The clinical research business is approaching an inflection point similar to the shifts seen over the past 25 to 30 years, only now the trends are toward consolidation in larger health systems and their affiliates that can take a more patient-centric approach, according to Ken Getz, director of sponsored research programs at the Tufts University Center for the Study of Drug Development.
“So many of the conditions that existed 25 years ago are analogous to where we are now,” Getz said last week at the Bridging Clinical Research and Clinical Health Care conference in National Harbor, Md.
Historically, academia and clinical practices viewed participation in research as a hobby, or as a way to get closer to the cutting edge of medicine. Today it’s seen as a mission-critical source of revenue, driven in large part by patient demand for new treatment options, he said.
Industry moved away from academia because it is overly bureaucratic, with high fixed costs, and lacking the speed and efficiency being developed in the community-based investigator and contract research settings.
Now, the trend is toward health systems that are making strategic investments in clinical research infrastructure, looking to expand their service areas and gain a competitive advantage amid intense revenue pressures and declining margins. In addition, many smaller and specialty practices are being absorbed and integrated into larger corporate structures.
When viewed alongside the constant need to recruit more patients from wider geographic areas, with catchment being automated through electronic medical records and other databases, it’s easy to see these factors pushing a convergence between research and care delivery within the clinic, he said.
“The infrastructure now, heavily supported by rich data and robust analytics, is the engine behind the patient-centric environment that puts the health care provider, as well as the larger health systems, at the core of this new shift and the opportunities that exist,” Getz said.
And with the increasing complexity of clinical trials and growing focus on rare diseases, it will become more difficult to find experienced physicians, as well as relevant patient populations, across a fragmented landscape. That will drive the need to better use data to pinpoint study resources, and leverage affiliate relationships with specialty providers.
In addition, there are currently about 35,000 unique investigators working on at least one clinical trial, according to the FDA, with most only conducting a single study, with high churn rates.
This fragmentation brings its own problems — with many of the solutions being siloed themselves. Fixes are usually tailored to specific, individual issues as companies try to close out studies as quickly as possible, and the advancements aren’t spread through the industry.
Meanwhile, the vast majority of clinical trials are led by smaller companies outside the top 50 pharmaceutical and biotech giants. And, because many may not have experience managing clinical trials on their own, more are engaging CROs for support. These companies have shown to be more willing to innovate and challenge the traditional practices implemented at the larger, more established pharma companies, Getz said.
“There’s some important news there,” he added. “This may become a valuable driver for us as we look to move more research into the larger health system and healthcare setting.”
Patients are also pushing for clinical care and clinical research to be seamlessly integrated.
“We continue to gather a lot of data that not only underscores the tremendous trust patients place in their healthcare provider, but their desire to first learn about a clinical trial as part of their routine care,” Getz said.
And contrary to popular belief, providers are generally comfortable talking about clinical research with their patients, he added. Many are familiar with it from professional society meetings, or through their own medical or nursing training. However, the challenges lie in referrals.
“A high percentage of physicians tell us that they do refer patients — but the number they refer, as a percentage of the total number they see in a given year, is remarkably low,” he said. Physicians often don’t know where to find the information to help them make a referral with confidence, and don’t have the time to fully process that information once they have it.
To bridge the gap, industry should take new approaches to informing physicians of their options, said Craig Lipset, head of clinical innovation at Pfizer.
“Over half of physicians are in a health system,” Lipset said. “And we still engage them as solo practitioners.”
Companies should look for existing principal investigators in already planned studies that are part of health systems, which may offer connections to thousands of researchers under a single medical group, he said. And leveraging their health IT infrastructure can assist in patient identification or even electronically sourcing data in parallel with the study.
“How many times do you see where patients exist with no way to reach them?” he asked, adding that health systems already have permission to reach out to those patients. “You don’t have to wait for a bridge to get built.”