Regulatory affairs in biotechnology: optimal statistical designs for biomedical experiments.

One of the major issues in all applications of biotechnology is how to regulate the process through which new technological information is produced. The end products of biotechnological applications are diverse (e.g., better drugs, better interventions, better fertilizers). Such applications should be properly regulated to obtain valid scientific findings in the most efficient way possible. Some statistically optimal designs are more popularly employed than others as regulatory tools in medical, pharmaceutical and clinical trials. The statistical and practical properties (strengths and weaknesses) are presented to better appreciate their optimality. Recent developments on some related issues are also reviewed.

[1]  Keumhee C. Carriere,et al.  Optimal Two-Period Crossover Designs: A Practical Solution , 1995 .

[2]  J. Grizzle THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. , 1965, Biometrics.

[3]  D. Vere Validity of cross-over trials [editorial] , 1979 .

[4]  A. Hedayat,et al.  Repeated Measurements Designs, II , 1978 .

[5]  P. Armitage,et al.  Autoregressive models in clinical trials , 1983 .

[6]  J. Fleiss,et al.  The two-period crossover design with baseline measurements , 1988 .

[7]  William G. Cochran,et al.  Experimental Designs, 2nd Edition , 1950 .

[8]  W. Federer,et al.  Two-Treatment Crossover Designs for Estimating a Variety of Effects , 1981 .

[9]  A. Willan,et al.  Carryover and the two-period crossover clinical trial. , 1986, Biometrics.

[10]  Lawrence E. Stivers,et al.  Testing for Equality of Means with Incomplete Data on One Variable: A Monte Carlo Study , 1975 .

[11]  J. N. S. Matthews,et al.  Recent Developments in Crossover Designs , 1988 .

[12]  H. I. Patel Use of baseline measurements in the two-period crossover design , 1983 .

[13]  G G Koch,et al.  A two-period crossover design for the comparison of two active treatments and placebo. , 1989, Statistics in medicine.

[14]  J. Fleiss,et al.  A critique of recent research on the two-treatment crossover design. , 1989, Controlled clinical trials.

[15]  William G. Cochran,et al.  Experimental designs, 2nd ed. , 1957 .

[16]  John Stufken,et al.  Some families of optimal and efficient repeated measurements designs , 1991 .

[17]  J. Fleiss,et al.  Adjusting for baseline measurements in the two-period crossover study: a cautionary note. , 1985, Controlled clinical trials.

[18]  D. V. Gokhale,et al.  A Survey of Statistical Design and Linear Models. , 1976 .

[19]  A. Azzalini,et al.  Some optimal designs for repeated measurements with autoregressive errors , 1987 .

[20]  Dibyen Majumdar,et al.  Optimal repeated measurements designs for comparing test treatments with a control , 1988 .

[21]  Joachim Kunert,et al.  Optimal Design and Refinement of the Linera Model with Applications to Repeated Measurements Designs , 1983 .

[22]  J. Kiefer Construction and optimality of generalized Youden designs II , 1975 .

[23]  D. Rubin,et al.  Statistical Analysis with Missing Data. , 1989 .

[24]  J. Matthews Optimal crossover designs for the comparison of two treatments in the presence of carryover effects and autocorrelated errors , 1987 .

[25]  A. S. Hedayat,et al.  Optimal Two-Period Repeated Measurements Designs , 1990 .

[26]  Fleiss Jl,et al.  On multiperiod crossover studies. , 1986 .

[27]  M. Hills,et al.  The two-period cross-over clinical trial. , 1979, British journal of clinical pharmacology.

[28]  Incomplete Repeated Measures Data Analysis in the Presence of Treatment Effects , 1994 .

[29]  Damaraju Raghavarao,et al.  Crossover designs for comparing treatments with a control , 1987 .

[30]  S. Wallenstein,et al.  The analysis of the two-period repeated measurements crossover design with application to clinical trials. , 1977, Biometrics.

[31]  Gregory C. Reinsel,et al.  Investigation of dual-balanced crossover designs for two treatments , 1992 .

[32]  Changbao Wu,et al.  Balanced Repeated Measurements Designs , 1980 .

[33]  Ebbutt Af Three-period crossover designs for two treatments. , 1984 .

[34]  J. Kunert Optimal repeated measurements designs for correlated observations and analysis by weighted least squares , 1985 .

[35]  R. Jennrich,et al.  Unbalanced repeated-measures models with structured covariance matrices. , 1986, Biometrics.

[36]  Franklin A. Graybill,et al.  Theory and Application of the Linear Model , 1976 .

[37]  A. Willan,et al.  Using the maximum test statistic in the two-period crossover clinical trial. , 1988, Biometrics.

[38]  P. S. Gill,et al.  Optimal change-over designs for correlated observations , 1987 .

[39]  G. Koch The use of non-parametric methods in the statistical analysis of a complex split plot experiment. , 1970, Biometrics.

[40]  H. I. Patel Analysis of incomplete data in a two-period crossover design with reference to clinical trials , 1985 .

[41]  E Laska,et al.  Optimal crossover designs in the presence of carryover effects. , 1983, Biometrics.

[42]  G G Koch,et al.  The use of non-parametric methods in the statistical analysis of the two-period change-over design. , 1972, Biometrics.

[43]  B. W. Brown The crossover experiment for clinical trials. , 1980, Biometrics.

[44]  J. Kunert Optimality of Balanced Uniform Repeated Measurements Designs , 1984 .

[45]  K C Carriere,et al.  Crossover designs for clinical trials. , 1994, Statistics in medicine.

[46]  T. Cleophas,et al.  FUNDAMENTAL ISSUES OF CHOOSING THE RIGHT TYPE OF TRIAL , 1994, American journal of therapeutics.

[47]  R. N. Curnow,et al.  The Desirability of Adjusting for Residual Effects in a Crossover Design , 1984 .

[48]  Gregory C. Reinsel,et al.  Optimal two-period repeated measurement designs with two or more treatments , 1993 .

[49]  Morris Meisner,et al.  A Variational Approach to Optimal Two-Treatment Crossover Designs: Application to Carryover-Effect Models , 1985 .

[50]  A P Grieve,et al.  A Bayesian analysis of the two-period crossover design for clinical trials. , 1985, Biometrics.

[51]  P. John Statistical Design and Analysis of Experiments , 1971 .