Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘have examined some key issues, such as the need for, design of, and practicalitiesof coordinating multicenter trials. Careful consideration of these issues during thevarious stages of trial protocol development and coordination is important to thesuccess of multicenter trials.References1. Chalmers I. Unbiased, relevant, and reliable assessments in health care: important progressduring the past century but plenty of scope for doing better. BMJ 1998;317:1167–8.2. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials?Stat Med 1984;3:409–20.3. Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. New York:Springer-Verlag, 1998.4. Pocock SJ. Clinical Trials: A Practical Approach. New York: John Wiley & Sons, 1983.5. MRC CRASH Trial Collaborative Group. Effect of intravenous corticosteroids on deathwithin 14 days in 10,008 adults with clinically significant head injury (MRC CRASH trial):randomised placebo-controlled trial. Lancet 2004;364:1321–8.6. Wasserberg J. Assessing corticosteroid treatment for severe head injury. Clinical Researcher2001;1(3):21–5.7. The Magpie Trial Collaborative Group. Do women with pre-eclampsia, and their babies,benefit from magnesium sulphate? The Magpie Trial: a randomised placebo controlled trial.Lancet 2002:359:1877–90.8. Kenyon SL, Taylor DJ, Tarnow-Mordi W (for the ORACLE Collaborative Group). Broadspectrum antibiotics for preterm, prelabour rupture of fetal membranes: The ORACLE 1randomised trial. ORACLE Collaborative Group. Lancet 2001;357:979–88.9. The OSIRIS Collaborative Group. Early versus delayed neonatal administration of a syntheticsurfactant – the judgment of OSIRIS. The OSIRIS Collaborative Group (open study of infantsat high risk of or with respiratory insufficiency – the role of surfactant). Lancet 1992;340:1363–9.10. Fox KAA, Poole-Wilson PA, Henderson RA. Interventional versus conservative treatmentfor patients with unstable angina or non-ST-elevation myocardial infarction: the British HeartFoundation RITA 3 randomised trial. Lancet 2002;360:743–51.11. O’Grady JG, Burroughs A, Hardy P, et al. (for the UK and Republic of Ireland Liver TransplantStudy Group). Tacrolimus versus microemulsified ciclosporin in liver transplantation: the TMCrandomised controlled trial. Lancet 2002;360:1119–25.12. UK Collaborative ECMO Trial Group. UK collaborative randomised trial of neonatalextracorporeal membrane oxygenation. Lancet 1996;348:75–82.13. Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirinfollowed by long-term therapy in patients undergoing percutaneous coronary intervention:the PCI-CURE study. Lancet 2001;358:527–33.14. Flather M, Aston H, Stables RH, editors. Handbook of Clinical Trials. London: Remedica, 2001.15. Farrell B. Efficient management of randomised controlled trials: nature or nurture.BMJ 1998;317:1236–9.163