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Performances of Poisson–Gamma Model for Patients’ Recruitment in Clinical Trials When There Are Pauses in Recruitment or When the Number of Centres is Small

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Statistics and Simulation (IWS 2015)

Part of the book series: Springer Proceedings in Mathematics & Statistics ((PROMS,volume 231))

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Abstract

To predict the duration of a clinical trial is a question of paramount interest. To date, the more elaborated model is the so-called Poisson–gamma model introduced by Anisimov and Fedorov in 2007. Theoretical performances of this model are asymptotic and have been established under assumptions especially on the recruitment rates by centre which are assumed to be constant in time. In order to evaluate the practical use of this model, ranges of validity have to be assessed. By means of simulation studies, authors investigate, on the one hand, the impact of the number of centres involved, of the average recruitment rate, of the duration of recruitment and of the interim time of analysis on the expected duration of the trial and, on the other hand, two strategies of estimation of the trial duration accounting for breaks in recruitment (period during which centres do not recruit) which are compared and discussed. These investigations yield to guidelines on the use of Poisson–gamma processes to model recruitment dynamics regarding these issues.

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Acknowledgements

This research has received the help from IRESP during the call for proposals launched in 2012 as a part of French “Cancer Plan 2009–2013”.

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Authors and Affiliations

  1. INSERM UMR 1027, University of Toulouse III, 31073, Toulouse, France

    Nathan Minois, Stéphanie Savy & Sandrine Andrieu

  2. University of Paris XI, 91405, Orsay, France

    Guillaume Mijoule

  3. Epidemiology Unit, CHU Purpan, 31062, Toulouse, France

    Valérie Lauwers-Cances

  4. Epidemiology Unit of Toulouse CHU, 31073, Toulouse, France

    Sandrine Andrieu

  5. Toulouse Institute of Mathematics, University of Toulouse III, 31062, Toulouse, France

    Nicolas Savy

Authors
  1. Nathan Minois
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  2. Guillaume Mijoule
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  3. Stéphanie Savy
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  4. Valérie Lauwers-Cances
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  5. Sandrine Andrieu
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  6. Nicolas Savy
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Corresponding author

Correspondence to Nicolas Savy .

Editor information

Editors and Affiliations

  1. Institute of Statistics, Alpen-Adria University of Klagenfurt, Klagenfurt, Austria

    Jürgen Pilz

  2. Institute of Applied Statistics and Computing, University of Natural Resources and Life Sciences, Vienna, Austria

    Dieter Rasch

  3. St. Petersburg State University, St. Petersburg, Russia

    Viatcheslav B. Melas

  4. Institute of Applied Statistics and Computing, University of Natural Resources and Life Sciences, Vienna, Austria

    Karl Moder

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Minois, N., Mijoule, G., Savy, S., Lauwers-Cances, V., Andrieu, S., Savy, N. (2018). Performances of Poisson–Gamma Model for Patients’ Recruitment in Clinical Trials When There Are Pauses in Recruitment or When the Number of Centres is Small. In: Pilz, J., Rasch, D., Melas, V., Moder, K. (eds) Statistics and Simulation. IWS 2015. Springer Proceedings in Mathematics & Statistics, vol 231. Springer, Cham. https://doi.org/10.1007/978-3-319-76035-3_20

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