Table 5 Barriers to use of routinely collected health data and potential solutions
Barrier | Example/explanation | Potential solution |
|---|---|---|
Lack of comprehensive list of RCHD sources and the data they hold | There 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 registries | The 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 RCHD | Shown by a small percentage of trials using RCHD | More publicity on available RCHD and the use of RCHD |
Poor accessibility of data | Registry 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 sharing | Time 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 timeliness | Trial 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 RCHD | Trial 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. |