title: Design of multi-centre trials with binary response.
abstract: We propose a correlated beta-binomial model for the binary response in multi-centre trials. The likelihood function in this case has a closed-form and we avoid multivariate numerical integrations in determining the maximum likelihood estimator. Based on derived asymptotic variance-covariance matrix of the MLE, we obtain relatively simple formulae that relate the number of centres, the total number of patients and the precision of the parameter estimate.
authors.affiliation: Research Statistics Unit, Biomedical Data Sciences, GlaxoSmithKline Pharmaceuticals, Collegeville, PA 19426-0989, USA. vladimir.2.dragalin@gsk.com
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dragalin
authors.forename: Valerii
authors.initials: V
authors.lastname: Fedorov
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D006801:Humans; D016013:Likelihood Functions; D016014:Linear Models; D015233:Models, Statistical; D015337:Multicenter Studies as Topic / Q000379:methods* / Q000706:statistics & numerical data