Improving Patient Outcomes through Clinical Research as a Care Option

Oct 16, 2020 | Clinical Research as a Care Option, News, TSN News

Improving Patient Outcomes through Clinical Research as a Care Option

By Joseph Constance 

Patient engagement is increasingly becoming a vital component of healthcare. There are indications that as patients play a greater role in their own treatment plan, their outcomes will improve, and the costs of their treatment will decrease. 

Then it should be no surprise that integrating clinical research into patient care – known as clinical research as a care option () – improves the value of that care. Giving patients the option of participating in clinical research by participating in clinical trials not only benefits patients, physicians, and the research community, it also promotes more patient-centric studies and increases the diversity of patients that have access to clinical trials.

Unfortunately, most physicians are disconnected from clinical trials. So, many physicians are not aware of the availability of clinical trials, and are not able to offer their patients a clinical trial option that could help their health outcomes. But it is time to close the gap between research and care, especially given the challenges of COVID-19. 

Myriad of Benefits 

Participating in clinical research offers many . Participants have access to advanced treatments in a setting where safety is of paramount concern. Participating in clinical studies generate a higher standard of care as patients are closely monitored by expert teams. 

CRAACO also offers benefits for study sponsors. Increased participation in clinical trials will reduce the costs and delays associated with recruitment, retention and adherence, essentially 

increasing the rate of new drug approvals. 

Integrating medical care with clinical research stands to facilitate increasingly complex trial

protocols, enabling pragmatic trial designs that can take full advantage of real-world evidence,  such as registry databases and electronic health records (EHRs). The trial

in Sweden, was a randomized, registry-based trial that measured the comparative effectiveness of routine thrombus aspiration in cardiac patients undergoing primary percutaneous coronary intervention. By utilizing pre-existing registry databases, the study was able to greatly simplify enrollment and achieved high follow-up rates. The final cost of the trial was about $2 million, 1% of what such a conventional randomized trial would cost. 

In addition, as healthcare systems transition to a model of value-based care, it is important

for providers to ensure that they are delivering the highest standard of evidence-based care, and participation in clinical trials is a step toward that objective. 

A Positive Perception 

The public has a highly positive perception of clinical trials. have revealed high levels of patient satisfaction and engagement with clinical research. Today, less than 1% of the US population participates in clinical trials, yet say they would participate if it were recommended to do so by their doctor. 

Routine Health Behavior 

In a national public opinion , a majority of those surveyed agreed that a discussion of a clinical trial should be part of standard care, and a majority would participate if asked by someone they trust, like their physician. Unfortunately, nearly 75% of respondents to the survey said doctors do not talk often about medical research. And, 44% agree that clinical trials should be routine health behavior. 

There are concerns, of course, about insurance coverage. Patients looking to participate in clinical trials will need to contact their to determine coverage, but often the trial’s sponsor will cover most of the costs. 

Technology and Data 

When a group of industry experts gathered at the , the consensus was that connecting healthcare and research can be a daunting challenge. But that should not be an excuse for not doing so. There’s generally an upside — the approach would improve engagement through a more patient-centric focus. And, technology could help. Artificial intelligence (AI) could be harnessed to search EHRs to collect and gather data to match those patients that could benefit the most from the research. Moreover, the data must be interoperable and easier to share with health organizations to realize its full value. 

But Little Integration 

Still, CRAACO has not been overly integrated into daily healthcare for . These include: a general lack of awareness of clinical trials; a lack of knowledge of the currently available clinical trials; a perception that clinical trials are burdensome and do not take into account the patient’s best interest; the belief that trials do not cater to participants’ individual needs; and ethical concerns within the industry about confusing research with patient care. This lack of integration into the entire healthcare ecosystem has limited patient awareness of clinical trials. 

Hesitancy about taking a chance with their health, concerns about the risks of clinical research, and the desire to avoid being treated as a guinea pig ranked as key reasons why patients do not participate in research. To overcome concerns over trust, the patient population could be made more comfortable by partaking in the study design process, such as by receiving information about a trial’s objectives and having an opportunity to provide insight on the outcomes of most importance to them. 

Less Than 3% 

“Unfortunately, less than 3% of physicians offer clinical research to their patients. Most physicians are not participating in this care option. They just don’t know about trials,” says Deena Bernstein, senior vice president for Network and Partnerships at ®, Buffalo, NY, an integrated research organization (IRO) that provides clinical trial opportunities to healthcare providers by offering a turnkey partnership solution in connecting physicians with sponsors of clinical trials. 

