Classification of the effectiveness of combination treatments

Statistics in Medicine

Volumn 16, Issue 19, 1997, Pages 2211-2228

  Laska, Eugene M ^a,b   Meisner, Morris ^a,b   Tang, Dei In ^a  

^a NATHAN S KLINE INSTITUTE FOR PSYCHIATRIC RESEARCH   (United States)

^b NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLASSIFICATION; COMBINATION CHEMOTHERAPY; DRUG ANTAGONISM; DRUG POTENTIATION; STATISTICAL ANALYSIS;

ANIMALS; ANTIDEPRESSIVE AGENTS; ANTIPSYCHOTIC AGENTS; DEPRESSIVE DISORDER; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ANTAGONISM; DRUG COMBINATIONS; DRUG SYNERGISM; DRUG THERAPY, COMBINATION; HUMANS; RANDOMIZED CONTROLLED TRIALS; SCHIZOPHRENIA; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030979679     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0258(19971015)16:19<2211::AID-SIM657>3.0.CO;2-3     Document Type: Article

References (53)

1. Ash, C. W. and Brown R. H. 'Significance levels for use in the analysis of combination drug trials', Communications in Statistics, A20, 3283-3292 (1991).
2. Gibson, J. M. and Overall, J. E. 'The superiority of a drug combination over each of its components', Statistics in Medicine, 8, 1479-1484 (1989).
3. Hung, H. M. J., Ng, T. H., Chi, G. Y. H. and Lipicky, R. J. 'Response surface and factorial designs for combination antihypertensive drugs', Drug Information Journal, 2, 371-378 (1990).
4. Hung, H. M. J., Chi, G. Y. H. and Lipicky, R. J. 'Testing for the existence of a desirable dose combination', Biometrics, 49, 85-94 (1993).
5. Hung, H. M. J., Chi, G. Y. H. and Lipicky, R. J. 'On some statistical methods for analysis of combination drug studies', Communications in Statistics, Theory and Methods, A23, 361-376 (1994).
6. Hung, H. M. J. 'Global tests for combination drug studies in factorial trials', Statistics in Medicine, 15, 233-248 (1996).
7. Laska, E. M. and Meisner, M. J. 'Testing whether an identified treatment is best', Biometrics, 45, 1139-1151 (1989).
8. Laska, E. M., Tang, D. I. and Meisner, M. 'Testing hypotheses about an identified treatment when there are multiple endpoints', Journal of the American Statistical Association, 87, 825-831 (1992).
9. Leung, H. M. and O'Neill, R. 'Statistical assessment of combination drugs: A regulatory view', Proceedings of the Biopharmaceutical Section of the American Statistical Association, 33-36 (1986).
10. Patel, H. I. 'Comparison of treatments in a combination drug trial', Journal of Biopharmaceutical Statistics, 1, 171-183 (1991).
11. Patel, H. I. 'Dose-response in pharmacokinetics', Communications in Statistics, Part A: Theory and Methods, 23, 451-465 (1994).
12. Phillips, J. A., Cairns, V. and Koch, G. G. 'The analysis of a multiple-dose, combination-drug clinical trial using response surface methodology', Journal of Biopharmaceutical Statistics, 2, 49-67 (1992).
13. Sarkar, S. K., Snappinn, S. and Wang, W. 'On improving the Min test for the analysis of combination drug trials', Proceedings of the Biopharmaceutical Section of the American Statistical Association, 212-217 (1993).
14. Snappinn, S. M. 'Evaluating the efficacy of a combination therapy', Statistics in Medicine, 6, 657-665 (1987).
15. Snappinn, S. M. and Sarkar, S. K. 'A note on assessing the superiority of a combination drug with a specific alternative', Proceedings of the Biopharmaceutical Section of the American Statistical Association, 20-25 (1995).
16. Stablein, D. M., Novak, J. V. V., Peace, K. E., Laska, E. M. and Meisner, M. 'Optimization in clinical trials and combination drug development', in Peace, K. E. (ed.), Statistical Issues in Drug Research and Development, Marcel Dekker, Inc., New York, 1990, pp. 263-303.
17. Wang, S.-J. and Hung, H. M. J. 'On some large sample tests for binary outcome in fixed dose combination drug studies', Proceedings of the Biopharmaceutical Section of the American Statistical Association, 36-41 (1995).
18. Berenbaum, M. C. 'Synergy additivity and antagonism in immuno-suppression: A critical review', Clinical and Experimental Immunology, 28, 1-18 (1977).
19. Berenbaum, M. C. 'The expected effect of a combination of agents: The general solution', Journal of Theoretical Biology, 114, 413-431 (1985).
20. Berenbaum, M. C. 'Isobolic, algebraic, and search methods in the analysis of multiagent synergy', Journal of the American College of Toxicology, 7, 927-938 (1988).
21. Berenbaum, M. C. 'What is synergy?', Pharmacological Reviews, 41, 93-141 (1989).
22. Bliss, C. I. 'The toxicity of poisons applied jointly', Annals of Applied Biology, 26, 585-615 (1939).
23. Carter, W. H. Jr., Wampler, G. L., Stablein, D. M. and Campbell, E. D. 'Drug activity and therapeutic synergism in cancer treatment', Cancer Research, 42, 2963-2971 (1982).
24. Carter, W. H. Jr. 'Response surface methodology and the design of clinical trials for the evaluation of cancer chemotherapy', Cancer Treatment Reports, 69, 1049-1051 (1985).
