Anticipating the convergence of health­care and clinical research to form learning health systems, a handful of organizations—some originating within the dedicated site network community, others within academia and the Veterans Affairs sys­tem—are partnering with community hospi­tals and large healthcare systems to transform the investigative site landscape.

The partnerships have been formed as spon­sors and CROs increasingly look to move their clinical trials into settings that have the in­frastructure to support electronic health and medical records as studies become more com­plex, requiring more targeted patient subpopu­lations, larger pre-screened patient pools and more sophisticated data review and analysis.

“There is pressure on sites to find a smaller needle in a the haystack. In order to find that, you need to sift through a larger patient base,” said Richard Pellegrino, M.D., Ph.D., president and CEO of Baptist Health Center for Research (BHCCR), whose dedicated site has formed an integrated clinical research partnership with the Arkansas-based Baptist Health medical system.

For PMG Research, a first-mover to estab­lish an integrated network of clinical research facilities, early findings show integrating clini­cal research within large healthcare systems can enhance volunteer retention rates, reduce screen failures, encourage greater physician engagement in research and improve patient satisfaction rates.

These new structures signal a major change for investigative sites. In the short term, op­portunistic players will establish partnerships to access assets and capabilities of larger health systems. Longer term, integrated research and healthcare networks may drive consolidation and marginalize small, for-profit sites.

CenterWatch profiles early adopters of inte­grated research and healthcare networks from a variety of settings and characterizes the po­tential for this new model going forward.

A site network-driven approach

PMG Research, one of the few integrated site networks that has the infrastructure, leader­ship and capital to implement the model suc­cessfully so far, has formed four partnerships with healthcare systems that include formal agreements to integrate clinical research into patient care. Through these partnerships, all patients are offered clinical trials as a care op­tion and PMG has access to electronic medical records that can be used for pre-feasibility as­sessments and ultimately matching patients to clinical trials. The partner institutions support the interest and involvement of their physicians in clinical research as part of their practice and actively educate both physicians and patients about the clinical research process.

“We are making a strategic, collaborative decision that we believe in clinical research and the value of clinical research,” said PMG Research CEO Jennifer Byrne. “We believe in the value of co-branding research within the practice. It’s not just on a study-by-study basis.”

Clinical research is conducted within the partner institutions, which are Summit Medi­cal Group in Knoxville, Tenn.; Wilmington Health in Wilmington, N.C.; Boice-Willis Clinic in Rocky Mount, N.C., and most re­cently Christie Clinic in Champaign-Urbana, Ill. PMG provides the healthcare systems clinical research infrastructure, including coordinators and regulatory staff, along with the contractual budget and startup functions, which allows standardization throughout the institutions.

PMG Research originally decided to forge new relationships with healthcare systems af­ter seeing a shift during the past decade from the majority of investigators owning their own practice to physicians increasingly being hired as full-time employees for healthcare systems. Byrne said industry estimates project that by 2020, 80% of all U.S. physicians will be em­ployed by healthcare systems.

“Our legacy model is working with inde­pendent physicians—small practices within the community,” Byrne said. “We still greatly value those relationships and we still have rela­tionships with a number of very highly quali­fied independent physicians. But when you look ahead to where the healthcare system is moving, we saw there was a need to align with larger, value-based healthcare providers.”

Byrne said partnering with healthcare systems can create “shared value” to better achieve the goals of all stakeholders. For in­stitutions, viewing clinical research as a care option can decrease overall costs, increase care and improve the overall patient experi­ence. Early data from Wilmington Health, which formalized its partnership with PMG in 2013, found that 95.5% of patients felt they were more engaged in their overall health as a result of participating in a clinical trial, a result that has become increasingly impor­tant as Medicare reimbursement rates now are based on patient satisfaction surveys.

The model also promotes more engaged investigators, since their institutions support clinical research as part of the care cycle for their patients, and increases clinical trial op­portunities for patients in the facilities where they receive their healthcare. Importantly, the partnerships also give sites the ability to contribute a larger percentage of study volun­teers in a more predictable way and ultimately add higher value for sponsor companies and CROs.

“It’s about how you can use clinical research as a vehicle to make their core business better,” Byrne said. “We are trying to be very mindful of creating this better-value opportunity for everyone in the ecosystem.”

Driving a network from within

BHCCR, a Little Rock, Ark.-based dedicated research site formed in 2012, has established an integrated clinical research system within Bap­tist Health, the largest medical system in Ar­kansas. BHCCR essentially operates as the clin­ical research arm of the Baptist Health system, which is comprised of seven hospitals and more than 80 clinics. Baptist Health did not have a clinical trial office before the partnership was formed, although some clinical research previ­ously had been conducted at the institution.

