Discussion
Clinical trials are used to determine the most effective and safe treatments for a given disease. In childhood cancer, each trial aims at improving survival, reducing side effects or long-term sequelae of treatment. In some countries of Western Europe, participation in clinical trials has become the standard of care in children and adolescents with cancer.
To date, infrastructure and support to facilitate participation in academic international multicenter collaborative clinical trials in pediatric cancer in Spain has not matched the same standards than other European countries such as France, Germany or the United Kingdom. Initiatives like SCReN (Spanish Clinical Research Network,
http://www.scren.es) provide excellent support to some clinical trials, but so far, have had limited resources and could not cover all the needs from the pediatric oncology community.
Historically, Spain has not been able to participate in multiple international clinical trials because of the above-mentioned lack of resources and infrastructure to adapt to modern regulatory standards and provide good quality data. For some other studies, the time to setup the trials in our country has been so long due to administrative barriers that the trials were completed or nearly completed internationally by the time the trials were open.
The participation of our country in international clinical trials makes a huge contribution to our society for several reasons: (1) clinical trials evaluate more novel strategies and offer access to new treatments, (2) treatment within clinical trials is always done in centers with proven experience, with less variability and greater control of toxicities that may appear, being safer than being treated outside trials, (3) clinical trials allow to advance scientific knowledge and improve results of childhood cancer therapy and (4) collaboration at national and international level is essential to improve the results in such a significant group of rare diseases.
In our country, survival of childhood cancer has improved significantly in recent years, but the data are still below that of other neighboring countries in Western Europe such as France, the United Kingdom or Italy. For example, in the case of lymphoblastic leukemia, the EUROCARE5 study and a national study of the Registro Nacional de Tumores Infantiles (RETI-SEHOP) have reported lower survival rates in Spain (83%) compared to France (90%), Germany (90%), Italy (89%) or United Kingdom (88%) [
4,
18].
With the implementation of the first European Clinical Trial Directive in 2001, the development and conduct of academic clinical trials entailed a significant burden of administrative duties at the international, national and local levels. These tasks surely exceed the capacity of individual clinical investigators in charge of each study as national coordinators. It was, therefore, necessary to provide support for all the new international clinical trials that are being implemented and maintain a stable and organized infrastructure to carry out these activities.
Since 2004, there has been a progressive improvement in our performance metrics as a country in clinical trial setup and conduct [
19]. This positive change is due, among other factors, to changes in current legislation, learning curve of participating institutions and ethics committees.
Most of the activity in oncology clinical trials carried out in Spain is dependent on the pharmaceutical industry, which is surely more focused on new drug development, rather than on standard clinical practice, procedures such as transplant or surgery, radiotherapy or medical devices, and does not necessarily respond to the capabilities and opportunities of the clinical and academic research ecosystem, nor to the epidemiological reality of cancer in our country [
20]. In Spain, 76% of this activity is industry sponsored, compared to that of 49% in France, 56% in the Netherlands, 62% in Italy or 65% in the United Kingdom. To improve our capacity to innovate in the field of clinical research, and achieve the goal that every child and adolescent in our country can potentially be included in a clinical trial, it is necessary for the Spanish public institutions to have greater funding and capabilities to develop more academic trials and implement collaborative international plans. ECLIM-SEHOP is supported with funds from competitive grants from the Asociación Española Contra el Cancer (AECC) and Fundación Inocente as well as other non-competitive contributions from non-profit organizations, mainly Federación Española de Padres de Niños con Cáncer, Asociación Pablo Ugarte y Fundación Mar, and, therefore, in constant need of identifying financial resources to make it sustainable. Still, our clinical trial setup metrics can be improved by far. Hopefully, the data provided here will serve as a baseline for future comparisons and, with time, the timelines to open clinical trial will shorten, so that these new advances reach our patients as soon as possible.
In summary, thanks to the enormous work and generosity of SEHOP members that are leading on these clinical trials and all stakeholders involved in this process, including parents, patients and other healthcare professionals, together with the help of the ECLIM-SEHOP platform we will facilitate Spanish children and adolescents diagnosed with cancer and blood disorders to access state-of-the-art diagnostic and therapeutic strategies, and in this way continue to improve survival rates and decreasing the side effects of long-term treatment.
Acknowledgements
We would like to thank all children and parents who participate in clinical trials and the clinical staff, research nurses, and research assistants of the different institutions. We thank the members of the technical secretariat of the Sociedad Española de Hematología y Oncología Pediátrica (SEHOP) and Fundación SEHOP, particularly Inmaculada Toledano and Falastin Eljishi for their continued work, support and enthusiasm. We thank Patricio Ledesma, Head of Clinical Operations as well as all the staff at Sofpromed Investigación Clínica, for the close and fruitful collaboration in building up ECLIM-SEHOP. We are grateful to our colleagues of SEHOP and their teams (physicians, nurses, study coordinators, etc.) for their interest and commitment on clinical research to improve care for children with cancer and hematological diseases. We would specially like to thank Dr. Tomás Acha who, during his term as president of SEHOP, was the first to propose that a platform to support Spanish physicians and investigators was necessary to foster clinical research in pediatric cancer and blood disorders so that Spanish children had the same treatment opportunities as their peers in other European countries; he set up the foundations for the current ECLIM-SEHOP platform to be developed, together with the help of the SEHOP Executive Committee.
Compliance with ethical standards
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