Dhruva Sanket S, Kesselheim Aaron S, Woloshin Steven, Ji Robin Z, Lu Zhigang, Darrow Jonathan J, Redberg Rita F
University of California, San Francisco School of Medicine, San Francisco, CA, USA.
Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, CA, USA.
Med Decis Making. 2025 Feb;45(2):156-167. doi: 10.1177/0272989X241302096. Epub 2024 Dec 21.
After a new drug or medical device is approved by the US Food and Drug Administration (FDA), physician-patient communication about benefits and risks is critical, including whether the product was approved through an expedited pathway based on limited evidence. In addition, physician reporting of drug- and device-related adverse events in real-world use is necessary to have a complete safety profile. We studied physician-reported communication and safety-reporting practices related to drugs and devices.
We surveyed a random national sample of American Board of Internal Medicine-certified internists, cardiologists, and oncologists between October 2021 and September 2022 about the sources of information used to prescribe a drug or medical device, details of communication with patients, and reporting of adverse events.
Among 509 respondents (39% response rate), 387 (76%) reported that FDA approval influenced their decision "a lot" to prescribe a new drug or recommend use of a medical device. Half (122; 50%) of the 244 physicians randomized to receive a question about their own communication of trial endpoints reported "usually" telling patients when products were approved based on surrogate measures and 126 (52%) "usually" reported telling patients if a postapproval trial was required to evaluate safety and effectiveness. Two-thirds (165) said they were likely to report drug- or device-related adverse events to FDA.
Physician self-reporting of communication with patients about drugs and devices suggests that half include characteristics of the pivotal trials such as use of clinically meaningful endpoints or continued requirement for evidence generation.
More consistent discussions with patients about the quality of evidence supporting new drugs and devices and increased reporting of adverse events could ensure optimal use of these products in clinical practice.
Among 509 board-certified internists, cardiologists, and oncologists, half reported telling patients when drugs or medical devices were approved based on surrogate measures and when there was an FDA-mandated postapproval trial to further evaluate safety and effectiveness.As drugs and medical devices are increasingly approved by the FDA through expedited pathways based on data with lingering uncertainties, discussion with patients about issues such as the nature of the endpoints assessed and existence of postapproval testing requirements can help inform patient decision making.
在美国食品药品监督管理局（FDA）批准一种新药或医疗器械后，医生与患者就其益处和风险进行沟通至关重要，包括该产品是否基于有限证据通过加速审批途径获得批准。此外，医生报告药物和器械在实际使用中与药物和器械相关的不良事件对于全面了解其安全性至关重要。我们研究了医生报告的与药物和器械相关的沟通及安全报告做法。
在2021年10月至2022年9月期间，我们对美国内科医学委员会认证的内科医生、心脏病专家和肿瘤学家进行了一项全国随机抽样调查，内容包括用于开处方药物或医疗器械的信息来源、与患者沟通的细节以及不良事件报告情况。
在509名受访者中（回复率为39%），387人（76%）报告称FDA的批准对他们开新药或推荐使用医疗器械的决定“有很大影响”。在随机接受关于自身对试验终点沟通问题调查的244名医生中，有一半（122人；50%）报告“通常”会告知患者产品是否基于替代指标获得批准，126人（52%）报告“通常”会告知患者是否需要进行批准后试验以评估安全性和有效性。三分之二（165人）表示他们可能会向FDA报告与药物或器械相关的不良事件。
医生关于与患者就药物和器械进行沟通的自我报告表明，有一半医生会提及关键试验的特征，如使用具有临床意义的终点或持续需要生成证据。
与患者就支持新药和器械的证据质量进行更一致的讨论，并增加不良事件报告，可确保这些产品在临床实践中的最佳使用。
在509名获得委员会认证的内科医生、心脏病专家和肿瘤学家中，有一半报告称会告知患者药物或医疗器械何时基于替代指标获得批准，以及何时有FDA强制要求的批准后试验以进一步评估安全性和有效性。随着FDA越来越多地基于存在不确定性的数据通过加速审批途径批准药物和医疗器械，与患者讨论诸如评估终点的性质以及批准后测试要求的存在等问题有助于为患者的决策提供信息。