BHCCR’s Pellegrino is a prominent physi­cian and founder of a dedicated site—Central Arkansas Research—in Hot Springs, Ark., where he conducted research as a Principal Investigator for more than two decades. Pel­legrino initially approached Baptist Health leaders about the idea of creating an integrated clinical research system; senior management understood the value of the proposition and fully supported its development.

“This system doesn’t work unless you have the cooperation of the large medical system,” Pellegrino said. “But if you do, there are many benefits over an individually owned clinical re­search site.”

Pellegrino said an integrated research system gives investigators access to greater resources than a standalone site could provide, including patient databases that are orders of magnitude greater than what could be constructed by an independent site, along with the right to use diagnostic equipment and other clinical re­sources they wouldn’t have otherwise. Health systems also generally have relationships with doctors in every specialty and the close prox­imity to hospital facilities creates safer phase I units. Access to these resources can help shorten development time and improve the ef­ficiency of clinical trial sites.

Integrated clinical research systems also are well-positioned to help determine the feasibil­ity of individual protocols. With access to elec­tronic medical records, investigators can use large sample sizes in real-world situations to de­termine whether patients exist to meet the pro­tocol’s inclusion/exclusion criteria. Pellegrino said this feasibility assessment could reduce the number of costly and time-consuming proto­col amendments and result in better protocols, reducing the failure rate and accelerating the drug development process.

Clinical investigators working within large integrated medical systems also can help evalu­ate whether or not there is a market for the drug being developed. In the new healthcare deliv­ery system, where payers want to assess the cost benefits of alternative therapies, if physicians and payers won’t eventually adopt a drug it probably won’t be worth developing. Integrated clinical research systems can draw on expertise representing a variety of specialties—includ­ing physicians, pharmacy managers, insurance company personnel, billing staff and adminis­trators—to help determine the suitability of a sponsor company’s drug development plan.

“Determining the feasibility of drug devel­opment plans is something that the industry doesn’t always do well,” Pellegrino said. “If you have clinical investigators working with large integrated medical systems, you can put together groups that can comment on whether this drug actually does fill a hole in the thera­peutic regiment or not.”

A mid-Atlantic AMC-driven network

Johns Hopkins Medicine has helped drive the movement toward integrating clinical research with health systems by creating an unprecedented collaboration that links its Academic Medical Center (AMC) with a di­verse network of for-profit, community-based healthcare delivery systems.

The affiliation, called the Johns Hopkins Clinical Research Network (JHCRN), is comprised of the six hospitals within Johns Hopkins Medicine and five systems based in Maryland, Virginia and Pennsylvania; col­lectively the network provides access to more than eight million patients across the mid-Atlantic states.

While the member sites work indepen­dently to enroll subjects and conduct studies, they collaborate on the administrative aspects of research. Johns Hopkins University acts as the single contracting agent for the network and all members use the same Institutional Review Board (IRB). Clinical research meth­odologies, data management, research report­ing documentation, patient consent forms and safety criteria have been standardized and the network provides consistent training for those involved in conducting studies. In addition, network researchers use a centralized data sys­tem to coordinate information from diverse information technology and electronic medi­cal records sources, which can be used to better coordinate their own clinical research activities or joint clinical trials with other JHCRN insti­tutions.

The unique alliance between the promi­nent AMC and community-based healthcare systems was founded in 2009 to offer both government and industry sponsors access to larger, more diverse patient populations for their clinical trials and comparative effective­ness research studies in a variety of disease areas.

“We realized that just doing studies in aca­demic medical centers or just doing studies in the community was creating a bias about who would be recruited into a study,” said Adrian Sandra Dobs, M.D., director of JHCRN and a professor of medicine. “One of the important facts about any research study is that the data be generalizable. To do that, you need a very broad demographic. We wanted to ensure that we were recruiting subjects that were ethnical­ly, economically and socially different so that the data would be more valid and more gener­alizable. To do that, we required multiple sites. And to do that efficiently it’s important to have a collaboration across all of the administrative aspects of the research study.”

Through the JHCRN, a program of the Johns Hopkins Institute for Clinical and Trans­lational Research, Johns Hopkins strengthens the research infrastructure of community hospital affiliates and, in the process, allows a growing number of patients the opportunity to participate in clinical studies conducted in their own communities. The collaboration gives physicians access to academic expertise and resources at Johns Hopkins and the abil­ity to conduct research projects relevant to their communities. Dobs said the network also has been a “powerful tool” for getting new study grants from both industry and the government.

“We’ve gotten grants that we didn’t think we would get. But we were able to show a broad partnership and the wide demographic of patients. All of this has been positive,” she said.

An emerging network within VA hospitals

Efforts are underway to expand clinical trial opportunities at Veterans Affairs (VA) hospitals in New England through forming new partnerships that will advance industry-funded research. VA facilities historically have depended on federal funds to support research programs.

