The Blurring of Treatment and Research in Clinical Trials: two problems

临床试验中治疗和研究的模糊：两个问题

• 批准号: 7814771
• 负责人: Charles W Lidz
• 金额: $ 49.19万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7814771
• 关键词: Accounting; Adherence; Area; Bioethics; Caring; Clinical; Clinical Research; Clinical Trials; Clinical trial protocol document; Code; Commit; Conflict (Psychology); Confusion; Consent; Data; Decision Making; Double-Blind Method; Ethical Issues; Ethicists; Event; Experimental Designs; Failure; Frequencies; Goals; Hand; Individual; Informed Consent; Intervention; Interview; Judgment; Knowledge; Measures; Medical; Medical Research; Mind; Morals; Paper; Participant; Patients; Personal Satisfaction; Pharmaceutical Preparations; Phase III Clinical Trials; Physicians; Placebos; Play; Principal Investigator; Procedures; Process; Protocols documentation; Public Health; Publishing; Randomized; Relative (related person); Reporting; Research; Research Ethics Committees; Research Personnel; Research Project Grants; Resources; Respondent; Risk; Sampling; Self Care; Site; Structure; Study Subject; Surveys; Symptoms; Testing; Treatment Protocols; Variant; base; clinical care; improved; interest; outer surface lipoprotein; research study; response; standard measure; standardize measure; success; therapeutic misconception

DESCRIPTION (provided by applicant): Challenge Area: Bioethics Challenge Topic: 02-OD(OSP)-105. Ethical Issues Raised by the Blurring between Treatment and Research. Project Title: The Blurring of Treatment and Research in Clinical Trials: Two problems. The blurring of the distinction between treatment and research in the minds of participants in phase 3 clinical trials has been referred to as therapeutic misconception (TM). This has been widely recognized as a major problem for informed consent to research. Subjects often have trouble understanding the distinction between the goals of research and the goals of treatment as well as the implications for their own treatment of participating in research. However, efforts to study TM are greatly hampered by the lack of a valid, reliable, and easily administered measure. Less widely recognized is a related phenomenon that clinical researchers are also caught between the two principles and tend to blur the distinction themselves. This is not so much a failure to understand as it is a moral or normative conflict. In a recent survey we found ample evidence that clinical researchers feel strongly committed to their "patients" and report breaking protocol in order to provide optimal clinical care. However, the survey data is limited in that we do not know enough about the specifics of the deviations from the protocols and how these deviations were handled by the researchers. The proposed study will make major strides in developing the understanding of both of these important examples of the blurring of treatment and research. The first aim of the study is to develop a robust, yet usable and easily scored, measure of TM. We will use both a proposed measure and a semi-structured interview to assess TM in 300 subjects in 60 different protocols at 4 different sites. The semi-structured interview with its associated coding rules has been used in prior research by the principal investigator to measure TM and will serve as a criterion for assessing the validity of the structured measure. We will also interview in depth the clinical researchers who provide the day-to-day clinical care in the same 60 protocols about their responses to the same survey that was reported in a recent paper. The goal here is to assess whether these deviations from the protocols would have serious consequences for the validity of the trials and whether they were appropriately reported so that the deviations can be taken into account in the analysis of the results of the study. In the process we will explore the perspective of clinical researchers about clinical care in clinical trials and assess whether they have a form of TM themselves. Public Health Significance: Maintaining the boundary between treatment and research in phase 3 clinical trials is a serious public health matter. Subjects' confusion of the two risks undermine the validity of their informed consent. If they think that research is no different from treatment they will seriously misunderstand to what they are consenting. Equally serious, if clinical researchers fail to maintain that boundary between research and treatment, they may make decisions in the interests of their "patients" that violate the protocol and thus threaten the validity of the research.

描述（由申请人提供）：挑战领域：生物伦理挑战主题：02-OD（OSP）-105。 治疗和研究之间的模糊所引起的伦理问题。临床试验中治疗和研究的模糊：两个问题。 在3期临床试验中，参与者心中治疗和研究之间的区别模糊不清，这被称为治疗误解（TM）。这已被广泛认为是知情同意研究的一个主要问题。受试者往往难以理解研究目标和治疗目标之间的区别，以及参与研究对他们自己治疗的影响。然而，TM研究的努力受到了很大的阻碍，缺乏一个有效的，可靠的，易于管理的措施。一个不太被广泛认识的相关现象是，临床研究人员也被夹在这两个原则之间，往往模糊了两者的区别。与其说这是一种不理解，不如说这是一种道德或规范上的冲突。在最近的一项调查中，我们发现了充分的证据表明，临床研究人员对他们的“病人”有强烈的承诺，并报告违反协议，以提供最佳的临床护理。然而，调查数据是有限的，因为我们不太了解方案偏离的具体情况以及研究人员如何处理这些偏离。这项拟议中的研究将在发展对这两个模糊治疗和研究的重要例子的理解方面取得重大进展。这项研究的第一个目的是开发一个强大的，但可用的和容易得分，TM的措施。我们将使用一个建议的措施和半结构化的采访，以评估TM在300名受试者在60个不同的协议在4个不同的网站。半结构化访谈及其相关的编码规则已被用于先前的研究中，由主要研究者测量TM，并将作为评估结构化措施的有效性的标准。我们还将深入采访在相同的60个协议中提供日常临床护理的临床研究人员，了解他们对最近一篇论文中报道的同一调查的反应。此处的目标是评估这些方案偏离是否会对试验有效性产生严重后果，以及是否适当报告了这些偏离，以便在分析研究结果时考虑这些偏离。在这个过程中，我们将探讨临床研究人员对临床试验中的临床护理的看法，并评估他们自己是否有一种TM形式。 公共卫生意义：在3期临床试验中保持治疗和研究之间的界限是一个严重的公共卫生问题。 受试者对这两种风险的混淆破坏了其知情同意的有效性。如果他们认为研究与治疗没有什么不同，他们就会严重误解他们所同意的。同样严重的是，如果临床研究人员不能保持研究和治疗之间的界限，他们可能会做出违反协议的决定，从而威胁到研究的有效性。