Diseños adaptativos para ensayos clínicos fase II o III en pacientes con cáncer en Cuba

作者: L. Martínez Pérez , M.M. Fors López , B. Wilkinson Brito , C.E. Viada Gómez , M. Troche Concepción

DOI:

关键词: SurgeryTreatment and control groupsClinical trialIntensive care medicineResponse adaptive randomizationSample size determinationMedicine

摘要: The Center of Molecular Immunology (CIM) has developed since its creation, different molecules for the treatment cancer. development these products, allowed an advance in clinical trials phases. This brings consequently increment number studies and also hospitals recruiting patients. In this moment, we are working with 15 more than 50 trials, a prognostic including 2500 patients per year, maintaining follow-up 350 included year. With objective accelerating process biotechnical to reduce time placing market new product costs investigations, adaptation designs ongoing were introduced sample size re-estimation, early stopping due efficacy or futility, response adaptive randomization, dropping inferior groups. paper described advantages disadvantages compared conventional it is shown proposed modifications by our center design 4 kind cancers like lung glioma.

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