Circuit Clinical embeds its personnel into a physician’s office, providing all of the staffing and the requirements needed to connect patients with appropriate clinical trials. “This simplifies the recruitment process for the physician,” explains Bernstein. “We help to recruit patients right from their practice, so physicians aren’t involved in the demanding aspect of recruiting,” she notes. 

“It’s extremely helpful to be embedded and offer clinical research opportunities within a physician’s practice where patients feel most comfortable and trust their doctors. It gives comfort to patients to hear about a clinical trial directly from their doctor. Otherwise they’d likely never hear about a trial,” she adds. “It’s all about building trust in the process.” 

Time-Consuming Concerns 

Bernstein says that one challenge IROs face involves how some physicians are concerned that recruiting their patients for clinical trials would involve too much of the doctor’s time. “They’re 

very busy in their general practice, and they do not need one more thing for them or their staff to do. But the IRO makes it easier for them by reducing that administrative burden when we embed in their office,” she notes. 

Bernstein says that Circuit Clinical often will work with general practitioners. “There are many clinical trial opportunities in general medicine,” she explains. “Specialties ebb and flow based on what types of drugs are in development. For instance, COVID-19 trials and GI pipelines are very prevalent now, as is NASH (nonalcoholic steatohepatitis). Generally, one can participate in clinical research as long as there is a trial for their condition, and they meet the specific inclusion- exclusion (criteria) of a given study, but few are offered that care option.”

Bernstein also indicates that getting involved in a clinical trial would be a good learning experience for younger physicians. “Many newer physicians coming out of medical school don’t really know a lot about how to get involved in the drug development process. So they have an opportunity to partner with IROs and receive training on how to undertake clinical trials. IROs can bring that expertise to the table with training programs and access to trials, and bringing them on as investigators in existing trials,” she says.  

Circuit Clinical has developed ™, a ratings and reviews platform that helps patients seeking, considering, or already participating in clinical research. TrialScout provides peer-to-peer decision support and education, among other services. 

Advancing the Cause 

A number of companies are working to advance clinical research and daily health care integration. is an IRO that also offers clinical research services to health care organizations. Javara is attempting to optimize access to clinical trials for patients by deploying CRAACO in partner health systems. The company’s : 

  • Embeds staff and infrastructure to operationalize clinical trials. 
  • Connects biopharmaceutical and device research to healthcare organizations and physicians to address population health needs. 
  • Works with patients to positively engage them in their health management. 

With this approach, patients receive specialized care. Health care organizations realize value through better care for patients and contributions to advancing medicine. The pharmaceutical industry benefits from a reliable site services collaborative to expedite the drug development process.

For Javara and other IROs, the greatest has been the lack of experienced trial investigators. The IRO model responds to this challenge by attempting to train new investigators. There are other issues as well, such as making sure that the protocols match real-world health

care practice to facilitate enrollment and align with Food and Drug Administration (FDA) objectives. 

Meanwhile, is with physicians and healthcare communities to seamlessly integrate clinical trial execution into current workflows with the infrastructure and expert personnel needed for faster startups. Using IntElligo®, Elligo’s advanced technology platform, the company uses EHR data to transition more patients to CRAACO. Elligo matches study criteria and streamlines the process by automatically preparing patient data for submission and regulatory compliance. 

High-Touch Option 

At executives believe that participating in clinical research is a high-touch care option for both patients and providers. The company provides the expertise and the infrastructure to physician-researchers who want to participate in clinical research but need experienced research staff for support. Company include training and quality assurance, trial analysis and budget development, and technology management and infrastructure, among other services. 

is a part owner, along with , of , and has invested heavily to centralize and harmonize EHRs to facilitate finding researchers not only for CRAACO, but also for research as a value-based care option. Innovo Research is a provider-sponsored, provider-led network of accountable care organizations (ACOs) that utilize clinical research and trials as part of their population health strategy. Innovo Research aims to match patients with the appropriate clinical trial. 

CRAACO is an attempt to improve health outcomes for patients by giving them access to the latest therapeutics that address their condition. The effort is a patient-centric collaboration between patients, providers of care, pharmaceutical developers, and policymakers that can help optimize patient health outcomes while at the same time move drugs to market faster. But integrating clinical research into daily care is a fundamental challenge, and change will not come immediately, but rather will occur over time as efforts continue. 


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