Clinical Trials

❘❙❚■ Chapter 29 | Multiplicityspecifying the priorities of analysis in terms of primary and secondary importance,and reducing the significance threshold if needed.References1. Bland JM, Altman DG. Multiple significance tests: the Bonferroni method. BMJ 1995;310:170.2. Sakkers R, Kok D, Engelbert R, et al. Skeletal effects and functional outcome with olpadronatein children with osteogenesis imperfecta: a 2-year randomised placebo-controlled study.Lancet 2004;363:1427–31.3. Baum M, Budzar AU, Cuzick J, et al. Anastrozole alone or in combination with tamoxifen versustamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer:first results of the ATAC randomised trial. Lancet 2002;359:2131–9.4. Assmann SF, Pocock SJ, Enos LE, et al. Subgroup analysis and other (mis)uses of baseline datain clinical trials. Lancet 2000;355:1064–9.5. Bonferroni CE. Teoria statistica delle classi e calcolo delle probabilita. Publicazioni del R InstitutoSuperiore die Scienze Economiche e Commerciali di Firenze 1936;8:3–62 (in Italian).6. von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrelfor emergency contraception: a WHO multicentre randomised trial. Lancet 2002;360:1803–10.7. Hsu JC. Multiple Comparisons – Theory and Methods. London: Chapman & Hall, 1996.8. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials.London: Chapman & Hall, 2000.9. Chow SC, Liu P. Design and Analysis of Clinical trials: Concepts and Methodologies. New York:John Wiley & Sons, 1998.10. Comelli M. Multiple Endpoints. In: Encyclopaedia of Biopharmaceutical Statistics. Chow SC, editor.New York: Marcel Dekker Inc, 2003:333–43.11. Vardy A. Statistics. In: Handbook of Clinical Research, 2nd edition. Lloyd J, Raven A, editors.London: Churchill Medical Communications, 1994:334–63.12. Fox KA, Poole-Wilson PA, Henderson RA, et al. Interventional versus conservative treatmentfor patients with unstable angina or non-ST-elevation myocardial infarction: the British HeartFoundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina.Lancet 2002;360:743–51.13. Wei LJ, Lachin JM. Two-sample asymptotically distribution free tests for incomplete multivariateobservations. J Am Stat Assoc 1984;79:653–61.14. Hartung HP, Gonsette R, Konig N, et al. Mitoxantrone in progressive multiple sclerosis:a placebo-controlled, double-blind, randomised, multicentre trial. Lancet 2002;360:2018–25.15. Senn S. Multiplicity. Section 10. In: Statistical Issues in Drug Development. Chichester: John Wiley& Sons, 1997:141–52.338