Download - Clinical Trial Design
![Page 1: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/1.jpg)
1
به نام ايزد يکتا
Clinical Trial Design
Dr. Khalili
The common types Advantages and limitations Usual applications
![Page 2: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/2.jpg)
Dr. Khalili 2
Clinical Trial (on patients)vs.
Field Trial (on healthy people)
Community Trial (on communities)
![Page 3: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/3.jpg)
Dr. Khalili 3
![Page 4: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/4.jpg)
Dr. Khalili 4
AfterBefore Intervention
In phase II clinical trials OR in serious diseases such as cancers
![Page 5: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/5.jpg)
Dr. Khalili 5
![Page 6: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/6.jpg)
Dr. Khalili 6
![Page 7: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/7.jpg)
Dr. Khalili 7
![Page 8: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/8.jpg)
Dr. Khalili 8
![Page 9: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/9.jpg)
Dr. Khalili 9
![Page 10: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/10.jpg)
Dr. Khalili 10
![Page 11: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/11.jpg)
Dr. Khalili 11
![Page 12: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/12.jpg)
Dr. Khalili 12
Notice: the standard methods for sample size calculation and data analysis considering subject as analysis unit are not appropriate here.
![Page 13: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/13.jpg)
Dr. Khalili 13
Be relax forfew minutes
![Page 14: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/14.jpg)
Dr. Khalili 14
![Page 15: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/15.jpg)
Dr. Khalili 15
• Advantages:
Allows within-patients comparisons of treatments
Removes interpatient variabilityProvides the best unbiased estimates for
the differences between treatmentsDecreases number of patients needed
![Page 16: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/16.jpg)
Dr. Khalili 16
• Limitations:• It is applicable where:
Objective measures for efficacy and safety are obtained Chronic and relatively stable disease Prophylactic drugs with relatively short half life Relatively short treatment periods Baseline and washout periods are feasible
• It increases the duration of the study• Its analysis is not straightforward:
The paired design The period and carry-over effects
• The effect of loss to follow-up
![Page 17: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/17.jpg)
Dr. Khalili 17
• Sequence (Period) Effect: The order in which the therapies are given may
elicit psychological responses. Patients may react differently to the first
therapy given in a study as a result of the enthusiasm may diminish over
time.
• Carryover Effect: If a subject is changed from therapy A to therapy B and
observed under each therapy, the observations under therapy B will be
valid only if there is no residual carryover from therapy A. There must be
enough of a washout period to be sure none of therapy A or its effect
remains.
![Page 18: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/18.jpg)
Dr. Khalili 18
![Page 19: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/19.jpg)
Dr. Khalili 19
To resolve the problom:
![Page 20: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/20.jpg)
Two applications:1. Quantifying the interaction between the
two treatments2. Opportunistic situations
![Page 21: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/21.jpg)
Dr. Khalili 21
A Full (a+1) * (b+1) Factorial Design for Combination Therapy of Two Components at a and b Dose Levels
![Page 22: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/22.jpg)
Dr. Khalili 22
Designs with ethical considerations
• Adaptive Randomization
• Zelen design
• Variations of placebo-controlled trials:
• Add-on design
• Replacement design
• Randomized Withdrawal design
• Sequential analysis
![Page 23: Clinical Trial Design](https://reader036.vdocuments.us/reader036/viewer/2022062315/5681614f550346895dd0d51a/html5/thumbnails/23.jpg)
Dr. Khalili 23
And more complex DESIGNS …