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A Bayesian response-adaptive dose finding and comparative effectiveness trial | | Anna Heath
; Maryna Yaskina
; Petros Pechlivanoglou
; Juan David Rios
; Martin Offringa
; Terry P Klassen
; Naveen Poonai
; Eleanor Pullenayegum
; | | Date: |
11 Jun 2020 | | Abstract: | Aims: Combinations of treatments can offer additional benefit over the
treatments individually. However, trials of these combinations are lower
priority than the development of novel therapies, which can restrict funding,
timelines and patient availability. Thus, this paper develops a novel trial
design to facilitate the evaluation of novel combination therapies. This design
combines elements of phase II and phase III trials to reduce the administrative
burden of undertaking these trials. Methods: This trial uses response adaptive
randomisation to increase the information collected about successful novel drug
combinations and Bayesian dose-response modelling to undertake a
comparative-effectiveness analysis for the most successful dose combination
against a relevant comparator. We used simulation methods to evaluate the
probability of selecting the correct optimal dose combination and the
frequentist and Bayesian operating characteristics of this design for a trial
in pain management and sedation in pediatric emergency departments. We also
compared the design to a standard frequentist trial. Results: With 410
participants and 5 interim updates of the randomisation ratio, we have an 83%
chance of selecting the correct optimal treatment. The comparative
effectiveness analysis has a the type I error of the trial of less than 5% and
a power greater than 94%, for expected values of effectiveness for the
combination therapy. The trial offers an increase in power for all scenarios,
compared to a trial with equal randomisation and the predictive power of the
trial is over 90%. Conclusion: By simultaneously determining the optimal dose
and collecting data on the relative effectiveness of an intervention, we can
minimise administrative burden and recruitment time for a trial. The proposed
trial has high potential to meet the dual study objectives within a feasible
level of recruitment. | | Source: | arXiv, 2006.6739 | | Services: | Forum | Review | PDF | Favorites | |
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