To meet the growing demands of the pharmaceutical industry, clinical research must overcome obstacles related to patient and investigator participation and retention. Most often, these challenges boil down to a lack of awareness and access to opportunities. In addition, clinical research must be mindful of the long-standing lack of diversity and inclusion, stemming in large part from continuing misconceptions and a legacy of mistrust. This cycle continues to be sustained by the same gaps in access, awareness and understanding. How does the industry address this overwhelming need in the face of such seemingly entrenched obstacles?
A major initiative developed to address these challenges within the clinical research industry is known as CRAACO—Clinical Research as a Care Option. Simply put, CRAACO is a patient-centered approach to clinical research that is about increasing accessibility so that participation is on the menu of patient care options. In this model, research is seamlessly integrated into the healthcare system, at the point of care, so that it is readily available to providers and patients.
Traditionally, research opportunities have been largely supported by large academic institutions and hospitals, often located in large urban areas. With CRAACO, clinical research becomes a routine care option for all patients, not the few with rare disease or in extreme medical situations. Participation in the study is offered by a trusted doctor to the patient, making it more widespread and accessible. When clinical research is incorporated into healthcare practice, there may be greater participation among underrepresented groups.
The clinical research experience surrounding the development of vaccines and treatments for Covid has shown us what is possible. We know that we can increase community awareness and participation in research and at the same time increase the ethnic diversity of the populations involved. CRAACO is the bridge that can bridge the gaps in awareness, access and participation in clinical research.
CRAACO benefits patients, communities, providers and industry
In clinical research, we must never lose sight of the fact that patients are volunteers. What do they get in return? The clinical research experience for the patient is highly sensitive and highly personal. Compared to standard care, patients in a clinical trial are seen three or four times more often. This means that patients have increased awareness and a better understanding of their health, leading to better adherence to treatment regimens. A clinical trial protocol by its very nature requires a high level of accountability on the part of all participants. During the process, we see positive changes in patient behavior that are further enhanced throughout their continued involvement.
When patients are more committed to their therapy within a clinical trial, this spills over into other aspects of their overall health, creating a ripple effect. CRAACO’s role in the healthcare system is centered around this key element. Population health and responsible care are about encouraging people to have choices about their health and to take better care of themselves. The goal is to engage patients in their care in such a way as to prevent illness, hospitalization, and readmission. There is a strong synergy between CRAACO and population health.
In 2015, a white paper was published around the CRAACO concept and launched the initiative. A key finding was that fully 100% of the patients studied said that participating in the trial improved their commitment to their own health. Of this group, 95% said they felt clinical research had greatly 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 few words about diversity
We have long known that there are differences in how groups respond to treatment, whether based on gender, age or ethnicity. Historically, these differences have not been adequately addressed scientifically. In trying to deal with a pandemic—a global health crisis—it has become abundantly clear in a concentrated, condensed period of time that people respond differently to diseases and treatments. As the industry works to create vaccines and treatments in response to Covid, it has really started to shine a spotlight on the fundamental differences and the fact that we need to think about representation. This is a problem that has always existed, but may have previously been underestimated.
Presentation is critical as industry strives to develop better treatments and then ultimately gain FDA approval and make them widely available. This information is paramount when it comes to doctors understanding how best to meet the needs of their patients.
Integrated clinical research
Regarding the challenge of recruiting and retaining researchers, appropriate infrastructure and support are key to the delivery of clinical research. The complexity of today’s clinical trial process requires an embedded approach where an integrated research organization supports and enables physicians and healthcare systems to conduct high-level, scalable clinical research.
Physicians value clinical research because it not only allows them to provide cutting-edge therapies to their patients, but also provides them with more data that they can use holistically to improve the quality of their care. Clinical research will continue to evolve toward an integrated, patient-centered approach as more healthcare providers embrace what is possible instead of the very narrow lane they previously occupied.
Most doctors are not in these large institutions, they care for patients in areas outside of metropolitan centers or academic medical centers. CRAACO offers patients access to cutting-edge technology that many of these populations have not had access to. This in itself creates an opportunity to better connect with these patients.
Clinical research as a care option is a means of connecting patients to 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 between stakeholders.
CRAACO offers a solution to the lack of participation and awareness, whereby participation in clinical trials is seen as another viable option of care for all eligible patients. By seamlessly integrating clinical research with clinical care, more patients and physicians will be able to contribute to the development of new treatments.
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