Integrating Clinical Research into Epidemic Response The Ebola Experience (2017) / Chapter Skim
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Appendix B: Clinical Trial Designs
Appendix B: Clinical Trial Designs
Pages 287-296
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From page 287... ...
Glasziou et two or more that is unbiased • Sample sizes can also be al., 2007; treatments (e.g., and consistent. large when the desired Suresh, active treatment effect size to detect is 2011)
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• After randomization, individuals in the clusters may be approached for consent, which raises the possibility of post randomization selection bias, or they may not, which raises ethical concerns.
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• For evaluating the • Imposes some practical • The order effectiveness of implementation in which interventions that challenges, such the different have been shown as preventing individuals or to be efficacious contamination between clusters receive in a more limited, intervention participants the intervention research setting and those waiting for is determined at and are now being the intervention and random, and, scaled up to the ensuring that those by the end of community level. assessing outcomes are the random • This design blind to the participants' allocation, all is also useful statuses as intervention individuals or for evaluating or control in order groups will have temporal changes to help guard against received the in the intervention information bias.
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290 INTEGRATING CLINICAL RESEARCH INTO EPIDEMIC RESPONSE TABLE B-1 Continued Design Structure Advantages Disadvantages 2. There may be logistical, practical, or financial constraints that mean the intervention can only be implemented in stages.
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From page 291... ...
be introduced • Need to ensure that no from making bias in the evaluation is comparisons introduced in multi between center multiarm studies treatments tested through imbalances in separate trials; between allocations to 3. he use of T treatments at different interim analyses centers/regions.
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study may encounter All participants enrollment issues; it eventually receive needs to recruit patients the potentially who are willing to be beneficial medical off the symptomatic intervention, while therapy for the first a control group is half of the study if they maintained in the are randomized to the initial phase. control arm.
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development by o Technical concerns • Adaptive enabling real- o Perceptions of platform designs time learning and regulatory risk offer flexible terminating a trial o Challenges related to features such or treatment arms change management as dropping at the earliest time treatments for point, enabling futility, declaring the choice of the one or more correct dose(s) treatments for Phase III, superior, or and by enabling adding new the selection of treatments to be the population tested during the responding best to course of a trial.
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. • Best used when the natural history of the disease is well understood, when placebo effects are minimal or nonexistent, and when a placebo control is not ethically desirable.
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2011) Reports of case • Easy and • Cannot easily examine series usually inexpensive to disease etiology.
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2011. An overview of randomization techniques: An unbiased assessment of outcome in clinical research.
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