[Evaluation process of a clinical trial from the EC's point of view].
Following two years of experience with the procedure of "single ruling", we are far from achieving it objectives of promoting European clinical research, reducing the need to initiate multicenter clinical trials. We have observed the need to harmonize criteria between the different ECs and greater involvement by the Spanish Drug and Health Care Products Agency and Site. It should be stated that in our experience clinical trials have only been rejected due to reasons inherit the protocol itself, such as irregularities in its design or because if was considered that no scientific information was supplied. The study has never been rejected due to problems related with the documentation attached, such as patient information sheet, financial report, etc., which, however, generate many clarifications with the subsequent increase in administrative work. For this reason another way of facilitating the process would be to establish greater coordination between sponsors, CROs and investigators, both before sending the protocol for evaluation to the EC as well as when responding to all the clarifications requested.
Gálvez Múgica
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MA
Agencia de Ensayos Clínicos, Hospital Ramón y Cajal, Madrid, España. mgalvez.hrc@salud.madrid.org
de Pablo López de Abechuco
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I
D002986:Clinical Trials as Topic / Q000592:standards*; D028741:Ethics Committees, Clinical; D006801:Humans; D013030:Spain