The clinical research industry’s most significant innovations today are being developed to address a problem that has plagued our industry for decades: the chasm between clinical research and health care. Though it’s still far too wide, that gap is narrowing through the efforts of groundbreaking technology, innovative approaches to research, encouragement for regulatory guidance, and meaningful partnerships — all steps unheard of a decade ago.
So, when the foremost thinkers in this arena assembled in March at the Bridging Clinical Research & Clinical Health Care Collaborative, we knew we had to get their pulse.
Below, we outline their thoughts about incorporating the patient’s voice, learning health systems, integrating research and health care, and the emergence of patient data as a facilitator of transformation. We conclude with a list of the most important steps that must occur if we are to move forward with this important task ahead of us.
Learning Health Systems
We asked conference attendees to select the top two benefits for patients of learning health systems. Three came out on top, and all three relate to better informed care. Few respondents believe a learning health system would allow health care professionals to spend higher quality time with patients or would lower health care costs.
Top Two Benefits of Learning Health Systems for Patients
Creating a learning health system is complex and requires process changes in the way health care organizations interact with patients, health care professionals, and data. So, we wanted to know what these thought leaders considered to be the biggest challenges. Their responses fell into two major categories: behavioral changes and data.
From the behavioral change perspective, patient education topped the list: Patients need to know enough about research to consider it as a care option, and physicians, health care organizations, and advocacy groups can play an important role in providing this education. Traditional physician behavior was also named as a challenge that needs to be overcome, but it came in at fifth place.
From a data perspective, data standardization and integration came in at second and third place, respectively. And in somewhat of a surprise — where data and behavior change intersect — fourth place was leveraging data without losing patient-focus.
Two Biggest Industry Challenges in Strengthening the Connection Between Research and Health Care to Realize a Learning Health System
Incorporating the Patient’s Voice Into Research and Health Care
Patient-centric research and care has been a popular concept in recent years to both improve and accelerate research and enhance patient care. To learn more about how organizations are incorporating the patient’s voice, we asked attendees about their strategies. While they use a variety of techniques, almost half work with advocacy groups. However, interviews, focus groups, and online surveys remain important methods for gaining patient perspectives. Less than 20% of organizations do not incorporate activities to engage with patients.
Methods Used to Incorporate the Patient’s Voice in Health Care and Research
Incorporating the Patient’s Data Into Research and Health Care
Integrating real-world data and real-world evidence into research offers many benefits. For these thought leaders surveyed, these three came out on top: improving clinical study design, informing health care, and accelerating product evaluations by regulatory agencies.
Most Significant Benefit of Integrating RWD/RWE Into Regulated Research
Who Is Driving Innovation?
When it comes to innovation, these thought leaders are seeing a shift from the traditional ecosystem of pharmaceutical companies, CROs, and hospitals. Instead, they say technology companies, nonprofits, and advocacy groups tend to drive innovation.
Organization Types Bringing Forth the Most Ground-Breaking Approaches
Technology and Data Take Center Stage
Technology and data are at the forefront of many of the transformative approaches currently underway that seek to integrate research and health care. But this new reliance on technology, data, and automation comes with its own problems. We raised this concern with conference attendees: What keeps them up at night?
Their top response relates to the inherent complexity and potential failure points. In close second, attendees expressed concerns that researchers and health care professionals and organizations may forget about the end goal: patients and their health.
In an Increasingly Digital World, What Keeps You Up at Night?
When Will We See Evidence of Change?
Learning health systems can benefit both research and health care. But when will the industry see a broad emergence of learning health systems? Responses were mixed: 53% of respondents expect to see the transformation in five to 10 years. Another 40% say the transformation will be sooner — in two to five years.
When Do You Believe We will See Broad Emergence of Learning Health Systems That Transform the Patient Experience and Improve Health Outcome?
With data, technology, and automation taking a more prominent role in research and health care, there are significant opportunities for researchers and health care professionals to transform the way we develop medicines and medical devices and improve patient health outcomes. However, as the industry, health care organizations, regulators, and technology companies focus on the potential benefits, it is important to proceed carefully to address some important prerequisites and risks.
From these survey responses and other insights gleaned from the Bridging Collaborative, it is clear that there are some imperatives the industry must tackle. To safely and effectively move forward:
- Data standards need to be established and codified to ensure we can evaluate all data and information effectively, across research and health care.
- Patient data ownership and use need to be directed by patients, and privacy and protections specified by legislation.
- Software and systems need to robust and validated to ensure data accuracy and functionality. These systems need to be “fail safe” as the impact of the data will reach far beyond an individual patient and could influence the care and outcomes of thousands of patients. Only with good, reliable information will researchers and physicians be able to make informed decisions.
- We need to maximize the contributions of all stakeholders: patients, advocacy groups, the clinical research and the health care industries, and regulators.
- Finally, we cannot forget about the individual patient. Regardless of data, physicians and patients still need to have open and candid conversations about the patient’s health. We cannot forget that a patient is not an agglomeration of patient data, but an individual who needs personalized care.