DISEÑOS ADAPTATIVOS PARA ENSAYOS CLÍNICOS FASE II O III EN PACIENTES CON CANCER EN CUBA

Abstract

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