
- Adaptive randomization phase II designs (2)
- Adaptive randomization phase II designs (3)
- Adaptive randomization phase II designs: summary
- Umbrella trial example
- Future directions
- Thanks for listening
Topics Covered
- Definition of an adaptive clinical trial
- Three major types of trials
- Three types of clinical endpoints
- Biomarker-adaptive clinical trials design
- Recently FDA approved drugs
- Prognostic marker
- Predictive marker
- Enrichment designs
- Biomarker-stratified design
- Randomized hybrid design
- Umbrella and basket trials
- Examples of phase I, II, and III trials
Talk Citation
Shyr, Y. (2017, August 31). Adaptive clinical trials: conclusion and future directions [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved December 7, 2024, from https://doi.org/10.69645/PYFU2183.Export Citation (RIS)
Publication History
Financial Disclosures
- Professor Yu Shyr has no commercial/financial relationships to disclose
Other Talks in the Series: Adaptive Clinical Trial Design
Transcript
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0:00
Welcome to the last lecture of the "Adaptive Clinical Trials" course.
In this last lecture,
we will talk about the conclusion and the future directions of the adaptive clinical trials.
My name is Yu Shyr,
I'm the director of the Vanderbilt Center for Quantitative Sciences.
0:25
In today's lecture, we will discuss several topics.
Again, I will start to review the definition of adaptive clinical trial.
You have been in this course for a while,
to the several different lectures.
I hope you enjoyed that.
And in the last lecture review,
what is the definition of an adaptive clinical trial.
Then we will talk about the type of adaptive trials,
then we will talk about biomarker-adaptive clinical trials design.
If you took my first lecture which is overview,
if you still remember what I said,
I said we will come back, in the very last lecture, to talk more about
biomarker adaptive clinical trial design because we are going to see
more and more talkative therapy using biomarker-based to study.
So today, in this very last lecture, before I finish all this entire course series,
I would like to give you some idea about
the in-depth discussion about biomarker-adaptive clinical trial design.
Then I will give you several examples of phase I,
II and III adaptive trial design.
That's kind of the end of this entire course series and I would end with the last slide;
talk about what I feel,
what I think about the future direction of the adaptive clinical trials design.
So this is the highlight of your last lecture.