"Real world" populations compared to clinical trials: can electronic record linkage be used to identify trial eligible patients?

The Cancer Medicines Outcomes Programme aims to develop a process to determine clinical outcome data of cancer medicines in Scotland using routinely collected, electronically linked health records. Such, ‘real world’ patient populations are not necessarily directly comparable to clinical trial populations suggesting that outcome data from clinical trials may not provide a suitable benchmark. It is therefore important to be able to describe the demographics of a population to contextualise outcome data.

The aim of this study was to determine whether electronic record linkage (ERL) could be used to evaluate the potential eligibility of patients for inclusion in a relevant clinical trial.

Although many eligibility criteria used in the clinical trials could be applied to ERL, others could not. Nevertheless, ERL can be used to estimate the number of patients being treated with a specific cancer medicine who may have been eligible for inclusion in the respective trial – information that could be useful when comparing results from an observational study to clinical trial results.