Regulation of Clinical Research Related to HIV CURE

HIV 治疗相关临床研究的监管

• 批准号: 9482169
• 负责人: Veronica Miller
• 金额: $ 5.6万
• 依托单位: UNIVERSITY OF CALIFORNIA BERKELEY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-11-24 至 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9482169
• 关键词: Address; Advocate; Affect; Area; California; Clinical Research; Clinical Trials Design; Communication; Communities; Congresses; Consensus; Development; Disease; Disease remission; District of Columbia; Drug Industry; Ensure; Epidemic; Ethicists; Ethics; Future; HIV; Hearing; Hour; Industry; Interruption; Intervention; Investigation; Journals; Manuscripts; Outcome; Participant; Patients; Peer Review; Personal Satisfaction; Persons; Phase; Population; Process; Public Health Schools; Publications; Published Comment; Recommendation; Regulation; Reporting; Research; Research Personnel; Science; Scientist; Structure; Time; Translations; United States Food and Drug Administration; United States National Institutes of Health; Universities; Voice; Woman; base; college; design; expectation; experience; gene therapy; meetings; men; symposium; web page

PROJECT SUMMARY/ABSTRACT The Forum for Collaborative Research at the University of California Berkeley School of Public Health (the Forum) requests support to facilitate the development and regulatory approval of HIV curative strategies by addressing communication gaps among scientists, regulators, ethicists, patient community and industry. This Conference will create a neutral space, provide all stakeholders an equal voice, and allow extensive time for rich and fruitful conversations around treatment interruptions in HIV cure investigational interventions, the inclusion (or not) of specific populations in HIV cure studies, the specific concerns of gene therapy based research, and the ethical community engagement in HIV cure oriented studies. These discussions will help to generate consensus and recommendations to move the regulatory science of HIV cure research forward. This Conference will be a unique setting not available in other contexts; addressing HIV affected community concerns in a safe space, integrating these discussions into the regulatory context so that translation into outcome is more efficient, having academics and regulators hear the same message from community. It will be a space of dialogue where stakeholders will participate equally on the current and future wellbeing of people living with HIV and will discuss how research needs to be prioritized to meet the needs and concerns of the community, so that the community informs every phase of the research. The Forum will organize the “Regulation of Clinical Research Related to HIV Cure” conference, a one day 9- hour meeting consisting of six sessions (panels), five of which are a 60-minute topic-oriented, divided in 30 minutes for a presentation and panelists comments, and 30 minutes for open discussions. By the end of the day, a 20-minute session will be devoted to general discussion, conclusions, recommendations and next steps. The panels, facilitated by a moderator, will consist of a presenter expert on the topic of discussion, and 3 – 4 panelists that will include: a regulatory person, an ethicist and a community representative. Moderators will keep the sessions on time and moderate the open discussions, ensuring that these are conducted collegiately and respectfully. By the end of each session the moderator will elaborate conclusions and produce recommendations on the topic of discussion. The conference aims to have 80-100 participants that will include representatives from the US Food and Drug Administration (FDA), the US National Institutes of Health (NIH), investigators and academics, ethicists, people affected by the HIV epidemic, including people living with HIV, community advocates, pharmaceutical industry representatives and other stakeholders. The Forum and Planning Committee will produce a conference report that will be submitted to a peer reviewed journal for publication shortly after the meeting. The planning committee will develop a plan to produce manuscripts for publications and present recommendations at conferences based on meeting discussions.

项目总结/摘要 加州伯克利大学公共卫生学院合作研究论坛（The Forum for Collaborative Research at the University of California Berkeley School of Public Health） 论坛）要求支持促进艾滋病毒治疗战略的制定和监管批准， 解决科学家、监管机构、伦理学家、患者群体和行业之间的沟通差距。 这次会议将创造一个中立的空间，为所有利益攸关方提供平等的发言权，并留出大量时间。 关于艾滋病毒治愈研究干预措施中治疗中断的丰富和富有成效的对话， 包括（或不）特定人群的艾滋病毒治愈研究，基因治疗的具体问题， 研究，以及伦理社区参与艾滋病毒治疗导向的研究。这些讨论将有助于 产生共识和建议，推动艾滋病毒治疗研究的监管科学向前发展。 这次会议将是一个独特的背景下没有其他情况下;解决艾滋病毒影响的社区 在一个安全的空间，将这些讨论纳入监管背景下，使翻译成 结果是更有效的，让学者和监管机构听到来自社区的相同信息。它将 成为一个对话空间，利益攸关方将平等参与人民当前和未来的福祉 艾滋病毒感染者，并将讨论如何研究需要优先考虑，以满足需求和关注的 社区，以便社区通知研究的每个阶段。 该论坛将组织“与艾滋病毒治疗相关的临床研究的监管”会议，为期一天， 一个小时的会议，包括六个会议（小组），其中五个是一个60分钟的主题，分为30 发言和小组成员评论时间为30分钟，公开讨论时间为30分钟。结束时 在为期一天的会议上，将专门进行20分钟的一般性讨论、结论、建议和今后的步骤。 小组讨论由一名主持人主持，将由一名讨论专题的主讲人专家和3 - 4名 小组成员将包括：一名监管人员、一名伦理学家和一名社区代表。主持人将 按时举行会议，主持公开讨论，确保这些讨论在合议的情况下进行 而且很有礼貌在每次会议结束时，主持人将详细阐述结论， 关于讨论议题的建议。 会议的目标是有80-100名与会者，其中包括美国食品和药物管理局的代表。 美国食品药品监督管理局（FDA）、美国国立卫生研究院（NIH）、研究人员和学者、伦理学家、 受艾滋病毒流行影响的人，包括艾滋病毒感染者、社区倡导者、制药业 代表和其他利益攸关方。 论坛和规划委员会将编写一份会议报告，提交给同行审议。 会议结束后不久出版。计划委员会将制定一项计划， 根据会议讨论情况，在会议上提出建议。