Exploring the Ethical Dimensions of Peanut Allergy Immunotherapy Research

探索花生过敏免疫治疗研究的伦理维度

• 批准号: 10308499
• 负责人: JILL A FISHER
• 金额: $ 19.44万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10308499
• 关键词: 1 year old; Accounting; Adult; Adverse reactions; Advocate; Affect; Allergen Immunotherapy; Allergens; Allergy to peanuts; Anaphylaxis; Area; Attention; Benefits and Risks; Bioethics; Biomedical Research; Caregivers; Child; Childhood; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Complex; Conduct Clinical Trials; Consent; Development; Dimensions; Emerging Technologies; Enrollment; Ensure; Environment; Epidemic; Ethical Issues; Ethics; Ethnography; Evaluation; Event; Exposure to; FDA approved; Family; Food Hypersensitivity; Future; Goals; Hearing; Hypersensitivity; Immune system; Immunotherapy; Individual; Ingestion; Interview; Legal; Life; Measures; Mind; Modality; Observational Study; Oral; Outcome; Patient advocacy; Patients; Pediatric Research; Pharmacologic Substance; Population; Powder dose form; Prevalence; Principle-Based Ethics; Product Approvals; Protocols documentation; Public Health; Reaction; Recommendation; Research; Research Design; Research Personnel; Research Priority; Risk; Sales; Serious Adverse Event; Shapes; Social Sciences; Structure; Therapeutic; Thinking; Treatment Efficacy; United States; United States National Institutes of Health; adolescent patient; analytical method; clinical practice; desensitization; design; financial conflict of interest; food challenge; immunotherapy clinical trials; improved; innovation; interest; new technology; novel; novel therapeutics; product development; research and development; response; subcutaneous; symposium; technology development; willingness

PROJECT SUMMARY An important area of pediatric research and development is peanut allergy immunotherapy. Researchers are pursuing oral, sublingual, subcutaneous, and epicutaneous products that activate the immune system through allergen exposure to desensitize individuals to peanuts. One such treatment is now FDA approved, and another is poised to receive market approval. However, immunotherapy conveys significant risk to patients, such as high rates of treatment-induced anaphylaxis. This project's objective is to identify empirically the on-the-ground ethical challenges that emerge in pediatric peanut immunotherapy (PIT) clinical trials. To date, there has been little attention to ethics within the broad domain of food allergy research and practice. Yet, PIT research involves many features that warrant ethical consideration, including clinical trials that enroll children, some as young as 1 year old, and risk-benefit profiles that differ from many other therapeutic areas. To explore these ethical issues, the project has 2 specific aims: (1) Document how stakeholders—investigators, caregivers, adolescents, patient advocates, FDA officers, and pharmaceutical company representatives—define and understand acceptable risks and benefits from peanut immunotherapy, both in terms of research protocols and the eventual products to be used in clinical practice; and (2) Identify the ethical challenges that emerge from these stakeholders' stances on peanut immunotherapy risks and benefits. For Aim 1, the project uses an ethnographic approach—consisting of observational studies and 125 semi-structured interviews—that focuses on 6 leading U.S. PIT research centers, academic food allergy conferences, patient advocacy events, and FDA hearings for PIT products. To accomplish Aim 2, the project employs analytic methods to ground the empirical findings from Aim 1 in bioethical frameworks, including principlism and research on vulnerable or complex populations. The proposed research is significant because it will develop an initial framework for the ethical conduct of PIT clinical trials that attends to the myriad interests that drive biomedical research, including the search for therapies that meaningfully improve the lives of children and adults with peanut allergy, the need to design and conduct clinical trials to meet the regulatory standards required by the FDA for the approval of products, and the commercial context in which investigators and companies have financial conflicts of interest that motivate the successful development of new therapies. This project is innovative because it explores a novel area of social science and bioethics research and because it investigates the entire sphere of PIT research and a wide array of stakeholders. This application is directly responsive to NIH's Notice of Interest in High Priority Research in Bioethical, Legal, and Societal Implications of Biomedical Research (NOT-LM-17-001), focusing in particular on new and emerging technology development and use, pediatric research, and the current and emerging regulatory environments.

项目概要 儿科研究和开发的一个重要领域是花生过敏免疫疗法。 追求口服、舌下、皮下和表皮产品，通过以下方式激活免疫系统： 过敏原暴露使个体对花生脱敏，目前 FDA 批准了一种治疗方法，另一种治疗方法已获得 FDA 批准。 即将获得市场批准然而，免疫疗法给患者带来了重大风险，例如高风险。 该项目的目标是根据经验确定实际的伦理问题。 迄今为止，儿科花生免疫疗法（PIT）临床试验中出现的挑战还很少。 然而，PIT 研究涉及广泛的食物过敏研究和实践领域的道德规范。 许多特征值得伦理考虑，包括招募儿童的临床试验，其中一些年龄只有 已有 1 年历史，且风险效益概况与许多其他治疗领域不​​同。为了探讨这些伦理问题， 该项目有 2 个具体目标：(1) 记录利益相关者——研究人员、护理人员、青少年、患者如何 倡导者、FDA 官员和制药公司代表——定义并理解可接受的风险 以及花生免疫疗法的益处，无论是在研究方案还是最终产品方面 用于临床实践；(2) 确定这些利益相关者的立场所带来的伦理挑战 对于目标 1，该项目采用了人种学方法，包括： 观察性研究和 125 次半结构化访谈——重点关注 6 个美国领先的 PIT 研究中心， 食物过敏学术会议、患者宣传活动和 FDA 针对 PIT 产品的听证会。 目标 2，该项目采用分析方法将目标 1 的实证结果建立在生物伦理框架中， 包括针对弱势或复杂人群的原则和研究。拟议的研究意义重大。 因为它将为 PIT 临床试验的道德行为制定一个初步框架，该试验涉及无数的 推动生物医学研究的兴趣，包括寻找能够有意义地改善人们生活的疗法 患有花生过敏的儿童和成人，需要设计和进行临床试验以满足监管要求 FDA 批准产品所需的标准，以及调查人员所处的商业环境 公司之间存在财务利益冲突，从而推动新疗法的成功开发。 该项目具有创新性，因为它探索了社会科学和生物伦理学研究的新领域，并且因为 它直接调查整个 PIT 研究领域和广泛的利益相关者。 响应 NIH 对生物伦理​​、法律和社会影响的高度优先研究的兴趣通知 生物医学研究 (NOT-LM-17-001)，特别关注新兴技术的开发 和使用、儿科研究以及当前和新兴的监管环境。