获取常规收集的临床试验健康数据 - 对英国注册机构成功的数据请求进行审查。

Access to routinely collected health data for clinical trials - review of successful data requests to UK registries.

机构信息

MRC Clinical Trials Unit at UCL, Health Data Research, London, WC1V 6LJ, UK.

Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, L69 3BX, UK.

出版信息

Trials. 2020 May 12;21(1):398. doi: 10.1186/s13063-020-04329-8.

DOI:10.1186/s13063-020-04329-8

PMID:32398093

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7218527/

Abstract

BACKGROUND

Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.

METHODS

We conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013 and 2018 for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction were undertaken between January and May 2019.

RESULTS

We identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (about 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.

CONCLUSIONS

In the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined-up thinking between the registries and the regulatory authorities.

TRIAL REGISTRATION

PROSPERO CRD42019123088.

摘要

背景

尽管常规收集的健康数据（RCHD）在质量和广度上都有所提高，但临床试验通常各自收集自己的数据。我们的目的是量化英国的随机对照试验（RCT）获取 RCHD 以获取参与者数据，描述这些数据的使用方式，并据此推荐更多的试验可以如何使用 RCHD。

方法

我们对 2013 年至 2018 年间至少从英国一个注册处获取 RCHD 以提供或补充参与者数据的 RCT 进行了系统回顾。编制了一份英国持有 RCHD 的所有注册处的清单。在注册处发布释放登记册的情况下，对这些登记册进行了检索，以查找获取 RCHD 的 RCT。如果没有可用的发布登记簿，则联系注册处请求列出 RCT。对于每个确定的 RCT，都从所有公开来源（发布登记簿、网站、方案等）收集信息。搜索和数据提取于 2019 年 1 月至 5 月进行。

结果

我们从 22 个注册处中确定了 2013 年至 2018 年间的 160 项获取 RCHD 的 RCT；这仅相当于英国所有 RCT 的一小部分（约 3%）。获取 RCHD 的 RCT 通常规模较大（中位数样本量为 1590），常用于评估癌症或心血管疾病的治疗方法。大多数纳入的 RCT 从 NHS Digital 获取 RCHD（68%），最常获取的数据集是死亡率（76%）和医院就诊次数（55%）。RCHD 用于为主要试验（82%）和长期随访（57%）提供信息。RCT 使用 RCHD 为参与者的结果测量提供信息的方式存在很大差异。一个限制是注册处和 RCT 缺乏有关已访问哪些数据集以及出于什么目的访问的信息和透明度。