Antonio Juan-Ribelles, Francisco Bautista, Adela Cañete, Alba Rubio-San-Simón, Anna Alonso-Saladrigues, Raquel Hladun, Susana Rives, Jose Luís Dapena, Jose María Fernández, Álvaro Lassaletta, Ofelia Cruz, Gemma Ramírez-Villar, Jose Luís Fuster, Cristina Diaz de Heredia, Miguel García-Ariza, Eduardo Quiroga, María del Mar Andrés, Jaime Verdú-Amorós, Antonio Molinés, Blanca Herrero, Mónica López, Catalina Márquez, María Toboso, Frencisco Lendínez, Jose Gómez Sirvent, María Tallón, Guiomar Rodríguez, Tomás Acha, Lucas Moreno, Ana Fernández-Teijeiro
{"title":"ECLIM-SEHOP:如何开发儿童癌症学术试验平台","authors":"Antonio Juan-Ribelles, Francisco Bautista, Adela Cañete, Alba Rubio-San-Simón, Anna Alonso-Saladrigues, Raquel Hladun, Susana Rives, Jose Luís Dapena, Jose María Fernández, Álvaro Lassaletta, Ofelia Cruz, Gemma Ramírez-Villar, Jose Luís Fuster, Cristina Diaz de Heredia, Miguel García-Ariza, Eduardo Quiroga, María del Mar Andrés, Jaime Verdú-Amorós, Antonio Molinés, Blanca Herrero, Mónica López, Catalina Márquez, María Toboso, Frencisco Lendínez, Jose Gómez Sirvent, María Tallón, Guiomar Rodríguez, Tomás Acha, Lucas Moreno, Ana Fernández-Teijeiro","doi":"10.1007/s12094-024-03445-0","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The platform’s database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months.</p><h3 data-test=\"abstract-sub-heading\">Discussion</h3><p>ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.</p>","PeriodicalId":10166,"journal":{"name":"Clinical and Translational Oncology","volume":"36 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2024-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer\",\"authors\":\"Antonio Juan-Ribelles, Francisco Bautista, Adela Cañete, Alba Rubio-San-Simón, Anna Alonso-Saladrigues, Raquel Hladun, Susana Rives, Jose Luís Dapena, Jose María Fernández, Álvaro Lassaletta, Ofelia Cruz, Gemma Ramírez-Villar, Jose Luís Fuster, Cristina Diaz de Heredia, Miguel García-Ariza, Eduardo Quiroga, María del Mar Andrés, Jaime Verdú-Amorós, Antonio Molinés, Blanca Herrero, Mónica López, Catalina Márquez, María Toboso, Frencisco Lendínez, Jose Gómez Sirvent, María Tallón, Guiomar Rodríguez, Tomás Acha, Lucas Moreno, Ana Fernández-Teijeiro\",\"doi\":\"10.1007/s12094-024-03445-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Introduction</h3><p>ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation.</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>The platform’s database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months.</p><h3 data-test=\\\"abstract-sub-heading\\\">Discussion</h3><p>ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.</p>\",\"PeriodicalId\":10166,\"journal\":{\"name\":\"Clinical and Translational Oncology\",\"volume\":\"36 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-04-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Translational Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s12094-024-03445-0\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Translational Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s12094-024-03445-0","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
ECLIM-SEHOP: how to develop a platform to conduct academic trials for childhood cancer
Introduction
ECLIM-SEHOP platform was created in 2017. Its main objective is to establish the infrastructure to allow Spanish participation into international academic collaborative clinical trials, observational studies, and registries in pediatric oncology. The aim of this manuscript is to describe the activity conducted by ECLIM-SEHOP since its creation.
Methods
The platform’s database was queried to provide an overview of the studies integrally and partially supported by the organization. Data on trial recruitment and set-up/conduct metrics since its creation until November 2023 were extracted.
Results
ECLIM-SEHOP has supported 47 studies: 29 clinical trials and 18 observational studies/registries that have recruited a total of 5250 patients. Integral support has been given to 25 studies: 16 trials recruiting 584 patients and nine observational studies/registries recruiting 278 patients. The trials include front-line studies for leukemia, lymphoma, brain and solid extracranial tumors, and other key transversal topics such as off-label use of targeted therapies and survivorship. The mean time from regulatory authority submission to first patient recruited was 12.2 months and from first international site open to first Spanish site open was 31.3 months.
Discussion
ECLIM-SEHOP platform has remarkably improved the availability and accessibility of international academic clinical trials and has facilitated the centralization of resources in childhood cancer treatment. Despite the progressive improvement on clinical trial set-up metrics, timings should still be improved. The program has contributed to leveling survival rates in Spain with those of other European countries that presented major differences in the past.