Johanna Teloh-Benger, Susanne Isfort, Norbert Gattermann, Ingo G H Schmidt-Wolf, Martina Crysandt, Angelika Kötting, Annett Falkenhahn, Olivia Hardebeck, Kristoffer Lenssen, Alexander Werz, Alexandra Krüger, Thomas Zander
{"title":"在德国一家由四所大学医院组成的联合综合癌症中心,引入了一种参与临床试验的新卫星模式。","authors":"Johanna Teloh-Benger, Susanne Isfort, Norbert Gattermann, Ingo G H Schmidt-Wolf, Martina Crysandt, Angelika Kötting, Annett Falkenhahn, Olivia Hardebeck, Kristoffer Lenssen, Alexander Werz, Alexandra Krüger, Thomas Zander","doi":"10.1159/000541038","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model.</p><p><strong>Methods: </strong>In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law).</p><p><strong>Conclusion: </strong>Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. The satellite model developed is intended to give patients broader access to medical innovations in cancer therapy.</p>","PeriodicalId":19543,"journal":{"name":"Oncology Research and Treatment","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Introduction of a New Satellite Model for Participation in Clinical Trials in a Consortial Comprehensive Cancer Center with Four University Hospitals in Germany.\",\"authors\":\"Johanna Teloh-Benger, Susanne Isfort, Norbert Gattermann, Ingo G H Schmidt-Wolf, Martina Crysandt, Angelika Kötting, Annett Falkenhahn, Olivia Hardebeck, Kristoffer Lenssen, Alexander Werz, Alexandra Krüger, Thomas Zander\",\"doi\":\"10.1159/000541038\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model.</p><p><strong>Methods: </strong>In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law).</p><p><strong>Conclusion: </strong>Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. 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Introduction of a New Satellite Model for Participation in Clinical Trials in a Consortial Comprehensive Cancer Center with Four University Hospitals in Germany.
Introduction: The trend toward personalized medicine leads to very small study cohorts for clinical trials, which makes it difficult to recruit patients in a single study center. On the other hand, the administrative effort required to initiate a clinical trial is very high. As a result, Germany runs the risk of falling behind other countries as a trial location. For this reason, the Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) has been working on the challenge of a new satellite model in which the main trial center is the only one to conclude a trial center contract with the sponsor and also handles all formalities with it. The remaining sites constitute the satellites. In contrast to former satellite models, the entire study-related interventions are carried out at each site in the present model.
Methods: In order to evaluate the approvability of the model, contact was made with both higher federal authorities and the responsible inspectorate, and none of them declared themselves responsible for a possible basic approval. The four ethics committees contacted agreed to the model subject to certain framework conditions. In addition, the model was validated by the preparation of several legal opinions on various issues (medical, labor, antitrust law).
Conclusion: Study participation close to home is a decisive advantage for multimorbid patients. As up to four locations form a trial site in the model, a large catchment area can be covered with reduced administrative costs. The satellite model developed is intended to give patients broader access to medical innovations in cancer therapy.
期刊介绍:
With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.