Global Forum on Bioethics in Research Emerging Epidemic Infections and Experimental Treatments November 4 2015 Lord Kelvin I often say that when you can measure what you are speaking about and express it in numbers you know something about it but when you cannot measure it when you canno ID: 490210
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Slide1
Adaptive Trial Designs
Global Forum on Bioethics in Research
:
Emerging Epidemic Infections and Experimental Treatments
November 4, 2015Slide2Slide3Slide4
Lord Kelvin
I often say that when you can measure what you are speaking about and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind; it may be the beginning of knowledge, but you have scarcely in your thoughts advanced to the state of Science, whatever the matter may be.Slide5
Nietzsche
Against that positivism which stops before the phenomena, saying “there are only facts” I should say: no, it is precisely facts that do not exists, only
interpretations…Slide6
Truth
The truth cannot be told so as to be understood but not believed.
William BlakeSlide7
Randomized Control
Trial
Time
Sample
Of
Persons
Inception Cohort
Random
Allocation
Treatment
Measure
outcomes
Sampling is done here
ControlSlide8
Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease
In
this context, an adaptive trial design that has the capacity to yield meaningful and interpretable data quickly in the midst of the (Ebola) epidemic might be considered as preferable. An adaptive design could include elements of randomized controlled trials, cluster randomization, stepped wedge, and single arm comparison trials. Adaptive trial designs are more complex to coordinate among sites.Slide9Slide10Slide11Slide12Slide13
Cartwright’s Causal Criterion
C causes E if and only if P (E/C) +/- {F
1
+ F2…FN
} > P(E/-C} +/- { F
1
+ F
2
…F
N
} where F
1
…F
N are a complete set of covariatesAn idealized model that sets out precise ceteris paribus conditions