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.
- View the Talks
-
1. Adaptive clinical trials: overview 1
- Prof. Yu Shyr
-
2. Adaptive clinical trials: overview 2
- Prof. Yu Shyr
-
3. Bayesian adaptive designs for clinical trials
- Prof. Benjamin Saville
-
4. Adaptive clinical trial design: randomization
- Prof. Hao Liu
-
5. Adaptive designs for phase I trials 1
- Prof. Anastasia Ivanova
-
6. Adaptive designs for phase I trials 2
- Prof. Anastasia Ivanova
-
7. Case studies of adaptive early phase trials
- Prof. Daniel Normolle
-
8. Phase II clinical trials - traditional approaches
- Prof. Fei Ye
-
9. Phase II clinical trials - Bayesian methods
- Prof. Fei Ye
-
10. Seamless phase II/III trials
- Prof. Elizabeth Garrett-Mayer
- Mr. Nathaniel O’Connell
-
11. Frequentist approaches: sample size in adaptive clinical designs
- Prof. Tatsuki Koyama
-
14. Ethical issues in adaptive clinical trials
- Dr. Spencer Phillips Hey
-
15. Implementation of adaptive methods in early phase clinical trials
- Prof. Gina Petroni
-
16. Design early phase drug combination trials: methods
- Prof. Ying Yuan
-
17. Design early phase drug combination trials: software
- Prof. Ying Yuan
-
18. Adaptation in likelihood trials
- Prof. Jeffrey Blume
Printable Handouts
Navigable Slide Index
- Introduction
- Dose-toxicity relationship
- Dose-finding with toxicity endpoint
- Why do we need to find the MTD?
- How to find the MTD?
- Potential shortcomings of the parallel design
- Potential shortcomings of the escalation design
- Traditional or 3+3 design (1)
- Traditional or 3+3 design (2)
- Example of the 3+3 design
- 3+3 design: operating characteristics
- 3+3 design: operating characteristics (example)
- 3+3 design: advantages and disadvantages
- 5+5 design
- 3+3 may result in a very long trial
- Review of dose-finding designs
- Features of up-and-down designs
- Up-and-down design of Dixon and Mood
- Up-and-down designs (example)
- Up-and-down experiments
- Group up-and-down designs (1)
- Group up-and-down designs (example 1)
- Group up-and-down designs (example 2)
- The t-statistic design
- Illustrating the t-statistic design
Topics Covered
- Dose finding designs
- 3+3 design
- Group up-and-down designs
- The t-statistic design
Links
Series:
Categories:
Talk Citation
Ivanova, A. (2016, September 29). Adaptive designs for phase I trials 1 [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 12, 2024, from https://doi.org/10.69645/NXSR1463.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Anastasia Ivanova has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Adaptive designs for phase I trials 1
Published on September 29, 2016
31 min
A selection of talks on Methods
Transcript
Please wait while the transcript is being prepared...
0:00
Hi, my name is Anastasia Ivanova
from the Department of Biostatistics,
University of North Carolina
at Chapel Hill.
And today, we're gonna talk
about Adaptive Designs
for Phase I Trials.
These designs were developed
and are used in Phase I trials
in oncology.
Some of these designs
can be used in Phase I
and mostly Phase II trials
in areas other than oncology.
Since these designs
are mostly used in oncology,
I will focus
on oncology applications
throughout this lecture.
0:36
In oncology, we usually consider
several fixed doses
from three to eight.
And we assume
that the probability of toxicity
is non-decreasing with the dose.
Here, on this plot, I have a curve
showing the probability of toxicity
as a function of dose.
The goal of a Phase I trial
in oncology
is usually to find
the Maximum Tolerated Dose or MTD.
The MTD is defined as a dose
with a certain probability
of toxicity, usually 20%.
In oncology, the primary outcome
in dose-finding studies
is actually the Dose Limiting Toxicity,
but I will use these two terms
interchangeably DLT or toxicity.
1:29
So as I said,
the Maximum Tolerated Dose
is defined as the dose
where the probability of toxicity
is equal to a certain number
but you know this number as Γ.
And Γ is usually 20%
in Phase I trials in oncology.