As part of our series on clinical data collection and management, in this exclusive interview, Dennis Salotti, Vice President of Operations at The Avoca Group, explores the potential of data extraction from electronic health records (EHRs) for patient recruitment and the challenges that still need to be overcome. Explore other posts from the clinical data series here.
With new technologies, there are numerous innovative ways to collect clinical data. Which do you think are currently and will be the most effective?
DS: ‘Direct data extraction from EHRs represents the greatest opportunity to drive efficiency and positively influence quality in clinical research. Today, there are existing solutions that mine EHR data to locate patients for targeted recruitment and direct referral to investigators (physicians running clinical trials). As standards mature in this space – and the healthcare ecosystem increases adoption and standardization of electronic health records – the accessible patient populations will grow, and this opportunity will become more valuable. Standards to move EHR data into clinical research database systems are already emerging such as BRIDG from CDISC.’
What benefits do these technologies offer for both those running the trial and the patient?
DS: ‘Sponsors and CROs stand to recognize the obvious benefits of more rapid identification of eligible patients and potential reductions to recruitment timelines. With 80% of trials missing their recruitment timeline objectives, this stands to address one of the most persistent challenges in clinical research.
There is also, however, an opportunity to drive higher quality into trial protocols through proactive evaluation of the protocol entry criteria by examining the results of querying the proposed entry criteria against EHR data sets. In this capacity, EHR data sets empower smarter designs and influence clinical development plans—an opportunity of far greater consequence to moving to a more proactive, patient-centric approach to clinical trials.
For patients, coupled with concurrent efforts to empower patients with greater autonomy over their data, EHR mining offers a mechanism to bring greater access to clinical trials and in a way that may spare them from additional procedures should they choose to screen and enter an active clinical trial.’
What challenges still need to be overcome?
DS: ‘The greatest challenge associated with EHRs is the fragmentation of healthcare data across paper and electronic systems, as well as across electronic systems that are not inter-operable, do not conform to a common standard and are kept in isolation from one another due to an absence of data-sharing agreements between organizations and governments. These barriers threaten delivery of high quality data through the risks of incomplete data and inaccurate translation of EHR data into the clinical trial database.
These are not, however, insurmountable challenges; we have seen standards emerge and organizations build collaborative structures to share data. For transformative influence on the clinical trials industry this must occur at a much greater scale. Consortia - pre-competitive collaboratives that unite Sponsors, CROs and the healthcare industry with a common purpose of establishing proactive approaches to managing data across the continuum of clinical research and clinical care - are an effective vehicle to realizing this opportunity for technological innovation to drive greater efficiency and higher quality in clinical trials.'
Learn more about The Avoca Group’s consortium here.
Explore other posts from our clinical data series here.