Adaptive Trial Designs Global Forum on Bioethics
Description: Adaptive Trial Designs 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,
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slide1. Adaptive Trial Designs Global Forum on Bioethics in Research:
Emerging Epidemic Infections and Experimental Treatments
November 4, 2015<br>
slide4. 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.<br>
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…<br>
slide6. Truth The truth cannot be told so as to be understood but not believed.
William Blake<br>
slide7. Randomized Control Trial Time Sample
Of
Persons Inception Cohort Random
Allocation Treatment Measure
outcomes Sampling is done here Control<br>
slide8. 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.<br>
slide13. Cartwright’s Causal Criterion C causes E if and only if P (E/C) +/- {F1 + F2…FN} > P(E/-C} +/- { F1+ F2…FN} where F1…FN are a complete set of covariates
An idealized model that sets out precise ceteris paribus conditions<br>
Emerging Epidemic Infections and Experimental Treatments
November 4, 2015<br>
slide4. 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.<br>
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…<br>
slide6. Truth The truth cannot be told so as to be understood but not believed.
William Blake<br>
slide7. Randomized Control Trial Time Sample
Of
Persons Inception Cohort Random
Allocation Treatment Measure
outcomes Sampling is done here Control<br>
slide8. 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.<br>
slide13. Cartwright’s Causal Criterion C causes E if and only if P (E/C) +/- {F1 + F2…FN} > P(E/-C} +/- { F1+ F2…FN} where F1…FN are a complete set of covariates
An idealized model that sets out precise ceteris paribus conditions<br>