Statistical Modeling of Clinical Trials (Recruitment and Randomization)

References

• Anisimov , V. V. ( 2007 ). Effect of imbalance in using stratified block randomization in clinical trials. Bull. Int. Statist. Instit. LXII, Proc. 56 Ann. Sess. Lisbon, Portugal, pp. 5938–5941 .
   Google Scholar
• Anisimov , V. V. ( 2008 ). Using mixed Poisson models in patient recruitment in multicentre clinical trials . Proc. World Congr. Eng. II : 1046 – 1049 .
   Google Scholar
• Anisimov , V. V. ( 2009a ). Recruitment modeling and predicting in clinical trials . Pharm. Outsourc. 10 ( 1 ): 44 – 48 .
   Google Scholar
• Anisimov , V. V. ( 2009b ). Predictive modeling of recruitment and drug supply in multicenter clinical trials. Proc. Joint Statist. Meet. ASA, Washington, pp. 1248–1259 .
   Google Scholar
• Anisimov , V. ( 2010a ). Drug supply modeling in clinical trials (statistical methodology) . Pharm. Outsourc. May/June : 50 – 55 .
   Google Scholar
• Anisimov , V. ( 2010b ). Impact of stratified randomization in clinical trials . In: Giovagnoli , A. , Atkinson , A. C. , Torsney , B. , eds. MODA 9 – Advances in Model-Oriented Design and Analysis . Berlin : Physica-Verlag/Springer , pp. 1 – 8 .
   Google Scholar
• Anisimov , V. V. ( 2011 ). Effects of unstratified and center-stratified randomization in multicentre clinical trials . Pharm. Statist. 10 ( 1 ): 50 – 59 .
   PubMed Web of Science ®Google Scholar
• Anisimov , V. V. , Fedorov , V. V. (2006). Design of multicentre clinical trials with random enrolment. In: Balakrishnan , N. , Auget , J.-L. , Mesbah , M. , Molenberghs , G. , eds. Advances in Statistical Methods for the Health Sciences . Ch. 25. Birkhäuser, pp. 393–406.
   Google Scholar
• Anisimov , V. V. , Fedorov , V. V. ( 2007 ). Modeling, prediction and adaptive adjustment of recruitment in multicentre trials . Statist. Med. 26 ( 27 ): 4958 – 4975 .
   PubMed Web of Science ®Google Scholar
• Anisimov , V. , Fedorov , V. , Heiberger , R. , Saha , S. , Kothapalli , M. ( 2010 ). Drug supply modeling software. User Manual. Collegeville, PA: GSK DDS TR 2010-01 .
   Google Scholar
• Bates , G. E. , Neyman , J. ( 1952 ). Contributions to the theory of accident proneness . Univ. Calif. Public. Statist. 1 ( 9 ): 215 – 254 .
   Google Scholar
• Carter , R. E. , Sonne , S. C. , Brady , K. T. ( 2005 ). Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study . BMC Med. Res. Methodol. 5 : 11 .
   PubMedGoogle Scholar
• Hallstrom , A. , Davis , K. ( 1988 ). Imbalance in treatment assignments in stratified blocked randomization . Controll. Clin. Trials 9 : 375 – 382 .
   PubMedGoogle Scholar
• Johnson , N. L. , Kotz , S. , Kemp , A. W. ( 1993 ). Univariate Discrete Distributions. , 2nd ed. New York : John Wiley & Sons .
   Google Scholar
• Johnson , N. L. , Kotz , S. , Balakrishnan , N. ( 1994 ). Continuous Univariate Distributions. , 2nd ed. Vol. 1 . New York : John Wiley & Sons .
   Google Scholar
• Rosenberger , W. F. , Lachin , J. M. ( 2002 ). Randomization in Clinical Trials . New York : John Wiley & Sons .
   Google Scholar
• Senn , S. ( 1997 ). Statistical Issues in Drug Development . Chichester : John Wiley & Sons .
   Google Scholar
• Senn , S. ( 1998 ). Some controversies in planning and analysis multi-center trials . Statist. Med. 17 : 1753 – 1756 .
   PubMed Web of Science ®Google Scholar