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More than 430 children participate in trials at new Sant Joan de Déu pediatric unit

This is the first Spanish hospital to offer a ‘single window’ service to manage and coordinate internal and external clinical trials in pediatrics.

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13.12.2012

Isabel Muntané

Sant Joan de Déu Hospital in Esplugues de Llobregat has created a pediatrics clinical-trial unit to improve specialized clinical research in this field and boost their presence internationally.

“There are currently few drugs to treat specific childhood diseases like certain types of cancer and neurological diseases like Duchenne muscular dystrophy, among others”, explains Joana Claverol, coordinator of the new unit. To this end, the unit’s team, a total of six people, is working on trials geared towards evaluating new treatments, new applications for drugs already on the market, and developing other aspects of drugs already approved, focusing on these pediatric diseases. They are also carrying out studies on healthcare products (devices) and nutritional products.

Joana Claverol: “This way, researchers can focus on their research and not waste time on bureaucratic paperwork "

This service, the first of its kind in Spain, is currently carrying out 33 commercial trials (promoted by the pharmaceutical industry) and 13 non-commercial trials with more than 430 children and in collaboration with other units of the hospital like oncology, infectious diseases, neurology, rheumatology, endocrinology, immunology, neonatology and surgery. They have also done 12 commercial and 4 non-commercial trials with adult samples in collaboration with the Sant Joan de Déu Health Park in Sant Boi de Llobregat in the fields of psychiatry, mental health and pulmonology.

The work this unit is doing focuses on providing methodological guidance for researchers, transforming the idea behind the research into a trial protocol. And they do this by providing legal advisory services and seeking out funding through the Sant Joan de Déu Foundation. “This way, researchers can focus on their research and not waste time on bureaucratic paperwork. Moreover, the fact that we deal with all the bureaucratic paperwork for project approval at once makes the process move more quickly,” adds Claverol. The unit’s own nurses are in charge of coordinating families, researchers and sponsors. The fact that there is only one contact makes the process easier for both hospital personnel and external clients that approach the hospital in search of support for their research.

This new single-window approach to the management of the trials and healthcare processes with areas of the hospital devoted specifically to this unit, an outpatient clinic, an inpatient area and a laboratory, “makes clinical trials more efficient, taking children out of the healthcare circuit and speeding up the process of the study”, explains Claverol. “Our project can be summed up by saying that we ensure that clinical trials are carried out in accordance with ethical standards, current legal regulations and guidelines for good clinical practice, efficiency and quality,” concludes the coordinator of the unit.

Laura Solé, Joan Vinent, Alba Murciano, Palmira Santin and Joana Claverol, of the new trials unit - Photo: Diario Médico.

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