ACDM’s (Association for Clinical Data Management) eDigital data management expert group (DMEG) focuses on driving thought leadership discussions on how current innovative digital technologies are changing and enhancing the resources available to data managers.
In this interview, Lauren Ellis-Hill, Associate Director Business Development at Cytel and chair of the eDigital DMEG, talks about her latest publication on Electronic Health Record (EHR) Integration.
Tell us about your role at Cytel
I work in Business Development and predominantly focus on Cytel’s software solutions. My primary work lies in the clinical trial design space, particularly East®, Cytel’s flagship product. Recently, I have also been involved in the launch of our incredibly innovative, new software, Solara. It combines our proprietary algorithms with massive amounts of cloud computing to really open up and explore a much wider design space for clinical trials.
I am very passionate about supporting innovation, especially within the software space for life sciences. Ultimately for me, it is about enabling the advancement of better treatments and improving quality of life for people all over the world.
You chair the eDigital team of the Association of Clinical Data Management (ACDM). Tell us more about this expert group and your responsibilities.
I have been the chair of this group since May 2019, and it is an extremely rewarding experience. I work with industry thought leaders who are mostly data managers, and our mission is to be a forward-looking source of expertise and knowledge in digital advancements. We are driven by the needs of the industry and regulatory requirements and aim to advise our community of data managers. We also share our collective experiences with this group to ensure that we are at the forefront of knowledge and to support our wider community.
As a part of the ACDM eDigital Data Management Expert Group, you along with the other authors, recently published a reflection paper on the practicalities of integrating Electronic Health Records (EHR) into the trial data for secondary or exploratory endpoints. What are the key objectives of this publication?
This paper reflects our thoughts and discussions, most of which was pre-COVID. Our intent is to share the information we have discussed to date with a view to help our community decide whether EHR integration is suitable for their clinical trials and to be able to make informed decisions.
The paper collates our considerations on the practicalities of integrating EHR into the trial data for secondary or exploratory endpoints. Our discussions were around several things including, what systems are used, how to integrate with these systems and the challenges still faced. This paper is the first in a series of publications that is intended to explore and build knowledge in the EHR space.
How is EHR currently used in clinical trials and how can we anticipate use in the next few years?
I feel EHR data is currently underused, and I think that is partially due to the challenges in the quality of EHR data and because of the lack of standardization across healthcare. Many companies employ large teams of medical professionals who can provide a manual review of the EHR, which presumably incurs a large cost because of the person power involved.
However, with the rising interest in EHR data, there has been an upsurge in innovative software companies. The Fast Healthcare Interoperability Resources (FHIR) standards used by these companies are helping sites to be eSource ready. There is also an increasing support from the regulators for the use of EHR data. I anticipate over the next few years, there will be a growth in adoption for this type of data.
The publication mentions a variety of EHR records across geographies. What are some key insights a data manager would need to know to tackle this diversity?
High quality EHR data is available in certain countries. For example, the US is mentioned having generally good EHR data in order to meet payer requirements, however the method and variety of data collected still varies from site to site and sometimes even across different departments. In Europe, there are an increasing number of sites that are becoming eSource ready. However, some countries have specific challenges, for example, in Germany, EHR data tends to be in the form of a letter. The advice is to be very cognizant of which countries you are targeting for your clinical trial and to ensure that your knowledge is up to date on the way EHR is collected and documented within those countries.
It is also important to be site specific and not just country specific, when checking for eSource readiness. There are certain progressive hospitals who have already become eSource ready but there are others that still have not even considered it. It is important to note, this is still an emerging market and that we are very dependent on researching which countries are suitable and identifying the sites that are set up or are willing to work closely with you to become eSource ready.
Should biostatisticians in particular know anything about EHR? Can they help with EHR in any way?
The important thing to note about EHR data is that it can be a new source of data and although the extraction of data is usually done by data managers, biostatisticians can use this data to create prior distributions for synthetic control arms where there are ethical or practical reasons a control group cannot be used. Essentially, this specific dataset is not clean clinical trial data, it is real world data. Hence, there is cleaning involved and it may not be as easy to use as it would be normally.
How does EHR handle missing data? What other kinds of data challenges might there be and how should sponsors respond?
EHR data is not clinical trial data therefore it is likely that you will come across missing data, however even considering this, you can still extrapolate patterns and look for trends using machine learning or modeling. There may also be an option to source the missing data in another area and with consideration for how important the data really is. It would be a problem if, for example, the data was the endpoint and you may need rules to indicate what level of missing data is acceptable.
In the paper, we discuss another challenge involving data recording. The example we gave was of taking a blood pressure reading. The nurse may have taken three readings, therefore someone with medical knowledge has to decide which reading to take as the relevant data point. We need to place some rules around these decisions, and being very clear on these from the onset can help you maintain consistency.
It is also really important to work closely with the site investigator to make sure that you have permissions from all the relevant stakeholders. For example, if you need images from a patient, then you may need separate permissions from the radiology department.
Can you tell us briefly about the learnings from your discussion?
This publication aims to answer the questions that are top of mind for many data managers. It also includes practical considerations of whether EHR data should be included in clinical trials. Firstly, by ensuring you are not including EHR data for inclusion’s sake but have the right reasons for wanting to include that data and then how to proceed from there. In this first piece, we chose to focus on industry and country level challenges.
I think it is very exciting to explore the emerging market space, to look at the digital innovations and observe the increasing adoption of FHIR standards.
What do you think is the future viability of integration with EHR?
Our next content piece on integration of EHR data by ACDM’s eDigital team, will be focused on providing our perspective on whether the industry is ready. We will be interviewing companies focused in this area providing our more recent experience in this area. But certainly, there are great benefits of tapping into such a rich source of data that can provide a longitudinal perspective of the patient journey across a diverse range of patients. Considering the uptake in FHIR standards to eSource readiness, I really do believe that EHR is seeming like an increasingly viable option moving forward.
What are the factors that a sponsor should consider when selecting a technology partner for EHR integration?
I think the important thing to consider here is that you need to feel confident in the partner you have chosen to work with. You can build that by focusing your search on companies who have already implemented technology and have proven use cases to show its effectiveness. Look for people who are already working with big sponsors, and who have been evaluated by peers as well as bodies such as the EHR2EDC consortium, that includes AZ, Sanofi and Janssen. Lastly, demo the software and analyze if it fits well with your organization’s objectives and needs.
Click the button to read the paper.
With thanks to Tracey Lavery, Dan Hyde, Francis Kendall, Pantelis Vlachos, and ACDM’s eDigital team.
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.