The VA New England Healthcare System re­cently began an initiative called the Clinical Tri­als Network (CTN), which unifies the region’s eight Department of Veterans Affairs medical centers into specific consortiums of study, such as cardiology, in order to significantly expand the number of clinical trials conducted in its hospitals. The CTN, which provides logisti­cal, administrative and operational support for researchers, was formed to give New Eng­land veterans broader access to cutting-edge research that targets diseases relevant to the population. In addition, an important goal is to implement key findings from these investiga­tions into clinical practice in order to improve healthcare for veterans.

At the same time, the Edith Nourse Rogers Memorial (ENRM) Veterans Hospital in Bed­ford, Mass., has established a new nonprofit or­ganization called the Bedford Research Corpo­ration, to more effectively manage private sector and non-VA federal funding for research pro­grams. Bedford Research will provide lead gen­eration services for the Principal Investigators.

Leadership has supported clinical research at the Bedford VA medical center by creating a mechanism that allots physician investigators time to work on projects, giving Bedford Re­search space and other resources and allowing investigators access to the VA’s electronic medi­cal records, which are part of the nation’s larg­est integrated healthcare network.

“We are actively looking for partners—new and old—to re-ignite the clinical trials going on at the Bedford ENRM VA hospital,” said Ste­ven Shirk, Ph.D., clinical trials coordinator at Bedford Research. “We are interested in clini­cal trials to get the newest medicine and the newest technology made available to veterans. We have a very robust patient population (with direct access to 20,000 patients) and we want to give them the best care available.”

Momentum and consolidation

BHCCR’s Pellegrino believes there will be strong industry pressures to move toward inte­grating clinical research with large healthcare systems going forward. Widespread adoption of this model could help shorten development timelines by improving the design and imple­mentation of individual protocols, particularly as drug sponsors look at increasingly specific patient populations, and better feasibility as­sessments of drug development plans could re­sult in more and better drugs to treat diseases. Yet he believes the formation of full-scale inte­grated clinical research systems will be difficult and time intensive.

“Once these systems are created, they are much more powerful than individual research sites in what they can do,” Pellegrino said. “But they can’t be created rapidly. It’s a difficult job to integrate clinical research into the hospital system. It takes trust between the researcher and hospital administration. And anytime you are working with large corporations, there are many parties that need to be dealt with. It’s a very, very different job than running your own clinical research site.”

Benchmark Research CEO Mark Lacy said one of the challenges in establishing a partner­ship with a large health system is that while there may be strong interest from administra­tors, internal research found that the ratio of physicians willing to participate can be as low as 2%.

“Given the low initial interest, you must be able to educate the physicians on the value of doing the research,” Lacy said. “Without them, you lose the value of the partnership, which is in having access to novel patients and bridging the divide between research and the clinical practice of medicine.”

Many ethical and regulatory issues also must be addressed when conducting research in a healthcare delivery setting. Privacy concerns about using electronic health records (EHR) to identify patients for clinical trial opportunities and who has access to that information also can be complex when establishing integrated clinical research systems and agreements will be different depending on the relationship be­tween a site and healthcare system.

Given the significant benefits of the inte­grated clinical research model, many believe wide spread adoption is inevitable, although it will take many years, and partnering with large health systems will become the next play for sites that are most strategic.

PMG Research’s Byrne believes as the site landscape continues to consolidate, similar to the movement seen in the CRO space during the past 30 years, there will be different types of models that can be adopted by forward-thinking site organizations to build the scale and infrastructure needed for success. While some sites will follow PMG’s lead in partnering with large healthcare systems, Byrne said there also are opportunities for sites to consolidate or align themselves informally with other like-minded independent organizations. Earlier this year, for example, PMG Research, Bench­mark Research and Miami Research Associ­ates joined forces to form an informal vaccine site network called VaxCorps.

CROs that already have formed partner­ships with large hospitals and health systems as part of initiatives to address patient recruitment challenges and get more physicians involved in clinical trials also will be well-positioned to play a larger role as more clinical research migrates to healthcare systems going forward.

Industry experts agree that the biggest risks are for the small, independent sites that have limited patient databases, infrastructure and financial resources. Although the investiga­tive site landscape will occur slowly, a grow­ing number of industry insiders anticipate that conducting research at small, dedicated, com­munity-based for-profit sites will ultimately become a dying model.

“On the [sponsor and CRO] end, they will probably initially play it safe and use a combi­nation of small sites and integrated sites in their studies,” Pellegrino said. “But ultimately, as they gain more confidence in larger integrated sites, they will move business over to the larger sites and away from the smaller sites. But I don’t think it’s going to happen overnight.”

 

Karyn Korieth has been covering the clini­cal trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master’s of Science degree from the Columbia University Graduate School of Journalism. Email karyn.korieth@centerwatch.com.

This article was reprinted from Volume 22, Issue 07, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>