Vita-Salute San Raffaele University, Milan, Italy; Division of Immunology, Transplantation & Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Infectious Diseases Department, Vall d'Hebrón University Hospital, Global Health Program from the Catalan Health Institute (PROSICS), Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain.
Int J Infect Dis. 2023 May;130 Suppl 1:S20-S24. doi: 10.1016/j.ijid.2023.03.008. Epub 2023 Mar 9.
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.
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.
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.
Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research.
社区代表是确保结核病（TB）研究具有相关性、文化敏感性和适当性的关键。对于所有试验（新药或治疗方案、诊断方法或疫苗），这可以提高招募、保留和遵守试验计划的效果。社区的早期参与将在以后支持为成功产品设计的新政策的实施过程。我们旨在为欧盟-以患者为中心的临床试验平台（EU-PEARL）项目背景下制定一项早期接触结核病社区代表的结构化方案。
欧盟-PEARL 创新药物倡议 2（IMI2）项目的结核病工作包制定了一项社区参与（CE）框架，以确保社区公平有效地参与 TB 临床平台试验的设计和实施。
我们表明，欧盟-PEARL 社区咨询委员会的早期参与高度有助于制定社区可接受的主协议试验和干预特定附录的过程。我们确定能力建设和培训是推进结核病领域社区参与的主要差距。
制定解决这些需求的策略有助于防止象征性参与，并提高结核病研究的可接受性和适当性。