25. Carter, W. H. Jr., Jones, D. E. and Carchman, R. A. 'Application of response surface methods for evaluating the interactions of soman, atropine and pralidioxime chloride', Fundamental and Applied Toxicology, 5, S232-S241 (1985).
26. Finney, D. J. Probit Analysis, 3rd edn, Cambridge University Press, Cambridge, U.K. 1971.
27. Finney, D. J. Statistical Method in Biological Assay, 3rd edn, Griffin, London, U.K. 1978.
28. Fraser, T. R. 'An experimental research on the antagonism between the actions of physostigma and atropia', Proceedings of the Royal Society of Edinburgh, 7, 506-511 (1870-71).
29. Frei, W. 'Versuche uber kombination von desinfektionsrmitteln', Zeitschrift fur Hygiene und Infektionskrankheiten, 75, 433-496 (1912).
30. Genning, C. and Carter, W. H., Jr. 'Utilizing concentration-response data from individual components to detect statistically significant departures from additivity in chemical mixtures', Biometrics, 51, 1264-1277 (1995).
31. Greco, W. R., Brava, G. and Parsons, J. C. 'The search for synergy: A critical review from a response surface perspective', Pharmacological Reviews, 47, 331-385 (1995).
32. Hewlett, P. S. and Plackett, R. L. The Interpretation of Quantal Responses in Biology, Arnold, London, 1979.
33. Kelly, C. and Rice, J. 'Monotone smoothing with application to dose-response curves and the assessment of synergism', Biometrics, 46, 1071-1085 (1990).
34. Khinkis, L. A. and Greco, W. R. 'Analytical solution of the D-optimal design problem for studies of drug synergy', Proceedings of the Biopharmaceutical Section of the American Statistical Association, 323-327 (1993).
35. Laska, E. M., Meisner, M. and Siegel, C. 'Simple designs and model-free test for synergy', Biometrics, 50, 834-841 (1994).
36. Loewe, S. and Muischnek, H. 'Uber kombinationswirkungen. I. Mitteilung: Hilfsmittel der Fragestellung', Naunyn Schmiedebergs Arch. exp. Path. Pharmak, 114, 313-326 (1926).
37. Loewe, S. 'Die quantitative Probleme der Pharmakologie', Ergebn. Physiol, 27, 47-187 (1928).
38. Machado, S. G. and Robinson, G. A. 'A direct, general approach based on isobolograms for assessing the joint action of drugs in pre-clinical experiments', Statistics in Medicine, 13, 2289-2309 (1994).
39. Piserchia, P. V. and Shah, B. V. 'A design for the detection of synergy in drug mixtures', in Proceedings of the Twenty-first Conference on the Design of Experiments in Army Research Development and Testing, Department of Defense, Washington, D.C., 1976, pp. 323-335.
40. Plackett, R. L. and Hewlett, P. S. 'Quantal responses to mixtures of poisons (with discussions)', Journal of the Royal Statistical Society, Series B, 14, 141-163 (1952).
41. Wilson, J. D., Carter, W. H. Jr., Campbell, E. D., Kessler, F. K. and Carchman, R. A. 'Application of response surface methodology to detect interactions of genotoxic agents in cultured mammalian cells', Journal of Toxicology and Environmental Health, 19, 173-183 (1986).
42. Wolf, T. and Unkelbach, H. D. 'The concept of additivity of drug combinations in the case of quantal response', Biometrical Journal, 27, 453-461 (1985).
43. Venditti, J. M., Humphreys, S. R., Mantel, N. and Goldin, A. 'Combined treatment of advanced leukemia (L1210) in mice with amethopterin and 6-mercaptopurine', Journal of the National Cancer Institute, 17, 631-638 (1956).
44. Mantel, N. 'Therapeutic synergism', Cancer Chemotherapy Reports, Part II, 4, 147-149 (1974).
45. D'Agostino, R. B. and Heeren, T. C. 'Multiple comparisons in over-the-counter drug clinical trials with both positive and placebo controls', Statistics in Medicine, 10, 1-6 (1991).
46. Laska, E. M. and Meisner, M. J. 'Comment' on an article by D'Agostino and Heerin, Statistics in Medicine, 10, 17-20 (1991).
47. Dunnett, C. W. and Tamahane, A. C. 'Comparisons between a new drug and active and placebo controls in an efficacy clinical trial', Statistics in Medicine, 11, 1057-1063 (1992).
48. Fraser, T. R. 'The antagonism between the actions of active substances', British Medical Journal, 2, 485-487 (1872).
49. Morgan, B. J. T. Analysis of Quantal Response Data, Chapman and Hall, London, 1992.
50. McCullagh, P. and Neider, J. A. Generalized Linear Models, 2nd edn, Chapman and Hall, London, 1989.
51. Dawson, K. S., Carter, W. H. Jr. and Gennings, C. 'A statistical test for detecting and characterizing departures from additivity in combination drugs', Presented at the Biopharamaceutical Section of the American Statistical Association (August 1996).
52. Andreason, N. C. Modified Scale for the Assessment of Negative Symptoms, Department of Health and Human Services, Public Health Service, Alcohol, Drug Abuse, Mental Health Administration, NIMH Treatment Strategies in Schizophrenia Study, 1984.
53. StatXact, Statistical Software for Exact Nonparametric Inference, User Manual, Version 2, CYTEL Software Corporation, Cambridge, MA, 1991.