Treating clinical research as a viable healthcare option presents benefits to patients, physicians and the broader research community. This approach helps to foster more patient-centric studies and increases the diversity of patients that have access to clinical trials.
In this post, we look at what clinical research as a care option (CRAACO) entails and how viable an option it is for patient healthcare.
When a group of industry experts gathered at the 2019 Bridging Clinical Research & Clinical Health Care Collaborative, the agreement was that connecting healthcare and research can be daunting. But that shouldn’t be a reason not to try.
After all the approach would improve engagement through a more patient-centric focus. It could be achieved, in part, through using AI to scour electronic health records to collect and gather data to match those patients that could benefit the most from the research.
The importance of data is obvious, they say, but it needs to be interoperable and easier to share with health organizations to realize its full value.
Elligo Health Research, an integrated research organization (IRO), has tried to make the reality of clinical research as a healthcare option more prevalent by partnering with Piper Jaffray Merchant Banking to raise millions of dollars of investment. The goal, says Elligo CEO John Potthoff, Ph.D., is to improve access to clinical trials so they can be used by patients as healthcare options.
The focus is also on trying to make clinical research more efficient through innovation, using clinical technology to increase the number of physicians and their patients participating in trials.
Elligo Health Research has also partnered with Women’s Health USA — a network of women’s health, obstetrics and gynecology practices — to help their patients access clinical research as a care option. The result of these partnerships is an increase in the number of patients being matched with clinical trials, says Chad Moore, president of Elligo.
Other partnerships include one between Javara Research deal and Wake Forest Baptist Medical in order to link clinical research services with health initiatives, explains PulsePoint CEO Sloan Gaon.
Javara has also collaborated with Tryon Medical Partners to offer sponsored outpatient clinical trials to Tryon’s patients at no cost to patients. Research and treatment areas will include internal medicine, endocrinology and dermatology. Javara CEO Jennifer Byrne says this will be a valuable means of integrating research and patient care.
For instance, the company says its partnerships and CRAACO focus will support physicians to integrate research and healthcare by embedding staff and infrastructure in clinical trials and helping patients throughout those trials to manage their health.
Using EHRs and electronic data capture systems, along with pseudonymization systems, can lead to integrated research and clinical care. While this approach is less about running clinical trials and more about accessing patient data, the finding is that routine healthcare data can lead to improved research insights, explain researchers published in the International Journal of Medical Informatics.
The study also shows this approach can allow reduced documentation time for each patient.
CRAACO is a simple concept: combine patient health and treatment with advancing clinical research. Any eligible patients could stand to benefit, says Hanne Van de Beek at digital patient recruitment and retention service provider Trialbee. Benefits include faster drug development and better patient outcomes.
But the current healthcare systems need to change by integrating CRAACO into the ecosystem, he adds. Currently, too few physicians and patients are aware of clinical trials and many are of the opinion that the experience will be a burden. There’s also confusion about combining research with patient care: Between 45 and 58 percent of doctors do not offer research as a care option.
Doctors and nurses, on the other hand, cite confusion about the referral process and lack of time and resources to evaluate patients’ eligibility for trials and to discuss treatments with them. These challenges can be overcome by generating awareness of trials and by developing patient trust in the entire healthcare system. Sponsors should therefore provide information to sources, using platforms patients trust.
Integrating clinical research and patient healthcare is a powerful motivation for many healthcare providers as they can participate in clinical trials to advance research. But it can come at a cost to routine operations at a clinical practice, explains Dr. Todd Johnson, senior vice president of digital research network at health services innovation company Optum.
So when it comes to measuring patient markers such as blood pressure or heart rate, disruption would not be significant. However, when unusual testing is required, such as detecting minimal residual disease in cancer, adding it to the workload of a regular clinical practice is often burdensome. Staff would need to invest more time and effort, which could affect the quality of care they offer patients.
Physician-investigators suffer from a lack of research time, training and resources and are likely to suffer from burnout. Those over the age of 35 suffer twice the burnout rate than early career clinical investigators, according to researchers at Clinics.
To help prevent this from happening, every institution would need to be capable of managing routine patient care as well as research activities. This means bringing in additional human resources and support and improved funding to facilitate patient recruitment, contracts and budgets.
Tampa lags behind other areas such as Columbus, St. Louis and Raleigh as clinical research designated market areas. This is because Tampa lacks a culture in which academic health systems produce clinical research. Research needs to be treated as a care option, says cardiologist Irfan Khan, CEO of patient recruiting services provider Circuit Clinical.
Health systems can better provide trials as care options when they prioritize those trials as part of Medicare and devote sufficient resources into developing the program. Such an approach provides health systems with opportunities and interest from academia, with research as care incorporated into non-traditional academic centers, private practice settings and large hospitals.
Nearly 20 years ago, 38.7 million people in the U.S. did not have health insurance but, with the Affordable Care Act, that number dropped to 28.2 million by 2016. Due to the recent repeal of the healthcare-for-all insurance mandate and “political turmoil” that number is down again, says Dan Sfera, cofounder and CEO of clinical research organization DSCS.
Further, many health insurance plans don’t cover customers for treatments and procedures.
When it comes to whether or not health insurance will cover participation in clinical trials, the answer usually is that it depends. Clinical trials support provider Science 37 explains that patients looking to participate in clinical trials will need to contact their insurer to determine and negotiate coverage for the trial.
Some factors that will affect the insurer’s agreement is whether the clinical trial site is in the insurer’s network. Quinlan says patients can, with help from the clinical trial team, determine what is and isn’t covered by the trial itself. Travel expenses, drug costs and follow-up clinic visits might all be covered, for instance.
Indeed these types of trial costs, including physician visits and laboratory studies, are often not covered for Medicaid customers, even though 20 percent of U.S. citizens rely on this provider for their health insurance, according to the American Society of Clinical Oncology. Medicaid is not federally required to cover certain clinical trial costs. This is not the case for all states but more than 42 million Medicaid patients are without this coverage.
The team at ASCO says that the Clinical Treatment Act would guarantee coverage to Medicaid patients in clinical trials to treat life-threatening diseases. Of course, it would also improve research quality, deepen the diversity of trial patients and reduce financial hindrances to participating in research.
While not strictly pertaining to CRAACO, there is a global shift underway by major pharmaceutical companies to modernize clinical trials, which includes providing patients access to their own data, which is compatible with the research-as-a-care-option approach.
Providing patients with their trial data empowers them and does not compromise the research, writes Dr. Andreas Koester, vice president and global head of Janssen Clinical Innovation. Benefits to patients include being able to use some of their data for other clinical trials should they drop out of the current research study. Plus, patients could choose to share their data for broader research goals, Koester adds.
The accessible data initiative falls under Janssen’s Global Trial Community project, with the goal to engage patients throughout the study process, even after the trial ends. Its relevance to the CRAACO discussion is that research-as-care would require this open approach of granting patient access to research data and using routine healthcare data to further research.