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. Beatriz Grinsztejn和支持的干部经验丰富的研究人员和有前途的初级研究人员。 FioTrials隶属于FIOCRUZ，这是一个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。反恐组已经成功地 为多个NIH赞助的网络实施并进行了关键的临床试验，这些网络改变了 艾滋病毒和结核病（TB）的预防和治疗在过去14年的景观。FioTrials 临床研究中心（CRS），Instituto de Pesquisa Clinica Evandro Chagas（IPEC CRS），创建了一个 在医院开展临床研究方面有着广泛的成就记录， 不断被证明是一个精英表演CRS。IPEC CRS致力于确保其所有 流程和标准符合或取代DAIDS申办的网络、ICH/GCP的要求 标准和其他监管机构。CRS不仅有助于产生结果， 改善了对艾滋病毒、结核病和肝炎感染者的护理和治疗， 它们的相关合并症，而且还与11种新药的许可申请有关。反恐小组 IPEC CRS已成功通过美国（FDA）和欧洲（EU）的监管检查 (EMA)当局FioTrials和IPEC CRS与当地艾滋病毒/艾滋病防治机构建立了牢固的关系 LGBTQI+社区我们的计划成功是一个动态和协作过程的结果， 不同的利益相关者，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。的 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 背景，性别，性取向，种族，信仰和价值观，以及代表我们的社区， 发球。在下一个供资周期，我们期待着有机会为科学和 ACTG、HPTN和HVTN网络的功能目标。我们与DAIDS网络合作伙伴一起， 加强艾滋病毒、结核病和肝炎的治疗和预防。