Currently, while just a fraction of the general population participates in clinical research, 72% say they would participate if recommended to do so by their doctor, according to a Research!America National Poll.
“Lags in patient accrual delays lifesaving, life-enhancing new therapies getting to millions in need,” said Jennifer Byrne, CEO of Javara.
However, research is not only difficult but extraordinarily time-consuming. This, at a time when physician burden has increased following the conversion to electronic health records (EHR), resulting in primary care physicians spending nearly two hours on EHR tasks per hour of direct patient care, according to recent reports.
Compounded with the increasing complexity of clinical trial requirements, discretionary time for research has waned, noted Byrne.
On top of this, research is, more often than not, a cost center to a health system rather than a source of positive cash flow. Top tier systems have consistently reported that the subsidy on clinical trials is in range of 25-35 cents on the dollar, said Byrne. Why? Selecting the wrong trials.
“If you don’t randomize a certain number of patients per trial, you likely will lose money given the fixed cost nature of the clinical research infrastructure,” she explained. “Also, oftentimes, clinical trial activities and resources are siloed at the department level without natural alignment to share resources and optimize utility of resources.”
In addition to stressed resources within health care, Byrne also noted the significant shortage of clinical research professionals. It is estimated that there are between 12,000 and 20,000 fewer clinical research professionals than what is presently needed, she said.
Historically, there also have been low levels of research literacy not only at the patient level, but within the health care workforce. As a whole, the pharmaceutical industry also is challenged with distrust and skepticism, with many viewing the motivation for research as not for a patient’s benefit, but for the data needed to gain commercialization opportunities.
These challenges, among others, have left research on the periphery within the framework of the health care system.
Creating shared value
Promoting clinical research as a care option is one way to address these challenges and poses benefits for patients and health care systems alike.
“Universally, health care systems are looking for better ways to decrease cost of care, improve outcomes for patients all while creating a much more satisfying patient journey,” explained Byrne.
Health care systems committed to transitioning to value-oriented care can leverage clinical trial offerings as a way to better engage and empower patients, she said. Subsequently, reducing costs and improving outcomes while providing a better experience to the patient.
“If health care systems do not figure out how to better integrate clinical research within the menu of options for the patients for whom they serve, other research pathways may threaten the health system’s market share,” said Byrne, noting the emergence of the virtual trials model, which goes outside the system directly to the patient.
The best way for the industry to “get the ball rolling” on patient centricity is to be more intentional as it works with healthcare providers to transition patients into trials and out of trials. At the same time, ensuring that the insights resulting from any particular patient will be made available and used for the ongoing benefit of that patient, Byrne explained.
The bi-directional data flow of lab tests, study results, and other data insights are all helpful to the ongoing wellbeing of the patient, she added. Additionally, knowledge gained from research also enables the system to better support and treat its larger patient base.
“Getting more people to participate in clinical research expedites the drug development process and ultimately brings medicines to the market faster,” said Byrne, “in turn, improving population health in the long run.”