Navigating a Digital-Era Shift to Patient-Mediated Research
The potential of personal health records to bridge the gap between research and care.
New digital technologies are transforming possibilities in clinical research and driving a surge in real-world data (RWD) availability. This presents a huge opportunity, as we combine an increase in data volume with advanced machine learning analytics to unearth previously unseen insights and valuable real-world evidence (RWE). However, the increase in RWD is also leading to challenges that the industry must address. These include ensuring the accuracy of data obtained from sources such as electronic health records (EHRs) and addressing concerns around security and privacy. In this landscape, patient-mediated research (PMR) can guide future developments and improve care and treatments, placing greater emphasis on the patient as a partner in their treatment and care.
New approaches, such as personal health records (PHRs), are providing solutions to these challenges. PHRs put the power back into the hands of patients, giving them full control over how their data is used, increasing patient engagement, and allowing any errors to be quickly identified and rectified. They also unleash new potential by enabling direct engagement with patients and faster set up of clinical research studies, as well as providing access to longitudinal data, supporting conduct of RWD studies in all regions.
However, to seize the opportunities on offer and meet the challenges of rising data volume head on, we need greater integration of PHRs to bridge the gap between research and care. By doing so, we have an opportunity to integrate all stakeholders across the health ecosystem and create an holistic approach to research, patient care, and therapeutic innovation.
RWE: Opportunities & challenges
RWD allows us to resolve knowledge gaps between clinical trial results and the real-world use of treatments and devices, especially among previously excluded populations. The FDA says advances in availability and analysis of RWD have increased the potential for robust RWE.1 In the UK, the National Institute for Health and Care Excellence (NICE) says RWD can improve understanding of the effects of interventions in routine settings.2
While it has become routine in areas such as pharmacovigilance to collect data from sources other than randomized clinical trials (RCTs), the use of RWE is less established in earlier stages of drug development.3 This is despite researchers identifying several advantages of RWE studies compared with RCTs. These include the potential for increased detection of rare adverse events, rapid data access, the ability to evaluate the natural history of disease and meet unmet needs, and conducting research not possible with RCTs.4
However, RWD is not without its challenges. These include generating the quality and quantity of the data and securing the inclusion of patients while respecting their right to privacy. Even though more data is being collected than ever, there is low public awareness of how data is used to improve healthcare services through research.5 There is also concern that developments can result in forced data sharing, or lack of real comprehension regarding data collection among patient populations.
EHRs are often touted as a potential solution to some of these challenges because they provide a detailed account of a patient’s history. However, at least half of EHRs may contain an error, often linked to medications.6 There are multiple potential reasons for this, including a lack of time, information not being updated when patients see multiple healthcare providers (HCPs), and changes in prescriptions going unrecorded.
There is also a lack of fully distributed EHRs that allow all participants—including family doctors, nurses, specialists, and patients themselves—to contribute. Technical challenges can lead to questions about who can access data and how to clearly differentiate between information provided by patients and HCPs.
Instead of relying on EHRs, we need to shift our focus to medical records that put people in control of their own data. PHRs can be accessed by the patient directly, increasing engagement and giving them the power to easily rectify errors. This, in turn, improves patient care and the quality of data.
Unlike EHRs, PHRs can collect data from multiple sources, including connected devices and other apps, while still giving patients complete control of their data. They can also help to tackle the privacy concerns associated with cloud-based solutions, because data is only stored on a mobile device and exchanged in a distributed peer-to-peer method.
Increased accuracy and privacy
PHRs bridge the gap between research and care to help usher in a new era of PMR.
The Ebbinghaus Forgetting Curve illustrates just how rapidly verbal communication is forgotten, especially when it includes data. Yet, every time a patient visits a doctor or trial site, they are asked multiple questions about their medical history and are given verbal medical diagnoses.
By allowing patients to capture and easily access their health data via a smartphone, we can empower them to give more complete and accurate information in their engagement with a broad range of health specialists and researchers. This can increase understanding of treatment efficacy and improve the reliability of results.
