Major trends in drug development will reshape the global investigative site landscape. Trends to look out for include patient centricity and big data to CROs assuming responsibility for site effectiveness and patient recruitment.
As the landscape evolves, sponsors and CROs will offer patients more convenient locations for clinical trial participation, motivated in large part by the desire to engage patients as partners in developing new medical treatments. The site landscape will continue to consolidate as CROs, which increasingly manage site operations for sponsor companies, buy investigative sites or establish strategic partnerships with high-performing sites in order to have closer involvement and more control over site conduct. Clinical research will move from small investigative sites toward larger hospitals, healthcare systems and site networks. Sponsors and CROs will continue to place clinical trials in settings that have the infrastructure to support electronic health and medical records, and large patient populations.
“There is going to be a huge transformation in the investigative site landscape. It’s going to be dramatic and it’s accelerating. Sites may not be aware that it’s happening,” said Mark Lacy, founder and CEO of Benchmark Research.
Strategies and partnerships implemented throughout the clinical research industry in recent years offer insight into the direction the site landscape is moving. Icon’s groundbreaking acquisition of PMG Research, for example, and strategic partnerships between other CROs and experienced investigative sites signal new CRO/site relationships and greater consolidation in the space. Similarly, a parent company of PPD—Jaguar Holdings—invested in Radiant Research, one of the country’s largest integrated site networks, last April. The two companies operate independently.
LabCorp’s acquisition of Covance and the joint venture between Quintiles and Quest Diagnostics offer global CROs access to thousands of remote laboratory locations where patients potentially could participate in a clinical study. Benchmark Research has begun a new model that combines clinical research sites with urgent and family care centers located in high-traffic retail areas. There are many examples of sponsors and CROs establishing partnerships with healthcare systems and site networks that have access to large amounts of electronic patient data.
CenterWatch looks at how some of the most important drug development trends in recent years are likely to change the global investigative site landscape and what they could mean for independent, community-based sites going forward.
As the concept of patient centricity has moved to the forefront of drug development, efforts are underway to offer patients more convenient locations for clinical research participation, including urgent care centers, pharmacies, laboratories and other places that are typically open on weekends or in the evening and are close to where patients live and work. A recent Center for Information and Study on Clinical Research Participation (CISCRP) survey found that the location of research sites was the factor that caused study volunteers the highest level of stress and was one of the top three considerations for patients when deciding whether to join a clinical trial. Many sponsors and CROs have formed internal teams to explore new ways to use existing healthcare infrastructure in order to gain access into patient communities and offer study participants greater convenience.
“We are engaging with a variety of different healthcare providers in that space to look at the opportunities and what the right types of studies are for those types of settings,” said Maria Fotiu, vice president of Global Clinical Development, head of the Site Intelligence and Activation (SIA) group at PPD. “If the goal is to continue to bring innovative medicines to market, to look at ways to reduce the administrative burden on the site and to improve the patient experience in clinical trials, looking at new models is very important.”
Some companies are considering a hybrid approach where patients would travel to the primary investigative site for the first and last study visits; follow-up appointments then could be handled at smaller, more conveniently located facilities in the community.
“We are seeing a move toward acceptance within the industry—from CROs and pharma companies—that logistics and ease-of-access for the patient are really important. I see an expansion of locations that offer clinical trials,” said Clare Grace, Ph.D., vice president of Site and Patient Access at INC Research. “It will be places like pharmacies, community care centers and social care centers that are under a healthcare umbrella.”
Quintiles and Quest Diagnostics, which last year formed a joint venture called Q2 Solutions, already have begun to leverage Quest’s 2,200 patient service centers (PSCs) in the U.S. to reduce the burden of clinical trial participation. Q2 has used its PSCs to collect specimens for clinical trials rather than send patients to the primary investigative site for those procedures. Some of these PSCs are full Quest clinical laboratories, but others are smaller facilities located in a physician’s office, hospital or another type of healthcare setting.
So far, Q2 has more than a dozen live studies that use either PSCs or mobile phlebotomists, who draw blood samples from patients in their homes, to collect specimens from clinical trial volunteers in their communities. Q2 also is looking to partner with home healthcare providers to collect study data. Most often these remote study visits include telephone appointments to assure patient care and to gather other needed trial data.
“This is a great example of optimizing the patient and investigator site experience,” said Q2 CEO Costa Panagos. “In some cases sponsors have been able to reduce the number of investigator sites and patient visits to investigator sites by utilizing PSCs for specimen collection. Ultimately, our aim is to help improve patient compliance and retention, potentially reduce the overall number of investigator sites, and reduce patient travel requirements and associated expenses.”
Currently, these service centers have been used only to collect specimens and samples for clinical trials, but the model offers the potential for transforming these locations into clinical trial sites for phase II and III studies in many therapeutic areas. Laboratories or patient service centers used in the context of a clinical research study would be subject to regulatory requirements similar to those already required at investigative sites.
