Related Experiment Video

Updated: Nov 6, 2025

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

Methodology for Establishing a Community-Wide Life Laboratory for Capturing Unobtrusive and Continuous Remote Activity and Health Data

Published on: July 27, 2018

Accessing routinely collected health data to improve clinical trials: recent experience of access

Archie Macnair^1,2, Sharon B Love^3,4, Macey L Murray^3,4

¹MRC Clinical Trials Unit at UCL, UCL, London, WC1V 6LJ, UK. a.macnair@ucl.ac.uk.

|May 11, 2021

Abstract

Background:

Routinely collected electronic health records (EHRs) have the potential to enhance randomised controlled trials (RCTs) by facilitating recruitment and follow-up. Despite this, current EHR use is minimal in UK RCTs, in part due to ongoing concerns about the utility (reliability, completeness, accuracy) and accessibility of the data. The aim of this manuscript is to document the process, timelines and challenges of the application process to help improve the service both for the applicants and data holders.

Methods:

This is a qualitative paper providing a descriptive narrative from one UK clinical trials unit (MRC CTU at UCL) on the experience of two trial teams' application process to access data from three large English national datasets: National Cancer Registration and Analysis Service (NCRAS), National Institute for Cardiovascular Outcomes Research (NICOR) and NHS Digital to establish themes for discussion. The underpinning reason for applying for the data was to compare EHRs with data collected through case report forms in two RCTs, Add-Aspirin (ISRCTN 74358648) and PATCH (ISRCTN 70406718).

Results:

The Add-Aspirin trial, which had a pre-planned embedded sub-study to assess EHR, received data from NCRAS 13 months after the first application. In the PATCH trial, the decision to request data was made whilst the trial was recruiting. The study received data after 8 months from NICOR and 15 months for NHS Digital following final application submission. This concluded in May 2020. Prior to application submission, significant time and effort was needed particularly in relation to the PATCH trial where negotiations over consent and data linkage took many years.

Conclusions:

Our experience demonstrates that data access can be a prolonged and complex process. This is compounded if multiple data sources are required for the same project. This needs to be factored in when planning to use EHR within RCTs and is best considered prior to conception of the trial. Data holders and researchers are endeavouring to simplify and streamline the application process so that the potential of EHR can be realised for clinical trials.

Keywords:

Clinical trials Data accessibility Electronic health records Routinely collected data

More Related Videos

Generation of Comprehensive Thoracic Oncology Database - Tool for Translational Research

Generation of Comprehensive Thoracic Oncology Database - Tool for Translational Research

Published on: January 22, 2011

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Inverse Probability of Treatment Weighting Propensity Score using the Military Health System Data Repository and National Death Index

Published on: January 8, 2020

Related Concept Videos

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Data Collection I

Data Collection I

Data collection gathers information needed to make accurate judgments about a patient's present condition. During a health history interview, subjective data is collected from the patient, their caregivers, or family members, and objective data is collected through observations and physical assessment. Patients are the primary source of subjective data. Thus information gathered from patients through interviews, observations, and physical examination is primary data. Secondary sources of...

Data Collection by Experiments

Data Collection by Experiments

Data collection is a systematic method of obtaining, observing, measuring, and analyzing accurate information. An experimental study is a standard method of data collection that involves the manipulation of the samples by applying some form of treatment prior to data collection. It refers to manipulating one variable to determine its changes on another variable. The sample subjected to treatment is known as “experimental units.”
An example of the experimental method is a public...

Purpose of Health Records II

Purpose of Health Records II

Health records serve various essential purposes in the healthcare system. Here are some key purposes:

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

Articles linked to this work by shared authors, journal, and citation graph.

The role of DNA mismatch repair status in oesophagogastric cancer treated with perioperative chemotherapy: evidence from the MRC ST03 and OE05 trials.

British journal of cancer·2026

Decentralised Oncology Trials in the UK: Evidence, Regulation and Academic Clinical Trials Units' Perspectives.

BMJ oncology·2026

Walking the tightrope of justifiable decision‑making: An exploratory qualitative study identifying barriers and solutions to efficient safety reporting.

PloS one·2026

A comparison of missing data approaches for linear regression with missing not at random outcome and predictors.

Statistical methods in medical research·2026

Comparing risk factors in severe COVID-19 using machine learning and non-machine learning methods: analysis from 2 international randomized controlled trials.

JAMIA open·2026

Language-related eligibility criteria in UK randomised trials: a systematic review of extended research reports.

Trials·2026

See all related articles