评估欧洲管制信息来源向患者和临床医生传达抗癌药物效益和相关不确定性的相关准确信息的频率。文件内容分析。欧洲药品局。欧洲药品局授权第一个营销授权的抗癌药物，2017-19。是否有关产品的书面信息回答了患者通常提出的问题，包括：药物用于谁和什么情况；如何进行药物研究；预计药物效益类型和缺乏效益证据的程度。将用于临床医生（产品特性摘要）、患者（患者信息单）和公众（公共摘要）的药物效益信息与监管评估文件（欧洲公共评估报告）中报告的信息进行比较。包括在2017-19年为32种不同癌症适应症授予第一个营销授权的29种抗癌药物。针对患者和临床医生的管制信息来源经常报告有关药物的一般信息（包括有关批准适应症的信息和药物的作用）。几乎所有的产品特性摘要向临床医生传达了有关主要研究数量和设计、对照组（如果有）、研究样本大小和药物效益的主要指标的全部信息。患者信息单没有向患者传达关于药物研究的信息。 31（97％）的产品特性摘要和25（78％）的公共摘要中包含准确并与监管评估文件中的信息一致的药物效益信息。在23个（72％）产品特性摘要和4个（13％）公共摘要中报告了药物能否延长生存的证据。患者信息单没有传达任何基于研究结果的药物效益信息。欧洲监管评估员针对研究样本中近所有药物提出的药物效益证据可靠性的科学担忧很少传达给临床医生、患者或公众。这项研究的发现强调了需要改善欧洲管制信息来源中抗癌药物效益和相关不确定性的传达，以支持患者和临床医生的证据决策。 ©作者（或其雇主）2019年。经CC BY允许再次使用。不得商业再利用。由BMJ出版。

To evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe.Document content analysis.European Medicines Agency.Anticancer drugs granted a first marketing authorisation by the European Medicines Agency, 2017-19.Whether written information on a product addressed patients' commonly asked questions about: who and what the drug is used for; how the drug was studied; types of drug benefit expected; and the extent of weak, uncertain, or missing evidence for drug benefits. Information on drug benefits in written sources for clinicians (summaries of product characteristics), patients (patient information leaflets), and the public (public summaries) was compared with information reported in regulatory assessment documents (European public assessment reports).29 anticancer drugs that received a first marketing authorisation for 32 separate cancer indications in 2017-19 were included. General information about the drug (including information on approved indications and how the drug works) was frequently reported across regulated information sources aimed at both clinicians and patients. Nearly all summaries of product characteristics communicated full information to clinicians about the number and design of the main studies, the control arm (if any), study sample size, and primary measures of drug benefit. None of the patient information leaflets communicated information to patients about how drugs were studied. 31 (97%) summaries of product characteristics and 25 (78%) public summaries contained information about drug benefits that was accurate and consistent with information in regulatory assessment documents. The presence or absence of evidence that a drug extended survival was reported in 23 (72%) summaries of product characteristics and four (13%) public summaries. None of the patient information leaflets communicated information about the drug benefits that patients might expect based on study findings. Scientific concerns about the reliability of evidence on drug benefits, which were raised by European regulatory assessors for almost all drugs in the study sample, were rarely communicated to clinicians, patients, or the public.The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.