“There is talk about the potential evolution of the industry. We have to keep our minds open and receptive to any possibility going forward. We haven’t yet eclipsed the point where we would actually put an investigator at the service centers but there is nothing stopping that from happening,” said Panagos.
In another example, Benchmark Research has launched an innovative model that combines clinical research sites with urgent and family care centers, which are typically walk-in facilities that have extended hours and are located in busy, accessible retail areas. The research centers and medical facilities in each city will operate as separate but integrated businesses. The centers will be located in the same building.
In March, new Benchmark Urgent & Family Care centers will open, and existing Benchmark Research investigative sites will be relocated in three cities—Austin, Texas; New Orleans, La.; and Sacramento, Calif. Three additional integrated facilities will open in San Francisco, Calif., and Fort Worth and San Angelo, Texas. Benchmark also has begun talks with the Urgent Care Integrated Network (UCIN) about expanding the model nationwide. At present, an estimated 7,000 full-service urgent care centers operate in the U.S.
The model helps raise awareness about clinical trial opportunities, since all patients seeking medical care are offered the chance to participate in research, and gives study volunteers convenient access to sites close to their home or work. Urgent and family care patients ineligible for current studies can agree to be contacted for future research opportunities.
“We have electronic health records like large, integrated healthcare systems. A patient may be coming in with a case of the flu, but we know he also has hypertension and what medication he is on,” said Benchmark’s Lacy. “The research exists within the confines of the practice instead of outside of the practice.”
Additionally, many see the potential for expanding the role of pharmacies in clinical research. In 2012, Walgreens and Novartis partnered on a novel approach that would allow clinical trial patients to visit their local Walgreens for routine checks of some vital signs, such as blood pressure, rather than visit the investigative site. Although Walgreens has since shifted its involvement in clinical trials to leveraging its customer database for patient recruitment, CROs and other service companies continue to explore the possibility of using pharmacies as alternative sites or as an additional way to educate patients about clinical trial opportunities.
“We have an initiative around how we make trials more efficient and there are a number of components to that initiative,” said Icon Chief Operating Officer Steve Cutler, Ph.D. “There are opportunities to access and monitor patients through pharmacies and even in their homes through smartphones and wearables. We are looking at a number of ways to make it easier for investigators and their patients to participate in clinical trials.”
Strategic healthcare partnerships
As studies become more complex and require more targeted patient subpopulations, larger pre-screened patient pools, and more sophisticated data and review analysis, sponsors and CROs increasingly look to move their clinical trials into settings that have large patient populations and the infrastructure to support electronic health and medical records. Most large CROs have established relationships with healthcare networks, hospitals or universities that allow them access to patient data that can inform protocol design and patient recruitment feasibility.
“The biggest advantage is the system’s ability to leverage its health data. It’s not only the patients’ indications and diagnoses, but the system’s prescribing information and ability to narrow down the patient population for a specific trial,” said Fotiu, who said PPD recently established a new relationship with a large hospital network that gives it access to almost 2 million patients.
At the same time, forming partnerships with existing site networks or creating new groups has become an important strategy for CROs. Most recently, PRA Health Sciences has partnered with the Alliance for Multispecialty Research, a network of 20 independent research centers. PPD also formalized relationships with eight investigator sites to create a pediatric investigator network. In addition, Quintiles just launched a network of 43 oncology sites, part of Quintiles Precision Enrollment (QPE), which combines the CRO’s technology platform with electronic medical records so that the CRO will only open sites when they have appropriate patients to meet protocol requirements. The network will expand to 80 sites by April.
“A network of sites sits across a geographic location allows us to bring the trial to the patient versus bring the patient to the trial site,” said Jeanne Hecht, senior vice president, global head of Site and Patient Networks at Quintiles.
Dedicated sites and site networks have recognized that they need to become more aggressive in this changing environment and offer approaches that offer sponsors and CROs greater access to electronic health records and make clinical trials more accessible for patients.
PMG Research, an integrated network of 48 physician practices and large multi-specialty healthcare institutions in the U.S., has established partnerships with four healthcare systems that include formal agreements to integrate clinical research into patient care. Through these novel agreements, 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, which will ultimately match the right patients to the right trials. With the completion of its merger with Icon, PMG anticipates forming additional partnerships with healthcare systems this year.
“Those large, integrated clinical research sites are very important to us. We are looking to improve the overall participation of patients,” said Icon’s Cutler. “These integrated health systems have a significant number of patients and access to those patients will be much greater through the network we are building. We would like to think that every patient who comes through the door would be a candidate and would consider going into a trial.”
