ECRIN funds clinical trials to augment rare disease research
The European Clinical Research Infrastructures Network (ECRIN) is a non-profit organisation that supports multinational academic clinical research projects in Europe which is "hampered by the fragmentation of health and legislative systems in Europe". ECRIN provides information, consulting and services to investigators and sponsors in the preparation and in the conduct of multinational clinical studies, for any category of clinical research and in any disease area. This is particularly relevant for investigator-initiated or academic clinical trials, and for clinical research on rare diseases where international cooperation is a key success factor. ECRIN is based on the connection of coordinating centres for national networks of clinical research centres and clinical trials units, able to provide support and services to multinational clinical research.
Recently, ECRIN organised a call for applications to allow multinational extension of trials already funded in the coordinating country in three specific areas: Nutrition, Medical Devices and Rare Diseases. Trials were proposed by public or private non-profit institutions, and to address important clinical questions. The evaluation process was based on the possible impact on the health of European citizens, the scientific merit and excellence, and the feasibility of each proposed trial. Project selection was carried-out by the ECRIN IA Scientific Board (which also includes patients representatives), supported by external peer-reviewers, each assessing one clinical trial in his/her specific field of competence, and three methodologists, each assessing all the trials pertaining to one of the clinical areas considered by the call. The ECRIN European Correspondents provided the Board with an estimation of the logistical feasibility and cost of the trials. Eight clinical trials, involving a total of 21 European countries, were recommended for free access to ECRIN services after selection by the ECRIN-IA Scientific Board convened in Milan on June 20-21, 2013 : Four of the trials chosen are in the field of rare disease research. Below are the details of the trials to be funded involved in rare disease research:
Prospective multicenter study (phase III) to evaluate clinical efficacy and safety of anti-Pseudomonas antibodies (IgY) in prevention of P. aeruginosa infection in CF patients PsAerIgY – Trial Germany 4.0 Clobazam or steroids for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
Clobazam or steroids for ESES syndrome: a European, multicenter, randomized, controlled clinical trial
Very early FDG-PET/CT-response adapted therapy for advanced stage Hodgkin Lymphoma, a randomized phase III noninferiority study
Endoscopic versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial