Accountability and the Role of the Principal Investigator in Multicenter Trials

描述（由申请人提供）：制药，生物技术和设备行业资助大多数临床试验。然而，这类试验的责任是令人担忧的问题，部分原因是有证据表明，这类试验往往有利于该公司的产品，担心不良事件的漏报，以及最近披露的代笔。对行业赞助的研究进行问责的一个主要机制是学术首席研究员（PI）的存在，期刊，临床医生和公众将其视为试验的担保人。然而，没有关于专业人员发挥的作用或他们对重大任务和决策的控制程度的数据。因此，很难知道是否有理由将PI视为其试验的监督者。此外，没有关于PI作用的详细公布标准。本提案的目的是：1）根据主要利益相关者的观点，阐明多中心随机对照试验（RCT）中总体PI应发挥作用的详细规范性概念; 2）描述在主要期刊上发表的多中心RCT的PI对PI适当角色和职责的态度; 3）描述PI在特定试验中发挥的实际作用; 4）检验行业申办的多中心RCT中PI与非行业申办的试验中PI发挥不同作用的假设。为了实现这些目标，我们将与不同利益相关者群体的代表（NIH临床研究负责人;临床试验合作小组和网络主席; PI;行业临床研究负责人;期刊编辑; FDA官员）进行6次德尔菲小组讨论。在这些小组之后，将对在主要的普通、肿瘤学、心血管和精神病学期刊上发表的多中心RCT的PI进行平行调查，以评估他们对PI角色的规范观点（调查1）和他们作为PI的实际实践（调查2）。考虑到关键利益相关者群体的观点，这些小组和调查将首次详细描述多中心试验中总体PI的职责和期望。此外，他们还将提供关于PI在各种试验中的实际角色和责任的数据，为临床研究中PI问责制的问题提供第一个系统性答案。 公共卫生相关性：本提案所解决的问题对医学和公共卫生具有深远的影响。通过医生、患者和监管机构的决定，多中心试验对医学产生了重大影响。鉴于这些审判的根本重要性，必须确认目前保障这些审判的道德和公正的机制。这项提案的结果将再次肯定对这些试验的信任，或者将促进临床研究问责制的发展

DESCRIPTION (provided by applicant): The pharmaceutical, biotechnology and device industries fund most clinical trials. However, accountability in such trials is the subject of concern, due in part to evidence that such trials tend to favor the company's product, to worries about underreporting of adverse events, and to recent disclosures about ghostwriting. One major mechanism of accountability for industry-sponsored research is the presence of an academic Principal Investigator (PI), whom journals, clinicians and the public view as the trial's guarantor. However, no data are available regarding the roles that PIs play or the degree of control they exercise over major tasks and decisions. Consequently, it is difficult to know whether it is reasonable to view PIs as guarantors of their trials. Furthermore, there are no detailed published standards regarding the PI's role. The Aims of the present proposal are: 1) to articulate a detailed normative conception, based on major stakeholders' views, of the roles that overall PIs in multicenter randomized controlled trials (RCTs) should play; 2) to describe attitudes among PIs of multicenter RCTs published in major journals towards the appropriate roles and responsibilities of the PI; 3) to describe the actual roles that PIs played in particular trials; and 4) to test the hypothesis that PIs in industry-sponsored multicenter RCTs play different roles than do PIs in non-industry sponsored trials. To achieve these Aims, we will conduct 6 Delphi panels with representatives of diverse stakeholder groups (NIH clinical research leaders; clinical trial cooperative-group and network chairs; PIs; industry clinical research leaders; journal editors; FDA officials). These panels will be followed by parallel surveys of PIs of multicenter RCTs published in major general, oncology, cardiovascular and psychiatry journals to assess both their normative views of the PI role (survey 1) and their actual practices as PIs (survey 2). These panels and surveys will provide the first detailed description, taking into account the views of key stakeholder groups, of the responsibilities and expectations of overall PIs in multicenter trials. In addition, they will provide data regarding the actual roles and responsibilities of PIs in a diverse set of trials, providing the first systematic answers to questions about PI accountability in clinical research. PUBLIC HEALTH RELEVANCE: The questions addressed by the present proposal have profound implications for medicine and public health. Through decisions by physicians, patients and regulators, multicenter trials have a major impact on medicine. Given their fundamental importance, it is essential to validate the current mechanisms for guaranteeing the ethics and integrity of these trials. The findings of this proposal will either reaffirm trust in these trials, or will stimulate the development of enhanced systems of accountability for clinical research