A few years ago, the idea that primary care physicians might offer clinical trials as a routine part of care seemed far-fetched. But today, a growing body of evidence supports the notion that integrating research into clinical care can improve efficiencies, bolster patient engagement and reduce cost.
“At first, this idea was a pipe dream,” said Jeff James, CEO of Wilmington Health. “Now, it has become a shared vision of many.”
Several years ago, PMG Research teamed up with Eli Lilly, Quintiles, Wilmington Health and The Advisory Board Company to test the notion that integrating research into traditional healthcare offerings would improve the care experience for patients.
The group designed a survey to measure satisfaction with research-related care among diabetic patients in an ongoing trial, and found that research participants reported reduced cost, improved engagement and better quality compared to traditional diabetes care.
This data supports a growing movement calling for a total redesign in healthcare operations. Proponents argue that trials should no longer be siloed, and that putting clinical research at the center of clinical care, rather than isolated from it, is likely to improve efficiencies in both systems.
If framed correctly, patients are likely to welcome this change, with a 2013 poll finding that 72% of patients would participate in a trial if recommended by their doctor. For patients, research “should be something on the menu of options,” Byrne said.
A lack of trust between stakeholders is the biggest roadblock to integrating research into care, experts agreed. “The lack of trust simply comes from the void that has traditionally existed between research and medicine,” said James.
Distrust is “a hard reality from which we need to operate,” said Byrne. Between the pharmaceutical industry and health providers, “one of the root causes is that compensation models do not align.”
“When a primary care provider sends one of their patients to a clinical trial, it’s a leap of faith,” James said. Typically, “they don’t get any feedback about what has happened in the trial,” which can be a frustrating experience for physicians.
Defining outcomes that are meaningful to patients, and applying that common language in research and care, will help “remove that lack of trust we see between the formalized science industry and healthcare,” said Christina Åkerman, M.D., Ph.D., MBA, president, International Consortium for Health Outcomes Measurement (ICHOM).
“From the patient perspective, they need to trust the process as well, and rest assured that this is a legitimate care option,” Wilmington Health’s James said.
Accelerating this movement will take concerted, top-down effort from both the research and medical industries. The first step, however, is to continue to “revamp the whole reimbursement model system” to conform with the principles of value-based care, said Greater Gift Initiative’s Byrne.
“On the pharmaceutical research and development side, [stakeholders should know that] this is not about getting data from patients, but rather a bidirectional partnership.” Byrne said that companies have a responsibility to “deliver data back to patients.”
“My advice to companies developing new treatments,” Åkerman added, “is to start gathering real-world data that matters to patients as soon as you start documenting your to-be product.” Åkerman said, “From a regulatory perspective, that’s something we lack today.”
Pharmaceutical and device companies also must start building clinical trial records that conform with national electronic medical record (EMR) standards, said James. Right now, trial management systems don’t “talk to” EMRs, and it is the research industry’s responsibility to bring their systems in-line with EMR standards.
On the hospital and care organization side, board members and CEOs should start “redesigning some of the financial, structural and educational components” of the system so that “robust clinical trial offering can become part of the ongoing continuum of care options for patients,” Byrne said.
Doctors should be able to refer patients to research just as easily as any other in-hospital referral, according to James.
The movement for integrated research “can certainly be a catalyst and for improving the efficiency of the system overall,” Byrne said. Specifically, experts pointed to the opportunity to improve research through more robust data collection and patient-oriented outcomes measures.
“By integrating research into clinical care, the amount of new data and historical data collected can redefine how the industry looks at outcomes,” Byrne said. The pharmaceutical industry also has an opportunity to reexamine portfolio development.
By monitoring long term outcomes within a typical health system, the industry will be able to identify “gaps in treatment” and “guide research and development to where we don’t have treatments today,” Åkerman said.
Experts also pointed to potential benefits for patients. James said, “We can already demonstrate that clinical research dramatically improves patient engagement.
“It also improves outcomes and there is even a butterfly effect, meaning comorbid conditions that aren’t even under study improve,” James said. Moreover, “we can correlate that to the overall cost of healthcare to the patient and to the system goes down.”
Finally, there is also a benefit to hospitals and health systems, because integrating research could help address an unmet need within the system’s patient population, and bring in new therapies to improve those outcomes.
Byrne said, although it will be difficult to navigate the trust challenges, the concept of incorporating research into care brings value to all stakeholders.
“We have been working on this idea for about three years,” said James. “The first time that we mentioned it, it was an oddity.” Now, the movement is building momentum.
This article was reprinted from Volume 21, Issue 14, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »