Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials
ABSTRACT
Current minimization programs do not permit full control over different aspects of minimization algorithm such as distance or probability measures and may not allow for unequal allocation ratios. This article describes the implementation of “MinimPy” an open-source minimization program in Python programming language, which provides full customizetion of minimization features. MinimPy supports naive and biased coin minimization together with various new and classic distance measures. Data syncing is provided to facilitate minimization of multicenter trial over the network. MinimPy can easily be modified to fit special needs of clinical trials and in particular change it to a pure web application, though it currently supports network syncing of data in multi-center trials using network repositories.
Current minimization programs do not permit full control over different aspects of minimization algorithm such as distance or probability measures and may not allow for unequal allocation ratios. This article describes the implementation of “MinimPy” an open-source minimization program in Python programming language, which provides full customizetion of minimization features. MinimPy supports naive and biased coin minimization together with various new and classic distance measures. Data syncing is provided to facilitate minimization of multicenter trial over the network. MinimPy can easily be modified to fit special needs of clinical trials and in particular change it to a pure web application, though it currently supports network syncing of data in multi-center trials using network repositories.
Cite this paper
nullSaghaei, M. and Saghaei, S. (2011) Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. Journal of Biomedical Science and Engineering, 4, 734-739. doi: 10.4236/jbise.2011.411090.
nullSaghaei, M. and Saghaei, S. (2011) Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. Journal of Biomedical Science and Engineering, 4, 734-739. doi: 10.4236/jbise.2011.411090.
References
[1] Schulz, K.F., Altman, D.G. and Moher, D. (2010) CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine, 152, 1-8. [2] Directory of randomization software and service, 2011. http://www-users.york.ac.uk/~mb55/guide/randsery.htm. [3] Lachin, J.M. (1988) Statistical properties of randomization in clinical trials. Controlled Clinical Trials, 9, 289- 311. doi:10.1016/0197-2456(88)90045-1 [4] Kernan, W.N., Viscoli, C.M., Makuch, R.W., Brass, L.M. and Horwitz, R.I. (1999) Stratified randomization for clinical trials. Journal of Clinical Epidemiology, 52, 19- 26. doi:10.1016/S0895-4356(98)00138-3 [5] Taves, D.R. (1974) Minimization: A new method of assigning patients to treatment and control groups. Clinical Pharmacology & Therapeutics, 15, 443-453. [6] Pocock, S.J. and Simon, R. (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics, 31, 103-115. doi:10.2307/2529712 [7] Scott, N.W., McPherson, G.C., Ramsay, C.R., Campbell MK. (2002) The method of minimization for allocation to clinical trials: A review. Controlled Clinical Trials, 23, 662-674. doi:10.1016/S0197-2456(02)00242-8 [8] McEntegart, D.J. (2003) The pursuit of balance using stratified and dynamic randomization techniques: An overview. Drug Information Journal, 37, 293-308. [9] Halpern, J. and Brown, B.W. Jr. (1986) Sequential treatment allocation procedures in clinical trials with particular attention to the analysis of results for the biased coin design. Statistics in Medicine, 5, 211-229. doi:10.1002/sim.4780050303 [10] Lachin, J.M., Matts, J.P. and Wei, L.J. (1988) Randomization in clinical trials: Conclusions and recommendations. Controlled Clinical Trials, 9, 365-374. doi:10.1016/0197-2456(88)90049-9 [11] Minim: Allocation by minimisation in clinical trials, 2004. http://www-users.york.ac.uk/~mb55/guide/minim.htm. [12] Cai, H.W., Xia, J.L., Gao, D.H. and Cao, X.M. (2010) Implementation and experience of a web-based allocation system with Pocock and Simon’s minimization methods. Contemporary Clinical Trials, Vol. 31, No. 6, 2010, pp. 510-513. doi:10.1016/j.cct.2010.07.009 [13] Han, B., Enas, N.H., McEntegart, D.J. (2009) Randomization by minimization for unbalanced treatment allocation. Statistics in Medicine, 28, 3329-3346. doi:10.1002/sim.3710 [14] Python Programming Language Official Website, 2011. http://www.python.org/. [15] Matsumoto, M., Nishimura, T. (1998) Mersenne twister: A 623-dimensionally equidistributed uniform pseudorandom number generator. ACM Transactions on Modeling and Computer Simulation, 8, 3-30. doi:10.1145/272991.272995 [16] Subversion.tigris.org, 2011. http://subversion.tigris.org/ [17] Pysvn.tigris.org, 2011. http://pysvn.tigris.org/
[1] Schulz, K.F., Altman, D.G. and Moher, D. (2010) CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials. Annals of Internal Medicine, 152, 1-8. [2] Directory of randomization software and service, 2011. http://www-users.york.ac.uk/~mb55/guide/randsery.htm. [3] Lachin, J.M. (1988) Statistical properties of randomization in clinical trials. Controlled Clinical Trials, 9, 289- 311. doi:10.1016/0197-2456(88)90045-1 [4] Kernan, W.N., Viscoli, C.M., Makuch, R.W., Brass, L.M. and Horwitz, R.I. (1999) Stratified randomization for clinical trials. Journal of Clinical Epidemiology, 52, 19- 26. doi:10.1016/S0895-4356(98)00138-3 [5] Taves, D.R. (1974) Minimization: A new method of assigning patients to treatment and control groups. Clinical Pharmacology & Therapeutics, 15, 443-453. [6] Pocock, S.J. and Simon, R. (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics, 31, 103-115. doi:10.2307/2529712 [7] Scott, N.W., McPherson, G.C., Ramsay, C.R., Campbell MK. (2002) The method of minimization for allocation to clinical trials: A review. Controlled Clinical Trials, 23, 662-674. doi:10.1016/S0197-2456(02)00242-8 [8] McEntegart, D.J. (2003) The pursuit of balance using stratified and dynamic randomization techniques: An overview. Drug Information Journal, 37, 293-308. [9] Halpern, J. and Brown, B.W. Jr. (1986) Sequential treatment allocation procedures in clinical trials with particular attention to the analysis of results for the biased coin design. Statistics in Medicine, 5, 211-229. doi:10.1002/sim.4780050303 [10] Lachin, J.M., Matts, J.P. and Wei, L.J. (1988) Randomization in clinical trials: Conclusions and recommendations. Controlled Clinical Trials, 9, 365-374. doi:10.1016/0197-2456(88)90049-9 [11] Minim: Allocation by minimisation in clinical trials, 2004. http://www-users.york.ac.uk/~mb55/guide/minim.htm. [12] Cai, H.W., Xia, J.L., Gao, D.H. and Cao, X.M. (2010) Implementation and experience of a web-based allocation system with Pocock and Simon’s minimization methods. Contemporary Clinical Trials, Vol. 31, No. 6, 2010, pp. 510-513. doi:10.1016/j.cct.2010.07.009 [13] Han, B., Enas, N.H., McEntegart, D.J. (2009) Randomization by minimization for unbalanced treatment allocation. Statistics in Medicine, 28, 3329-3346. doi:10.1002/sim.3710 [14] Python Programming Language Official Website, 2011. http://www.python.org/. [15] Matsumoto, M., Nishimura, T. (1998) Mersenne twister: A 623-dimensionally equidistributed uniform pseudorandom number generator. ACM Transactions on Modeling and Computer Simulation, 8, 3-30. doi:10.1145/272991.272995 [16] Subversion.tigris.org, 2011. http://subversion.tigris.org/ [17] Pysvn.tigris.org, 2011. http://pysvn.tigris.org/