With privacy-by-design, PHRs empower patients to take complete control over how their data is used. Advanced eConsent and re-consent solutions can increase understanding of data use, test and reinforce comprehension, and boost the acceptance of data sharing.7
The same tools can be used to expand the patient recruitment process by allowing consent materials to be adapted into different formats that meet diverse learning styles and levels of health literacy.
In an environment where HCPs are time-poor, PHRs directly engage patients in research with sponsors. This can not only help to make research more efficient, but also allow patients to witness the impact of their contributions. When clinical trial patients feel more engaged, know their contribution is valued, and are in control of what is shared, they are less likely to drop out of clinical studies8 and more likely to manage the quality of their responses more accurately.
At a development level, PHRs can be used by pharmaceutical companies and medical device manufacturers to reach patients via electronic questionnaires. Again, this increases engagement because, rather than using a clinical trial app that is of limited benefit to them, the participant is instead using their own PHR.
While traditional RCTs offer limited data over a set period, PHRs provide a lifetime of data, which is invaluable for longitudinal studies. They can offer insights into, for example, the efficacy of a treatment for older people or those with comorbidities who might be excluded from traditional trial-selection criteria. Over multiple studies or longer time periods, an extended relationship can be achieved with patients and a wider range of data collected.
PHRs can also offer unique insights into rare diseases and enable more personalized medicine, based on personal characteristics. Additionally, because they do not rely on a live internet connection, they allow all regions, including developing areas, to be involved in research, enabling truly global RWD.
What needs to happen now?
PHRs, which allow users to continually collect, share, and control their health data, can bring about a future of more efficient research, targeted treatments, and therapy innovations. They provide “real” real-life data and have a vital role to play in preventative and precision medicine around the world.
To fully unlock the potential of PHRs, wider adoption is required. With global health interoperability now secured, greater integration with other services across the health ecosystem is possible.
We also need to make it far easier for patients to access their own data, so they are empowered to share it and contribute to global research, no matter where they reside. This requires governments to not just say patients have a right to their data, but to outline how this should be done.
PHRs are a critical factor in patient-mediated strategies. By empowering patients with their health data and giving them control over how it is used, it enables everyone to contribute to research, resulting in better outcomes for individuals and the wider health ecosystem.
Vincent Keunen is Founder and CEO, Andaman7
References
1. FDA, Real-World Evidence (February 5, 2023). https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
2. National Institute for Health and Care Excellence, NICE Real-World Evidence Framework (June 23, 2022). https://www.nice.org.uk/corporate/ecd9/chapter/introduction-to-real-world-evidence-in-nice-decision-making
3. Use of Real-World Evidence in Regulatory Decision-Making – EMA Publishes Review of Its Studies. European Medicines Agency. June 23, 2023. https://www.ema.europa.eu/en/news/use-real-world-evidence-regulatory-decision-making-ema-publishes-review-its-studies
4. Chodankar, D. Introduction to Real-World Evidence Studies. Perspect Clin Res. 2021. 12 (3), 171-174. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323556/
5. Quick Guide to Explaining How Patient Data is Used. Understanding Patient Data. November 2022. https://understandingpatientdata.org.uk/sites/default/files/2022-11/Resource%20quick%20guide%20v%203.0.pdf
6. Bell, S.K.; Delbanco, T.; Elmore, J.G.; et al. Frequency and Types of Patient-Reported Errors in Electronic Health Record Ambulatory Care Notes. JAMA Netw Open. 2020. 3 (6), e205867. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2766834
7. McDonald, L.; Malcolm, B.; Ramagopalan, S; Syrad, H. Real-World Data and the Patient Perspective: The PROmise of Social Media? BMC Med. 2019. 17 (11). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334434/
8. Poongothai, S.; Anjana, R.M.; Aarthy, R.; et al. Strategies for Participant Retention in Long-Term Clinical Trials: Participant–Centric Approaches. Perspect Clin Res. 2023. 14 (1), 3-9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10003583/
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