Other dedicated research sites also are partnering with hospitals and large healthcare systems. The Baptist Health Center for Research (BHCCR), a Little Rock, Ark.,-based dedicated research site, has formed a partnership to essentially operate as the clinical research arm of Baptist Health, the largest medical system in Arkansas. In another example, the U.K.-based Synexus formed a partnership with the Northumbria Healthcare NHS Foundation Trust to jointly open a dedicated research center at a hospital in Hexham, England. The agreement gives Synexus, one of the largest international investigative site networks, access to specialized patients and the ability to conduct complex medical procedures. Synexus plans to open additional research centers within hospitals in the future.
“The design of trials has become more complex and sponsors want to get a lot of data from these trials. Sponsors want more specialized sites, such as an academic center or big hospitals,” said Synexus CEO Christophe Berthoux. “When we opened a fully dedicated research center in the middle of a hospital, we combined the best of both worlds. The hospital brings patients and specialized doctors who are respected in their fields and we bring pharmaceutical company-sponsored studies and our operational expertise.”
During the past five years, as sponsors increasingly expect CROs to manage site effectiveness and patient recruitment performance, CROs recognize that they need to exert more control over the investigative site pathway and form closer relationships with sites that can provide greater predictability and efficiency in site operations.
Leading CROs have developed preferred partnerships or strategic alliances with top-performing sites that allow them to invest time and resources into training programs, give investigators insight into industry pipelines so they are ready for upcoming studies and offer greater support for patient recruitment efforts. Many of these partnerships establish processes that can expedite study startup, reduce time for contract and budget negotiations and streamline the feasibility process.
Quintiles, which established one of the earliest site alliance programs, has dedicated partnerships with more than 1,200 global sites. The managed site network, which includes both large hospitals and small clinics, allows the CRO to support its partners and gain insight into their patient recruitment and clinical trial conduct capabilities. Other CROs have developed similar programs to better align themselves with sites, improve communication with investigators and address site needs. INC Research is in the process of launching a Catalyst Site program to build partnerships with sites and a framework for implementing best practices developed by organizations such as the Society for Clinical Research Sites (SCRS), TransCelerate BioPharma and the Association for Clinical Research Organizations (ACRO).
“We will be looking at efficiencies, new methodologies and new processes in conjunction with science to ensure that what we do internally is beneficial and not creating a burden of an administrative nature on the site,” said INC’s Grace. “The main goal is to improve predictability. We have found that the single most important thing that pharmaceutical companies want to see is predictability in delivery. They want to see us hit the timelines we set so they can get drugs to the patients when they expect they will.”
Icon’s acquisition of PMG Research is a fundamental part of its strategy to improve patient recruitment, site management and the quality of study data going forward. Icon plans to expand its sites in North America over time and ultimately sees a large proportion of the patients it recruits into clinical trials coming through this network.
“Having more involvement with sites and more control over what our sites are doing is very purposeful. Our planning around trial resourcing and timelines will be better because we will have better feasibility information and more opportunity for sites to provide input to protocols. It will allow us to plan better, budget better and be more efficient. As we go forward, the speed of recruitment also will improve because as we build our site network, every patient that comes into those sites will be a potential candidate for a clinical trial,” said Icon’s Cutler.
“This strategy will also improve the quality of our trial data,” Cutler said. “We will have sites that are really focused on and dedicated to recruiting and treating patients in our trials. While the investigators remain independent, we will have support staff within those sites who are really focused on the trial procedures and patient follow-up ensuring the quality and timeliness of the data collected is first class. We expect fewer protocol violators and minimal data queries ultimately leading to less time required from CRAs, which will allow us to reduce the cost of trials while improving speed and quality.”
Industry analysts expect other CROs will buy investigative sites or site networks to conduct late-phase trials going forward. Many large CROs already own early phase development facilities.
“It’s going to be the evolution of the industry,” said Synexus’ Berthoux. “It’s a sign that the industry is maturing. The industry will consolidate whether it’s a site business buying another site business or that CROs will move into buying sites. Different CROs will have different strategies. I don’t think there is a one-size-fits-all strategic move.”
Small, independent sites typically lack the resources and scale to drive greater efficiency in their operations and will find it challenging to address the major trends that are changing the investigative site landscape.
“We are seeing a lot of change. It will be very challenging for the smaller site to navigate that change,” said INC’s Grace. “But at the end of the day, there is an insufficient number of clinical research sites to sustain the demand that we have for clinical development and every site is needed. I don’t see that changing dramatically in the next 10 years.”
As the landscape continues to evolve, however, industry experts believe there will continue to be a role for the best-performing community-based sites, particularly those that focus on niche areas or specialty populations. As trials become more complex, some smaller sites can use telemedicine technologies to perform specialized testing on clinical trial participants without sending them to specialty locations. Physician-owned investigative sites also will continue to be an important source for vaccine studies or trials in areas such as diabetes that require large numbers of patients from community settings.
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 of Science degree from the Columbia University Graduate School of Journalism. Email email@example.com.
This article was reprinted from Volume 23, Issue 02, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>