HISA’s Breakfast Series came to Brisbane in April and sponsor TriNetX Chief Medical Officer Manfred Stapff gave a valuable presentation on using real world data to drive clinical trials.
By Dr Josie Di Donato, HISA Advocacy and Leadership Director, who attended the breakfast.
There are many use-cases for electronic medical records (EMRs) and Dr Stapff showed glimpses of the disruptive innovation integrated EMRs can bring to clinical trials research.
Of all the ways that scientific research can be conducted, the traditional randomised controlled clinical trial (RCT) sits on the mantle as the gold standard for producing the highest level of evidence for new treatments and therapies. However, clinical trial sample data and its parameter-driven environment of: informed consent, inclusion and exclusion criteria and selection bias does not reflect patients in the ‘real world’ with the same conditions researched. From a rigorous scientific point of view (to which RCT are well regarded), study results can really only be applied to the actual study population and not the broader population.
The Fourier Trial, a very famous cardiovascular trial, demonstrates this dilemma. The criteria for recruiting the patient sample were so narrow, with only 10% of patients satisfying the criteria, that the benefits of the treatment would only be to 10% of patients with atherosclerotic vascular disease.
According to Dr Stapff, the inclusion and exclusion criteria for clinical trials can be determined arbitrarily. Because of this, the applicability of the results to the real world population with a particular medical conditions can be significantly affected. For instance, whether the cut-off points for age is 65 or 70 may be of no consequence to the study, but can have a significant impact on the study’s representativeness (and therefore relevance and efficacy) to the real world population with the condition/s under study. The risk is that treatments considered to be effective and safe may not be.
The use of real world data through electronic medical records allows clinical trials to be better planned and interpreted. It enables a data-driven discussion about study criteria, showing what treatments patients are on, what their laboratory results are, how old they are and so forth. EMR data can be used to test the impact of eligibility criteria and any enrolment hurdles.
Imagine clinical trials run as federated health research networks, using EMRs as the conduits. Breaking down the facility-specific silos would bring to the experimental context a reality check and a tool for better sampling of study populations. Another reason why interoperability, data standardisation, structured data and agreement on terminology makes good sense.
HISA collaborates with industry partners to bring the complimentary breakfast series to the digital health community.