1. Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience
- Author
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Francesca Saluzzo, Juan Espinosa-Pereiro, Stephan Dressler, Ezio Tàvora Dos Santos Filho, Stephanie Seidel, Jesus Gonzalez Moreno, Norbert Heinrich, Adrian Sanchez-Montalva, Daniela Maria Cirillo, Institut Català de la Salut, [Saluzzo F] Vita-Salute San Raffaele University, Milan, Italy. Division of Immunology, Transplantation & Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy. [Espinosa-Pereiro J] Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Global Health Program from the Catalan Health Institute (PROSICS), Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. [Dressler S] EU-PEARL: EU Patient-cEntric clinicAl tRial pLatforms, WP5 – Integrated Research Platform for Tuberculosis (TB) Community Advisory Group, Berlin, Germany. [Tàvora Dos Santos Filho E] EU-PEARL: EU Patient-cEntric clinicAl tRial pLatforms, WP5 – Integrated Research Platform for Tuberculosis (TB) Community Advisory Group, Rio De Janeiro, Brazil. [Seidel S] Community Engagement and Stakeholder Relations, Global Alliance for TB Drug Development, New York, USA. [Gonzalez Moreno J] Janssen-Cilag S.A. Spain, Part of Janssen Pharmaceutical Companies, Madrid, Spain. [Sanchez-Montalva A] Servei de Malalties Infeccioses, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Global Health Program from the Catalan Health Institute (PROSICS), Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain. Mycobacterial Infection Study Group from the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIM-SEIMC), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Health Services Administration::Patient Care Management::Comprehensive Health Care::Primary Health Care::Patient-Centered Care [HEALTH CARE] ,Microbiology (medical) ,Participació comunitària ,Atenció centrada en el pacient ,Tuberculosi - Tractament ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Health Care Facilities, Manpower, and Services::Health Services::Community Health Services::Community Participation [HEALTH CARE] ,General Medicine ,administración de los servicios de salud::gestión de la atención al paciente::atención integral de salud::atención primaria de la salud::atención centrada en el paciente [ATENCIÓN DE SALUD] ,instalaciones, servicios y personal de asistencia sanitaria::servicios de salud::Servicios de Salud Comunitaria::participación de la comunidad [ATENCIÓN DE SALUD] ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Infectious Diseases ,infecciones bacterianas y micosis::infecciones bacterianas::infecciones por bacterias grampositivas::infecciones por Actinomycetales::micobacteriosis::tuberculosis [ENFERMEDADES] ,Bacterial Infections and Mycoses::Bacterial Infections::Gram-Positive Bacterial Infections::Actinomycetales Infections::Mycobacterium Infections::Tuberculosis [DISEASES] - Abstract
Community engagement; Tuberculosis research Participación de la comunidad; Investigación de la tuberculosis Compromís comunitari; Recerca en tuberculosi Objectives: Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the trial schedule. The early engagement of the community will, later in time, support the process of implementation of new policies designed for successful products. We aim at developing a structured protocol for the early engagement of TB community representatives developed in the context of the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. Design: The EU-PEARL Innovative Medicine Initiative 2 (IMI2) project TB work package has developed a community engagement (CE) framework to ensure fair and efficient participation of the community in the design and implementation of TB clinical platform trials. Results: We showed that early engagement of the EU-PEARL community advisory board highly contributes to the process of development of a community-acceptable Master Protocol Trial and Intervention-Specific Appendixes. We identified capacity building and training as major gaps in advancing CE in the TB field. Conclusion: Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research. This work is partially supported by EU-PEARL. EU-PEARL has received funding from the InnovativeMedicines Initiative 2 Joint Undertaking under grant agreement No 853966. This Joint Undertaking receivessupport from the European Union’s Horizon 2020 research and innovation program and EFPIA and Children’sTumor Foundation, Global Alliance for TB Drug Development non-profit organization, SpringworksTherapeutics Inc. This publication reflects the authors’ views. Neither IMI nor the European Union,EFPIA,or any Associated Partners are responsible for any use that may be made of the information contained hereinDMC is the co-leader of EU-PEARL WP5. ASM is supported by a Juan Rodés (JR18/00022) postdoctoral fellowship from ISCIII. FS salary is supported by EU-PEARLgrant to UniSR.
- Published
- 2023