Search

Resumen El objetivo de este articulo es ilustrar como poner en marcha y desarrollar un estudio multicentrico prospectivo, controlado y aleatorizado. Por ello, lo primero que se necesita es crear una idea que genere una hipotesis y un objetivo principal. La busqueda bibliografica nos permite ver su relevancia clinica y las evidencias publicadas. Ademas, hay que plantearse si el estudio es viable economicamente y si puede ser completado en un periodo menor a 4 anos. Una vez ideado el estudio multicentrico, para ejecutarlo se debe redactar un protocolo (segun la guia Standard Protocol items: Recommendations for Interventional Trials [SPIRIT 2013]). En el se recogeran el tipo de diseno, el tamano muestral y los centros que participaran. La aleatorizacion es clave en el diseno. Si puede ser aleatorizado, se recomienda utilizar la guia Consolidated Standards of Reporting Trials (CONSORT), si no, la Transparent Reporting of Evaluations with Non-Randomized Designs (TREND). Cuando el protocolo es aprobado por el Comite Etico de Investigacion Clinica del hospital, hay que darle visibilidad. Es por eso que se recomienda su registro en ClincalTrials.gov y su publicacion en revistas indexadas. Para el inicio del estudio, se requiere buscar fuentes de financiacion. Estas permiten tener una base de datos on line, que permiten aleatorizar al momento y mantener el registro al dia desde cualquier centro. Por ultimo, hay que destacar que es imprescindible la motivacion. La multicentricidad solo se entiende si todos los centros participan. Asi que informar de resultados y dar animos cada 1-3 meses (en forma de newsletter) es una manera de conseguir un buen funcionamiento del estudio.

Our main goal is to describe how to start and develop a multicenter, prospective, randomized, controlled trial. The first step is to have an idea that will become the hypothesis and a main objective. A bibliographic search should be done to check for clinical interest and originality. Moreover, the study must be feasible and should be finished within 4 years. In order to start the multicenter study, a protocol should be written (in accordance with the SPIRIT guidelines Standard Protocol items: Recommendations for Interventional Trials), including the design type, sample size and participating hospitals. Randomization is key to the design and, therefore, the CONSORT (Consolidated Standards of Reporting Trials) guidelines must be followed. However, if the study cannot be randomized, the TREND (Transparent Reporting of Evaluations with Non-Randomized Designs) guidelines are recommended. When the protocol is approved by the Ethics Committee for Clinical Investigation of the hospital, we ought to create visibility. It is suggested to register the trial on ClincalTrials.gov and submit its publication to indexed magazines. Financial resources are necessary to execute the study and maintain an online database. This allows the registry to be updated and accessible to all the participants in the study. What is more, randomization can be done immediately. And last, but not least, is motivation. Multicentricity equals to participation of all the chosen medical centers. Updating and motivating them by sending a newsletter every 1-3 months keeps participants engaged in the study.