PDF(Pubmed)
Abstract：
UNASSIGNED: Standardized, high-quality PRO data reporting is crucial for patient centered care in the field of oncology, especially in clinical trials that establish standard of care. This study evaluated PRO endpoint design, conduct and reporting methods in FDA approved drugs for GU malignancies.
UNASSIGNED: A systematic review of the FDA archives identified GU cancer drug approvals from Feb 2007 to July 2022. ClinicalTrials.gov and PubMed were used to retrieve relevant data. PRO data was screened, and analytic tools, interpretation methods in the published papers and study protocols were reviewed. Compliance with PRO reporting standards were assessed using PRO Endpoint Analysis Score (PROEAS), a 24-point scoring scale from Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL).
UNASSIGNED: We assessed 40 trial protocols with 27,011 participants, resulting in 14 renal cell cancer (RCC), 16 prostate cancer (PC), and 10 urothelial cancer (UC) approvals. PRO data was published for 27 trials, with 23 PRO publications (85%) focusing solely on PRO data, while 4 (15%) included PRO data in the original paper. Median time between primary clinical and secondary paper with PRO data was 10.5 months (range: 9-25 months). PROs were not planned as primary endpoints for any study but 14 (52%) reported them as secondary, 10 (37%) as exploratory outcomes, and 3 (11%) lacked any clarity on PRO data as endpoint. Mean PROEAS score of all GU cancers was 11.10 (range: 6-15), RCC (11.86, range: 6-15), UC (11.50, range: 9-14), and PC (10.56, range: 6-15). None met all the SISAQOL recommendations.
UNASSIGNED: Low overall PROEAS score and delays in PRO data publication in GU cancer drug trials conducted in the past decade emphasize the need for improvement in quality of design and conduct of PRO endpoint in future trials and accelerated publication of PRO endpoints, using standardized analysis, and prespecified hypothesis driven endpoint. These improvements are essential for facilitating interpretation and application of PRO study findings to define patient care.
UNASSIGNED: None.
UNASSIGNED: A systematic review of the FDA archives identified GU cancer drug approvals from Feb 2007 to July 2022. ClinicalTrials.gov and PubMed were used to retrieve relevant data. PRO data was screened, and analytic tools, interpretation methods in the published papers and study protocols were reviewed. Compliance with PRO reporting standards were assessed using PRO Endpoint Analysis Score (PROEAS), a 24-point scoring scale from Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL).
UNASSIGNED: We assessed 40 trial protocols with 27,011 participants, resulting in 14 renal cell cancer (RCC), 16 prostate cancer (PC), and 10 urothelial cancer (UC) approvals. PRO data was published for 27 trials, with 23 PRO publications (85%) focusing solely on PRO data, while 4 (15%) included PRO data in the original paper. Median time between primary clinical and secondary paper with PRO data was 10.5 months (range: 9-25 months). PROs were not planned as primary endpoints for any study but 14 (52%) reported them as secondary, 10 (37%) as exploratory outcomes, and 3 (11%) lacked any clarity on PRO data as endpoint. Mean PROEAS score of all GU cancers was 11.10 (range: 6-15), RCC (11.86, range: 6-15), UC (11.50, range: 9-14), and PC (10.56, range: 6-15). None met all the SISAQOL recommendations.
UNASSIGNED: Low overall PROEAS score and delays in PRO data publication in GU cancer drug trials conducted in the past decade emphasize the need for improvement in quality of design and conduct of PRO endpoint in future trials and accelerated publication of PRO endpoints, using standardized analysis, and prespecified hypothesis driven endpoint. These improvements are essential for facilitating interpretation and application of PRO study findings to define patient care.
UNASSIGNED: None.
摘要：
■标准化，高质量的PRO数据报告对于肿瘤学领域以患者为中心的护理至关重要，尤其是在建立护理标准的临床试验中。本研究评估了PRO终点设计，FDA批准的GU恶性肿瘤药物的实施和报告方法。
■对FDA档案的系统审查确定了2007年2月至2022年7月的GU癌症药物批准。使用ClinicalTrials.gov和PubMed检索相关数据。PRO数据进行了筛选，和分析工具，对发表的论文和研究方案中的解释方法进行了综述。使用PRO终点分析评分(PROEAS)评估PRO报告标准的合规性，来自制定国际标准分析患者报告结果和生活质量终点数据联盟(SISAQOL)的24分评分表。
■我们评估了27,011名参与者的40项试验方案，导致14例肾细胞癌（RCC），16前列腺癌（PC），和10个尿路上皮癌（UC）批准。PRO数据公布了27项试验，有23份PRO出版物(85%)只关注PRO数据，而4(15%)在原始论文中包含PRO数据。具有PRO数据的主要临床论文和次要论文之间的中位时间为10.5个月（范围：9-25个月）。没有计划将PROs作为任何研究的主要终点，但14（52％）将其报告为次要终点，10（37%）作为探索性结果，3(11%)缺乏作为终点的PRO数据的清晰度。所有GU癌症的平均PROEAS评分为11.10（范围：6-15），RCC（11.86，范围：6-15），UC（11.50，范围：9-14），和PC（10.56，范围：6-15）。没有人符合SISAQOL的所有建议。
在过去十年中进行的GU癌症药物试验中，PROEAS总体得分低和PRO数据发布延迟，强调了在未来试验中需要改进PRO终点的设计和实施质量，并加快PRO终点的发布。使用标准化分析，和预先指定的假设驱动终点。这些改进对于促进PRO研究结果的解释和应用以定义患者护理至关重要。
■无。
■对FDA档案的系统审查确定了2007年2月至2022年7月的GU癌症药物批准。使用ClinicalTrials.gov和PubMed检索相关数据。PRO数据进行了筛选，和分析工具，对发表的论文和研究方案中的解释方法进行了综述。使用PRO终点分析评分(PROEAS)评估PRO报告标准的合规性，来自制定国际标准分析患者报告结果和生活质量终点数据联盟(SISAQOL)的24分评分表。
■我们评估了27,011名参与者的40项试验方案，导致14例肾细胞癌（RCC），16前列腺癌（PC），和10个尿路上皮癌（UC）批准。PRO数据公布了27项试验，有23份PRO出版物(85%)只关注PRO数据，而4(15%)在原始论文中包含PRO数据。具有PRO数据的主要临床论文和次要论文之间的中位时间为10.5个月（范围：9-25个月）。没有计划将PROs作为任何研究的主要终点，但14（52％）将其报告为次要终点，10（37%）作为探索性结果，3(11%)缺乏作为终点的PRO数据的清晰度。所有GU癌症的平均PROEAS评分为11.10（范围：6-15），RCC（11.86，范围：6-15），UC（11.50，范围：9-14），和PC（10.56，范围：6-15）。没有人符合SISAQOL的所有建议。
在过去十年中进行的GU癌症药物试验中，PROEAS总体得分低和PRO数据发布延迟，强调了在未来试验中需要改进PRO终点的设计和实施质量，并加快PRO终点的发布。使用标准化分析，和预先指定的假设驱动终点。这些改进对于促进PRO研究结果的解释和应用以定义患者护理至关重要。
■无。
