To meet the growing demands of the pharmaceutical industry, clinical research must overcome hurdles related to patient and investigator participation and retention. Most often these challenges come down to a lack of awareness and access to opportunities. In addition, clinical research must reckon with a long-standing dearth of diversity and inclusion, stemming largely from lingering misconceptions and a legacy of distrust. This cycle continues to be perpetuated by the same gaps in access, awareness, and understanding. How does the industry address this massive need in the face of such seemingly ingrained obstacles?
A major initiative developed to tackle these challenges within the clinical research industry is known as CRAACO—clinical research as a care option. Simply put, CRAACO is a patient-centric approach to clinical research that is about increasing accessibility so that participation is on the menu of options for patient care. In this model, research is seamlessly integrated into the health care system, at the point of care, so that it is readily available to providers and patients.
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Traditionally, research opportunities have been largely supported by major academic institutions and hospitals, often located in major metropolitan areas. With CRAACO, clinical research becomes a common care option for all patients, rather than the few with a rare disease or in extreme medical situations. Research participation is offered by the patient’s trusted physician, thereby making it more common and accessible. When clinical research is embedded in the healthcare practice, there can be more robust involvement among underrepresented groups.
The clinical research experience around the development of vaccines and treatments for Covid has shown us what is possible. We know that we can increase communities’ awareness of and involvement in research and at the same time, enhance the ethnic diversity of the populations involved. CRAACO is the bridge that can overcome the gaps in awareness, access, and participation in clinical research.
CRAACO benefits for patients, communities, providers, and industry
In clinical research we can never lose sight of the fact that patients are volunteers. What are they getting in return? The clinical research experience for a patient is very high touch and exceedingly personal. Compared with the standard of care, patients in a clinical trial are seen three or four times more often. This means patients have increased awareness and a heightened understanding of their health which results in better compliance with treatment regimens. A clinical trial protocol by nature requires a high level of accountability on the part of all involved. During the process, we see positive changes in patients’ behaviors which are further reinforced throughout their ongoing participation.
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When patients are more adherent to their therapy within a clinical trial it carries over to other aspects of their overall health, creating a halo effect. CRAACO’s role in the healthcare system is centered around this crucial element. Population health and accountable care are about encouraging people to have agency over their health and to take better care of themselves. The goal is to have patients engage with their care in such a way that helps prevent illness, hospitalizations, and readmission. There is a strong synergy between CRAACO and population health.
In 2015 a white paper was published around the CRAACO concept, and the initiative was launched. A core finding was that fully 100% of patients studied said participating in the trial improved their engagement in their own health. Of this group, 95% said that they felt clinical research had significantly or somewhat improved their overall quality of care. The opportunity for patients to participate in clinical research, offered and provided by their trusted provider, combined with self-engagement creates healthier communities.
A word about diversity
We have known for a long time that there are differences in how groups respond to treatments, be it sex-, age-, or ethnicity-based. Historically, these differences have not been adequately addressed scientifically. In trying to address a pandemic—a global health crisis—it became very evident in a concentrated, compressed period of time, that people were responding differently to illness and treatments. With industry working to bring forth vaccines and treatments in response to Covid, it began to really shine a spotlight on underlying differences and the fact that we had to think about representation. It’s a problem that has always been there, but perhaps previously understated.
Representation is critical when industry seeks to develop better treatments and then ultimately garner FDA approval and make them widely available. This information is paramount when it comes to physicians understanding how to best address their patients’ needs.
Integrated clinical research
When it comes to the challenge of investigator recruitment and retention, the proper infrastructure and support are key to allowing for the delivery of clinical research. The complexity of today’s clinical trial process requires an embedded approach, one in which an integrated research organization supports and enables physicians and health care systems to perform scalable clinical research at a high level.
Physicians appreciate clinical research because it not only allows them to provide cutting-edge therapies to their patients, but it also gives them more data that they can use holistically to improve the quality of their care. Clinical research will continue to evolve toward an integrated, patient-centric approach as more health care providers embrace what is possible instead of the very narrow lane, they previously occupied.
Most physicians are not in these major institutions, they are caring for patients in areas outside of metropolitan hubs or academic medical centers. CRAACO offers patients access to cutting-edge technology that many of these populations have not had access to. This in and of itself creates an opportunity for better connection with those patients.
Conclusion
Clinical research as a care option is a means of connecting patients with clinical research as part of their ongoing health care, located where they receive that care, and offered by their trusted provider. CRAACO aims to provide patients with access to relevant clinical trials and new treatment options, thereby improving outcomes, while strengthening relationships among stakeholders.
CRAACO offers a solution to the participation and awareness gap, wherein clinical trial participation is seen as another viable care option for all patients who qualify. By seamlessly integrating clinical research with clinical care, more patients and physicians will be able to contribute to the development of new treatments.
Photo: Warchi, Getty Images
Throughout his almost 30-year career, Scott Aho, MBA, Senior Director of Emerging Healthcare Partnerships at Javara, has focused on sales and business development roles in clinical research, commercial pharmaceuticals, and devices. Over the course of his career, he has been involved in the development and growth of organizations from the ground up, including strategic planning, operational excellence, and sales organization development.
Amanda Wright, Chief Development Officer at Javara, has devoted her entire nearly 25-year career to clinical research with a focus on effectively connecting patients and providers to clinical trials; serving in various roles across the site enterprise, including leadership roles in operations, patient engagement, business development and marketing. A great deal of her career has been centered on forging shared value strategic partnerships and collaborations that serve to innovate business processes, patient engagement, and predictive modeling. In addition to her professional work, Amanda has served as a community leader, holding multiple roles with Greater Gift, a non-profit 501(c)(3) organization founded in 2010 to celebrate clinical trial participation. Serving as Executive Director from 2013 to 2019, she remains on the Board of Directors as a strong voice for strategic program development and expansion.
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