Connecting the Dots: From Patients and Patient Data to New Approaches to Research and Care

In early March, Antidote's Head of Partnerships Lindsey Wahlstrom-Edwards and I attended the 2019 Bridging Clinical Research & Clinical Health Care Collaborative to share findings from our joint research on The Patient Perspective on Clinical Trials.

Bridging covered a broad range of topics relating to how clinical research and health care could be better integrated to improve both the patient experience and health outcomes. The conference started in the right place — from the perspective of the patient. Bridging focused particularly on how patient data can improve the clinical research process and health care.

Our survey complemented that topic. It focused on how a patient's knowledge, education, and condition influences them to participate in clinical trials, their personal health care decisions, and what would make them feel like a partner in clinical research.

However, the patient's role in improving health care extends well beyond participation in a clinical study. Increasingly, patients have a bigger role to play in the design of the research. For example, the conference touched on several key developments:

  • More patient-friendly studies: The use of artificial intelligence to gather data about patient preferences for medicines, medical devices, clinical outcomes, and education needs, when combined with behavioral insights, can inform product and research protocol design.
  • More efficient clinical research processes: Patient health information, in an electronic format such as an electronic medical record (EHR), can make research more efficient by assisting with recruitment, selecting enrollment criteria, assessing trial feasibility, and selecting sites. In addition, more efficient research can accelerate and reduce the cost of getting new treatments to patients.
  • Better regulatory oversight: Patients' influence can be even more far reaching with the use of de-identified patient data for regulatory purposes such as continued risk assessments and drug safety and quality oversight.
  • Improving health care: De-identified patient data can also be used to improve clinical care. By analyzing patient data across a hospital or practice, physicians can learn from clinical research and health care scenarios by evaluating the data and identifying what treatments, procedures, and support are most effective and what can produce the best outcomes.

And yet, despite the important role patients and their health data can play in improving care and helping to find new treatment options, there are two key challenges that remain for researchers.

First, by and large, EHRs from different vendors do not "speak" to each other. While we have made great strides in digitizing health information, these differences inhibit the ability to link and analyze information across different platforms. In addition, the EHRs' data structures are also different from the formats of data collected during research. These data format inconsistencies have created a barrier to assessing health data across patients, populations, and regions, restricting our ability to gain broader insights into best practices of care and to maximize the data collected during clinical research.

Second, while there is a role for data to play, we still need a human touch. And that isn't always something big data and technology companies can provide. Our research indicated that patients prefer to learn about clinical trials from physicians and other medical professionals. However, that means that engaging patients in research then relies on busy health care professionals remembering to discuss clinical research as an option with patients. Other than these physicians, only hospital systems have the right to contact patients, and they are disincentivized to refer patients to a trial at another institution. EHR companies and other vendors using EHR data cannot typically reach out directly to ask patients if they might be interested in partaking in a clinical study or learning more about research.

At the same time, these challenges can create opportunities for the industry and regulators to develop new data standards and rethink how patient health data is both used and protected from misuse.

Several speakers at the Bridging Collaborative proposed that we may have "fallen in love" with the existing problems of clinical research, and that the industry is plugging gaps, rather than looking for novel solutions to the big problem. Former FDA commissioner Scott Gottlieb supports this thinking and has faulted pharmaceutical companies and CROs with failing to take advantage of some of the new research technologies and strategies used to accelerate the clinical advancement of new medicines.1

While our research touched on the patients' perspective of clinical trials, the combined clinical research and health care ecosystem relies on both people and data. And when we see the importance of patient perspectives and patient data at the core of the ecosystem, it becomes apparent that we need to elevate the patient's position as an empowered stakeholder.

Getting a regulated industry to change may seem monumental. And the combination of our research and conference topics made me start thinking about the numerous questions that remain to be answered.

  • Is it time to start thinking about redesigning research from a blank slate — starting with patients at the center?
  • Should de-identified clinical and health care data be made available to all researchers and health care providers to apply knowledge for the benefit of all patients?
  • With the ability to acquire and analyze vast amounts of data and apply behavioral science, do we need to think beyond drugs and traditional health care and broaden the application of these techniques to maintain and restore health rather than only treat disease?

At the minimum, prerequisites are data standards and format harmonization, and the FDA has a program working on this complex initiative. Having formalized data standards would facilitate access to, and analysis of, anonymous health and clinical data by all stakeholders. This would allow all to share equal footing and, furthermore, would give them the ability to maximize the information to make better health decisions and diagnoses.

Additionally, while hospitals may have access to patient data through widespread EHR adoption, there's a problem: There's no clear definition of who owns EHR data. Even patients may need to file requests with several providers to get access to the information to which they are legally entitled. If we want to put patients at the center of the health care ecosystem, they need to own their data, and if they would like, have the opportunity to donate their data for use in research with a simple consent.

Even the European Union's General Data Protection Regulation (GDPR) — which is heavily protective of patient data — has provisions allowing researchers to retain patient data if it is in the social good or for archiving purposes that are in the public interest (such as scientific/historical research or statistical analysis). In the United States, regulators have the opportunity to correct the absence of adequate privacy controls so that patient data could no longer be available to be used to deny insurance coverage to people with preexisting conditions, used by health or life insurance companies to raise premiums because of relative risk, or tapped by organizations to profile patients for marketing purposes. Certainly data ownership was not taken into consideration with the implementation of EHR systems that were intended to make record keeping and data sharing within the care team more efficient. If health care and research are to be patient-centric, then we need to empower patients with ownership of their health data and provide tools that allow them access.

I'm confident that greater minds than mine are working on conceptualizing new approaches to research and health care. But patient-centric models and technology advances have presented us with an opportunity for transformation and the necessity for appropriate legislation to define data ownership and protections for patients. 

Once patients have their rightful place in the integrated research and health care ecosystem, my hope is that more transparent data and communication models will emerge that allow all stakeholders to make the most informed health decisions, be it by physicians, researchers, family members, or ourselves.