Patient-relevance of outcome measures in breast cancer clinical trials - Data Files

The primary research question for which these data have been used, was: ‘How patient-relevant are outcomes measured in clinical trials for breast cancer drugs?’. Subquestions were: 1. Which treatment outcomes are relevant for breast cancer patients? 2. Which outcome measures are used in clinical trials for breast cancer drugs? 3. How much overlap is there between patient-relevant outcomes and outcomes measured in clinical trials?The dataset has been used to answer subquestion 2. Data have been obtained by searching Clinicaltrials.gov for trials conducted between January 2014 and March 2024 inclusive. Further inclusion criteria were that studies had to be phase III trials and had to focus on breast cancer, adults (18-64 years old) and drugs. Interventions focusing on lifestyle changes, Chinese medicine, anaesthesia, surgery and diagnostic methods were excluded. Ultimately, 264 trials were included and forty-five excluded. To determine the outcome measures used, the study plan of every included trial was reviewed and recorded on the data sheet.本数据集所支撑的核心研究问题为：“乳腺癌药物临床试验中所测量的结局指标，与患者的相关性如何？”。附属研究问题包括：1. 哪些治疗结局与乳腺癌患者相关？2. 乳腺癌药物临床试验中采用了哪些结局指标？3. 患者相关结局与临床试验所测量的结局之间的重合度如何？ 本数据集被用于解答上述第2个附属研究问题。研究数据通过检索临床试验注册平台ClinicalTrials.gov获取，检索范围为2014年1月至2024年3月（含首尾月份）开展的临床试验。进一步的纳入标准为：研究需为针对乳腺癌、成年人群（18-64岁）及药物的III期临床试验。排除以生活方式干预、中医药、麻醉、外科手术及诊断方法为干预手段的研究。最终纳入264项临床试验，排除45项。为明确所采用的结局指标，本研究对每一项纳入试验的研究方案进行了审阅，并将相关信息记录于数据表中。