|Implemented in this survey?|
The Biomedical Research Centers Network Consortium (CAIBER) was launched by the Institute of Health Carlos III, Madrid, in late 2008. This new consortium gathers 40 hospitals and primary care centers from all over Spain. It will act as a juridic corporation with legal rights and own patrimony. Main objective is to strengthen independent biomedical research and non-profit clinical trial units to improve public health and citizens' wellness during a first period from 2009 to 2012.
The purpose of the new network consortium is twofold:
The Biomedical Research Centers Network Consortium (CAIBER) statutes aim to create a Spanish infrastructure to support independent research and non-commercial clinical trial units. Therefore, its main objectives are specifically described as:
In order to achieve the main objectives a number of non-financial incentives have been foreseen:
Health authorities (regional and central), Health Professionals, Researchers and Patients, Pharmaceutical companies
|Medienpräsenz||sehr gering||sehr hoch|
This health policy derives from the Spanish Law 16/2003 on Cohesion and Quality in the Spanish National Health System (SNHS). The Quality Plan was mentioned in the inaugural address given by President José Luís Rodriguez Zapatero in 2004, and formed part of the accords of the II Conference of Presidents of the Autonomous Communities of Spain, in September 2005, where it was decided to allocate 50 million Euros to the plan annually.
The Quality Plan is designed to benefit citizens and promote high quality health care focused on patients and their needs. It supports health care personnel in the promotion of clinical excellence and in the adoption of best practices based on the best scientific knowledge available. The plan has been in effect for three years - a good time to present a review of activities undertaken thus far (phase I: 2005-2008) and a summary of the actions planned for phase II (2009-2011):
The Quality Plan covers six large action areas that are divided into 12 strategies, 41 objectives and 189 action projects. The areas and strategies are:
Following these strategies, the Biomedical Research Centres Network Consortium (CAIBER) has been created to advance clinical excellence by improving independent research and consequently, to achieve the objectives as laid out in the Quality Plan in the Spanish National Health System (SNHS).
CAIBER is one of the multiple networks and tools to put the Quality Plan and its objectives into action, but is not the only one. Specifically, the CAIBER project is made to achieve strategy number 4 Achieving clinical excellence.
The CAIBER project started in 2009 due to the important necessity to fulfill strategy number 4. During the time in between, no specific network or plan was made to achieve this objective.
Regarding the evaluation of this strategy, there are no current published revisions of the Quality Plan. Nevertheless, the CAIBER project aims to evaluate its objectives once a year.
Spanish Law 16/2003 on Cohesion and Quality in the Spanish National Health System (SNHS).
|Implemented in this survey?|
As mentioned, CAIBER has been established in 2009 due to the development of the Law 16/2003 on Cohesion and Quality in the Spanish National Health System (SNHS). This law aims to achieve clinical excellence by improving research and biomedical knowledge. Consequently, this network consortium focuses its main objective on independent research and non-commercial clinical trials. In order to develop this goal, the CAIBER is settled as a network of health centres (hospitals, primary care centres, research institutes….) who aim to work together and also look for sharing knowledge. The Spanish Ministry of Health and Social Policy throughout the Institute of Health Carlos III (public institution), has given investment to 40 principal institutions (as hospitals, research foundations and primary care centres) all over the country in order to hire research professionals as pharmacologists, physicians, nurses, technicians, adminitrative support, etc…and assets to start this new ambitious net project. The first period will be in between 2009-2012 and CAIBER centres will initially help own independent investigators with no funding to develop their projects. Second, it will build up a non-profit clinical-trial net that focuses on new drugs, new applications and orphan diseases research. Third, it will cooperate with the ECRIN (European Clinical Research Infrastructure network) already in progress since 2007 by European funding and that 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. Fourth, this CAIBER project will train with specific courses, seminars and continuing education their own researchers and professionals.
The approach of the idea is described as:
new: This Biomedical Research Centres Network Consortium (CAIBER) is completely new in Spain and it is establised due to development of the law 16/2003 on Cohesion and Quality in the Spanish National Health Service (SNHS).
