The FIOCRUZ Therapeutic and Prevention HIV/AIDS Clinical Trials Unit.

FIOCRUZ 治疗和预防艾滋病毒/艾滋病临床试验单位。

• 批准号: 10531198
• 负责人: BEATRIZ GRINSZTEJN
• 金额: $ 152.83万
• 依托单位: FUNDACAO OSWALDO CRUZ
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-01-15 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10531198
• 关键词: AIDS clinical trial group; AIDS prevention; Advocate; Affect; Authorization documentation; Belief; Brazil; Caring; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Unit; Collaborations; Communicable Diseases; Communication; Communities; Developing Countries; Ensure; Epidemic; European; Foundations; Funding; Gender; Generations; Goals; Good Clinical Practice; HIV; HIV Vaccine Trials Network; HIV/AIDS; HIV/TB; Health Personnel; Hepatitis; Hospitals; Individual; Infection; Leadership; Licensure; Nongovernmental Organizations; Participant; Population; Prevention; Process; Public Health; Race; Research; Research Personnel; Rewards; Risk; Sex Orientation; Site; Solid; Standardization; Therapeutic; Tuberculosis; United States National Institutes of Health; Vulnerable Populations; authority; clinical research site; community involvement; comorbidity; experience; global health; improved; innovation; insight; international center; novel; programs; social; success

FioTrials Abstract The FioTrials CTU, based at the Oswaldo Cruz Foundation - FIOCRUZ (Rio de Janeiro, Brazil), is led by Dr. Beatriz Grinsztejn and supported by a cadre of experienced researchers and promising junior investigators. FioTrials is affiliated with FIOCRUZ, an international center of excellence in the field of public health and infectious diseases. The FioTrials CTU promotes and rewards innovation, while providing a standardized, formal approach to the implementation and management of clinical trials. The CTU has successfully implemented and conducted pivotal clinical trials for multiple NIH-sponsored Networks that have changed the landscape of HIV and Tuberculosis (TB) prevention and treatment during the last 14 years. The FioTrials Clinical Research Site (CRS), Instituto de Pesquisa Clinica Evandro Chagas (IPEC CRS), has created an extensive record of accomplishment in conducting clinical research at a hospital-based setting and has continuously proven to be an elite performer CRS. The IPEC CRS is committed to ensuring that all of its processes and standards meet or supersede the requirements for DAIDS-sponsored networks, ICH/GCP standards, and other regulatory authorities. The CRS has not only contributed to the generation of results that led to improved care and treatment for those infected with and affected by HIV, tuberculosis, and hepatitis and their associated comorbidities, but also to the licensure applications for 11 novel agents. The FioTrials CTU and the IPEC CRS have successfully undergone regulatory inspections from both US (FDA) and European (EMA) authorities. FioTrials and the IPEC CRS have established a solid relationship with the local HIV/AIDS and LGBTQI+ communities. Our program success is the result of a dynamic and collaborative process with different stakeholders, such as study participants and communities, community leaders and advocates, nongovernmental organizations, researchers, relevant governmental bodies, and health care providers. The CTU and CRS teams are composed of individuals and researchers with diverse social and professional backgrounds, gender, sexual orientation, race, beliefs, and values that well represent the communities we serve. During this next funding cycle, we look forward to the opportunity to contributing to the scientific and functional goals of the ACTG, HPTN, and HVTN networks. Together with our DAIDS Network partners, we aim to enhance the landscape for HIV, TB, and Hepatitis treatment and prevention.

FioTrials 摘要 FioTrials CTU 位于 Oswaldo Cruz 基金会 - FIOCRUZ（巴西里约热内卢），由 Dr. FioTrials 领导。 Beatriz Grinsztejn 并得到了一批经验丰富的研究人员和有前途的初级研究人员的支持。 FioTrials 隶属于 FIOCRUZ，FIOCRUZ 是公共卫生领域的国际卓越中心 传染病。 FioTrials CTU 促进和奖励创新，同时提供标准化、 临床试验实施和管理的正式方法。 CTU 已成功 为多个 NIH 赞助的网络实施并进行了关键的临床试验，这些试验改变了 过去 14 年的艾滋病毒和结核病 (TB) 预防和治疗情况。菲奥审判 临床研究中心 (CRS)、Instituto de Pesquisa Clinica Evandro Chagas (IPEC CRS) 创建了一个 在医院环境中进行临床研究方面取得了广泛的成就，并拥有 不断被证明是 CRS 的精英表演者。 IPEC CRS 致力于确保其所有 流程和标准满足或取代 DAIDS 赞助网络、ICH/GCP 的要求 标准和其他监管机构。 CRS 不仅有助于产生以下结果： 改善了对艾滋病毒、结核病和肝炎感染者和受影响者的护理和治疗， 其相关的合并症，还涉及 11 种新型药物的许可申请。 FioTrials CTU IPEC CRS已成功通过美国（FDA）和欧洲监管机构检查 （EMA）当局。 FioTrials 和 IPEC CRS 与当地艾滋病防治机构建立了牢固的关系 和 LGBTQI+ 社区。我们的计划的成功是与以下人员动态协作过程的结果 不同的利益相关者，例如研究参与者和社区、社区领袖和倡导者， 非政府组织、研究人员、相关政府机构和卫生保健提供者。这 CTU 和 CRS 团队由具有不同社会和专业背景的个人和研究人员组成 充分代表我们所在社区的背景、性别、性取向、种族、信仰和价值观 服务。在下一个资助周期中，我们期待有机会为科学和技术做出贡献 ACTG、HPTN 和 HVTN 网络的功能目标。与我们的 DAIDS 网络合作伙伴一起，我们的目标是 改善艾滋病毒、结核病和肝炎的治疗和预防状况。