Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Table 1. Examples of multicenter trials undertaken by independent clinical investigators.Trial Number of centers Number of patients Outcome Reference(countries involved) recruited/samplesize for ongoing trialCESAR 98 online and 180 Death or severe www.cesar-trial.orgrecruitment ofdisability at 6 monthscenters ongoing (UK)post-randomizationCRASH 239 online 10,008 Death from any cause [5,6]and recruitmentwithin 2 weeks of injuryof centersDeath or neurological(UK and overseas)deficit at 6 monthsMAGPIE 193 (33 countries) 10,141 Eclampsia [7]Death of babyORACLE 161 (15 countries) 4,826 Neonatal death/ [8]chronic lung diseaseor major cerebralabnormality onultrasonographybefore dischargeOSIRIS 229 (21 countries) 6,774 Death or oxygen [9]dependence at 28 daysDeath or oxygendependence atexpected date ofdeliveryRITA 3 56 (UK) 1,810 Death, myocardial [10]infarction, orrefractory anginaat 4 monthsDeath or myocardialinfarction at 1 yearTMC 8 (UK and Republic 606 Death, retransplantation, [11]of Ireland)or treatment failure forimmunologic reasonsUK collaborative 55 (UK) 185 Death or severe [12]trial of neonataldisability atextracorporeal12 monthsmembraneoxygenationCESAR = Conventional Ventilation or Extra Corporeal Membrane Oxygenation for Severe Adult Respiratory Failure;CRASH = Corticosteroid Randomisation After Significant Head Injury; MAGPIE = Magnesium Sulphate or Placebofor Women with Pre-Eclampsia; ORACLE = Broad Spectrum Antibiotics for Preterm, Prelabour Rupture of FetalMembranes; OSIRIS = Open Study of Infants at High Risk of or with Respiratory Insufficiency – the Role of Surfactant;RITA 3 = Noninvasive Versus Invasive (Angiography) in Patients with Unstable Angina or Non-Q Wave Infarct;TMC = Tacrolimus Versus Microemulsified Cyclosporin in Liver Transplantation.155