Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
Semin Radiat Oncol. 2019 Oct;29(4):318-322. doi: 10.1016/j.semradonc.2019.05.004.
Randomized control trials (RCTs) represent the gold standard by which new therapies are evaluated. However, there are many limitations to RCTs including biased populations enrolled and potential lack of generalizability. This has resulted in increasing interest in data that represent real world patients, who are not well represented in RCTs. These real world data (RWD) have the potential to provide data not captured in clinical trials such as longer term outcomes, sequelae and adverse events not identified in the sample size used for the RCT. There are many sources of RWD, all of which have strengths and limitations. This manuscript focuses on one source of RWD - the cancer registry. Cancer registries represent a set of consolidated data which are collected under state regulation in each state. As cancer surveillance expands the type and level of detail captured within registries, the potential value for complementing and supplementing clinical trials is increasing.
随机对照试验 (RCT) 是评估新疗法的金标准。然而，RCT 存在许多局限性，包括入组人群存在偏倚和潜在的缺乏普遍性。这导致人们对代表真实世界患者的数据越来越感兴趣，而这些患者在 RCT 中代表性不足。这些真实世界数据 (RWD) 有可能提供临床试验中未捕获到的数据，例如 RCT 中使用的样本量未识别的长期结局、后遗症和不良事件。RWD 有许多来源，各有优缺点。本文重点介绍 RWD 的一个来源——癌症登记处。癌症登记处代表一组在各州监管下收集的整合数据。随着癌症监测的扩展，登记处中捕获的类型和详细程度也在增加，因此为补充临床试验提供的潜在价值也在增加。
