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Table 5 Barriers to use of routinely collected health data and potential solutions

From: Access to routinely collected health data for clinical trials – review of successful data requests to UK registries

BarrierExample/explanationPotential solution
Lack of comprehensive list of RCHD sources and the data they holdThere is no one point where you can find out about all sources of RCHD.A searchable database – HDR UK or NHS Digital is responsible for update.
Clear terminology to describe data from registriesThe source of the trial data is not always mentioned in trial publications.Publication of consensus terminology and a description of the way in which RCHD can be used.
Publications of trials using RCHD did not make mention of it.In methods section, details of the sources of RCHD should be stated.Soon-to-be-released EHR CONSORT extension for routinely collected health data should improve this.
Lack of awareness by trialists of the availability and utility of RCHDShown by a small percentage of trials using RCHDMore publicity on available RCHD and the use of RCHD
Poor accessibility of dataRegistry name change invalidating consent
Long delays of several years in application process
RCHD not provided despite agreement
Streamline the RCHD application process and render it efficient.
Poor data retention and no possibility of onward sharingTime limit to keeping the data is shorter than the data storage time limit for the trial.
Data sharing is often necessary to achieve funding for a trial.
RCHD needs to align with trial data retention rules and data-sharing requirements.
Data quality and timelinessTrial data are monitored and checked and a lot of registry data are not.Registry data need a validation process to ensure that their RCHD can be used as a verifiable GCP-compliant data source.
A comparison of trial and registry data in several trials, facilitated by a SWAT, is required to educate all about the accuracy and completeness of registry data.
Regulator ready RCHDTrial data require underlying source data whilst registry data are not source data and do not often have checked underlying source data.Regulators and registries need to agree a solution to underlying source data.
  1. Abbreviations: EHR CONSORT electronic health record Consolidated Standards of Reporting Trials, GCP Good Clinical Practice, HDR UK Health Data Research UK, NHS National Health Service, RCHD routinely collected health data, RCT randomised controlled trial, SWAT study-within-a-trial