Else - This CAIBER project is partly inspired by the European Clinical Research Infrastructure Network (ECRIN) which is a not-for-profit infrastructure supporting multinational clinical research projects in Europe.
see above figure
|Ministry of Health and Social Policy||sehr unterstützend||stark dagegen|
|Institute of Health Carlos III||sehr unterstützend||stark dagegen|
|Regional authorities (autonomous communities)||sehr unterstützend||stark dagegen|
|Central authority (central government)||sehr unterstützend||stark dagegen|
|Pharmaceutical companies||sehr unterstützend||stark dagegen|
|Patients||sehr unterstützend||stark dagegen|
|Civil society||sehr unterstützend||stark dagegen|
|Health professionals and researchers||sehr unterstützend||stark dagegen|
|European Clinical Research Infrastructures Network (ECRIN)||sehr unterstützend||stark dagegen|
|Political parties||sehr unterstützend||stark dagegen|
The government agrees with the idea and they strongly support this project and consequently their research studies. Therefore, independent researchers and patients suffering from rare diseases have been also supportive.
Although no direct beneficiaries of the consortium intiative, even pharmaceutical companies are very interested in this project since they could obtain new drugs applications and in a near future, possibly cooperate and establish joint ventures with this network consortium. They may use this network (and his centers) to develop clinical trials for new drugs and for innovative therapeutic uses. In some cases, they may help to financially support some specific CAIBER projects. Overall, pharmaceutical companies are very supportive not only for selling new drugs but to get a strong network (40 big hospitals and primary care centers around Spain) that may allow them to test new products, using the same procedures and quality standards. It is an important benefit for these companies that actually may help somehow to rebate prices for multicentre clinical trials.
Moreover, the Biomedical Research Centres Network Consortium (CAIBER) will act as a juridic corporation with legal rights and own patrimony. It is composed by a CEO and a board of directors who will agree periodically with the budgets, financial issues and the priorites of funding projects to develop.
|Ministry of Health and Social Policy||sehr groß||kein|
|Institute of Health Carlos III||sehr groß||kein|
|Regional authorities (autonomous communities)||sehr groß||kein|
|Central authority (central government)||sehr groß||kein|
|Pharmaceutical companies||sehr groß||kein|
|Civil society||sehr groß||kein|
|Health professionals and researchers||sehr groß||kein|
|European Clinical Research Infrastructures Network (ECRIN)||sehr groß||kein|
|Political parties||sehr groß||kein|
National researchers see this CAIBER project as an excellent opportunity to receive an extra help to develop independent projects with no external funding. Moreover, patients carrying rare diseases will also see this project as a slender hope to find out new treatments and drugs. The ECRIN project launched by the European Union in 2007 see this new idea an important change to expand its current network.
By now, no specific mechanism of evaluation has been established to review the implementation of this project. Although as an internal evaluation, the CEO and the board of directors will meet periodically in order to evaluate the whole project and the network centres research and clinical trails. Peer review in future publications in scientific journals may be considered a consistent external evaluation.
keine Angaben, Abschlussevaluation (intern)
To date, there has been no direct impact of the Biomedical Research Centres Network Consortium (CAIBER) project on legislative matters mainly because this project itself comes from developing a specific law. Nevertheless, in a near future by providing evidence this project will help the academic community and researchers to better understand new drugs and rare diseases and it will probably have an impact on legislation.
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|
This new consortium aims to achieve its main objective in a short-term period. The first stage will be in between 2009-2012 and during these years it hopes to develop a strong network of excellence in biomedical research and non-profit clinical trials in Spain. To sum up, CAIBER wants to be a platform to improve and reinforce investigation all over the country and also, expand itself to other countries throught the European Clinical Research Infraestructures Network (ECRIN).
Spanish Ministry of Health and Social Policy. Available online at www.msps.es/en/home.htm [consultation April the 10th 2010].
Quality Plan for the National Health System of Spain 2006-2010. Online available atwww.msps.es/organizacion/sns/planCalidadSNS/docs/InformePlanCalidad_ENG.pdf[consultation April the 10th 2010].
European Clinical Reseach Infraestructures Network. Available online at www.ecrin.org/ [consultation April the 14th 2010].