Open Conference Systems, 50th Scientific meeting of the Italian Statistical Society

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A simulation study on the use of response-adaptive randomized designs
Anna Maria Paganoni, Andrea Ghiglietti, Maria Giovanna Scarale, Rosalba Miceli, Francesca Ieva, Luigi Mariani, Cecilia Gavazzi, Valeria Edefonti

Last modified: 2018-05-10

Abstract


Response-adaptive designs have been proposed in randomized clinical trials to achieve ethical advantages by using sequential accrual information collected during the trial to update probabilities of treatment assignments. We propose the use of a response adaptive design based on urn models in a simulation study on a randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the adaptive design with those previously obtained with the non-adaptive approach.

References


Atkinson, A.C., Biswas, A., 2014.
Randomised response-adaptive designs in clinical trials.
Chapman and Hall/CRC.

Durham, S.C., Flournoy, N. and  Li, W., 1998.
A sequential design for maximizing the probability of a response. The Canad. J. Stat., 26 (3), 479-495.

Gavazzi, C., Colatruglio, S., Valoriani, F., Mazzaferro, V.,
Sabbatini, A., Biffi, R., Mariani, L., Miceli, R. 2016.
Impact of home enteral nutrition in malnourished patients with upper gastrointestinal cancer: a multicenter randomized clinical trial.
Europ. J. Cancer, 64, 107-112.

Ghiglietti, A., Scarale, M.G., Miceli, R.,  Ieva, F., Mariani, L., Gavazzi, C., Paganoni, A.M., Edefonti, V. 2018. Urn models for response-adaptive randomized designs:
a simulation study based on a non-adaptive randomized trial J Biopharm Stat, In press.

Muliere, P., Paganoni, A.M., Secchi, P., 2006.
A randomly reinforced urn. J. Stat. Plann. Inference, 136, 1853-1874.

Wei, L.J. 1978.
An application of an urn model to the design of sequential controlled clinical trials.
JASA, 73, 559-563.


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