Embedding Clinical Research into the Continuum of Care

Originally posted in the Clinical Researcher June 12, 2018

PEER REVIEWED

Jennifer J. Byrne; Jane M. Shen, PharmD; Amanda W. Wright

Clinical research is the frontline of medical innovation. Through research projects, scientists and physicians make medical breakthroughs that directly impact the lives of patients and their families. However, what many patients and physicians don’t realize is that when clinical research is integrated into the continuum of patient care, it represents a valuable care option.

When patient volunteers participate in clinical research, they get access to leading-edge research treatments or devices, generally at no cost, and a network of healthcare providers who are focused on making sure their overall experience is positive, and meets the highest quality medical standards. Such care excellence is a critical component of the clinical research experience for a patient volunteer. Study leaders are deeply invested in each participant, and go to great lengths to ensure trial volunteers adhere to strict care protocols. That translates to greater adherence, and often results in patients, as healthcare consumers, being more educated and invested in their care.

Such dedication to patient care doesn’t just benefit the researchers. Patient engagement has become an increasingly important measure of success in the healthcare space. Mounting evidence confirms the influence of patient engagement on improved health outcomes and on reduced costs.{1} This directly drives the coveted value-based healthcare delivery of improving the patient experience of care, improving overall population health, and reducing the per-capita cost of healthcare.

Participation as a Positive Experience

A recent study shows that people can be far more engaged in their care when participating in a clinical trial, perhaps because they see the connection between their participation and the greater good of the patient community. In this 2015 study, a series of phone surveys were conducted with 42 diabetic patients participating in an ongoing diabetes clinical trial. The results showed a surprisingly high level of patient engagement and satisfaction with their treatment.

Overall, the surveys show positive experience across all dimensions for clinical research participants, with significantly higher levels of satisfaction in many patient-important dimensions, such as access to care, efficiencies in care delivery, and qualities of care received from the research team. Fully 100% of respondents said participating in clinical research reduced the overall cost of their healthcare compared to traditional treatment options; and 95% agreed that adding clinical research improved their overall quality of care. These data points validate what we’ve long known—that patient volunteers generally have an overwhelmingly positive experience when participating in clinical trials.

Even more intriguing, all participants said that participating in clinical research improved their interest and/or involvement in their overall healthcare. In the free-text response, many respondents said they found that the trial experience motivated them to be more engaged in their care, and prompted them to educate themselves about their disease. They also felt the research team more closely monitored their status, and that the experience inspired them to be more focused on their health.

In an era in which treatment adherence is a significant challenge, these results should excite physicians, other providers, healthcare systems, and payers. Non-adherence is associated with higher rates of hospital admissions, suboptimal health outcomes, increased morbidity and mortality, and increased healthcare costs, according to the U.S. Centers for Disease Control and Prevention.{2}

Looking ahead, further research is needed to quantify the influence of integrated clinical research on adherence, along with patient satisfaction, population health, and cost. However, this and other studies{3,4} suggest that participation in trials can have a positive impact on adherence, and thus perhaps reduce the negative effect of this trend. Data from patients across several therapeutic categories at several value-based healthcare systems could generate further evidence supporting meaningful integration of clinical research as a care option.

Physicians and Research: A Collaborative Approach

The care delivery model, embedded within a patient volunteer’s clinical trial journey, brings tremendous shared value—not just for biopharma companies in collecting data, but in the outcome, experience, and cost to the healthcare consumer.

Despite these benefits, healthcare organizations have often ignored the value of integrating clinical research into the overall continuum of care—and that’s a problem. Low clinical trial participation exponentially increases cost of drug development and, more importantly, delays new solutions coming to market to meet unmet medical needs.

This attitude is exacerbated by the lack of collaboration between clinical research teams, physicians, and the broader healthcare organization. Physicians often view clinical research as transactional in nature, and not as an integrated part of a healthcare organization’s care options. This often results in trials conducted by investigators unbeknownst to the healthcare institutions employing them.

The impact of this disconnect cannot be overstated. When healthcare organizations fail to integrate clinical research into their portfolio of care options, it creates an environment where physicians may be hesitant to recommend patients to trials for fear of losing track of them. As a result, unless a physician is directly involved in the research, patients who would benefit from participating in a clinical trial typically do not learn about the opportunity.

Today, less than 1% of the U.S. population participates in clinical trials, yet 72% say they would participate if recommended to do so by their doctor.{5} Conversely, large quantities of clinical research study data that could be transformed by healthcare systems into actionable information used to analyze and improve population health are ignored. This reduces the healthcare system’s ability to deliver the highest quality of care based on the most current research, and reduces the impact of research spending.

At the same time, the clinical research environment is facing increasingly complex obstacles that could be alleviated through a more collaborative approach to care. Sponsors and clinical research organizations (CROs) are  increasingly looking to move clinical trials into settings that have the infrastructure and support of electronic medical records (EMRs) to drive efficiencies in trial delivery while expanding their potential patient pool.

The healthcare landscape is also changing, with a shift from physicians owning their own practices to physicians hired as full-time employees for healthcare systems. By 2020, an estimated 80% of all U.S. physicians will be employed by healthcare systems.{6}

Lastly, patients are becoming actively engaged in their healthcare, and there is increased development of new value-based payment models that emphasize higher quality at lower costs.

Spread the Word

These changes can be leveraged by taking a more collaborative and inclusive approach to clinical research as a care option; but to do that, we need to change the culture around clinical trial participation so that all the stakeholders in the healthcare continuum benefit. That begins with creating a more collaborative culture where researchers, physicians, patients, healthcare systems, and advocates have more opportunities to connect and educate each other.

One driver of change may be the Enhanced Clinical Trials Design Act, which took effect in August 2017 and strives to modernize the clinical trial process and provide more treatments and therapies to improve patients’ lives as an integrated part of the care continuum. The Act intends to reduce the barriers for all stakeholders to ensure access to research and the data associated are fully utilized to the advantage of the patient. It encourages conversations between the U.S. Food and Drug Administration, National Institutes of Health, key industry stakeholders, and Americans who participate in clinical trials, and the creation of a framework to facilitate further integration of research in the continuum of care.{7}

Laws alone will not be enough. To bridge the gap between healthcare and clinical research, we need to alter the dialog around what it means to participate in a trial, and engage healthcare providers in the conversations so they feel connected to the care their patients receive.

Even simple conversations with patients about the value of clinical research can change the way they think about participation. In a recent survey conducted by Greater Gift, we asked participants that attended a Hero’s Journey Art™ Project event held in Winston-Salem, N.C., if they would be willing to participate in a clinical trial. The project combined science and art to convey the importance of clinical trial participation and raise awareness of clinical research. Before the event, 25% of respondents said they were “probably not willing” or “not willing” to participate in a clinical trial and 40% said they were “somewhat willing.” After the event, the number not willing to participate dropped to 12%, and those who were somewhat willing rose to 60%.{8} Collectively, the data show increased willingness to participate following the event experience.

All of us, as healthcare consumers, need to be informed on these opportunities. That’s where healthcare industry organizations come in.

Breaking Down Walls

Healthcare organizations need to break down the barriers between clinical research and conventional treatment, and to create opportunities for physicians and their care teams to learn about and even participate in these care options. When physicians feel confident that a trial will benefit their patients, and that they can stay engaged in their care, they may be more willing to suggest clinical research within the menu of options.

Such integration can be accelerated using rapidly evolving healthcare technologies and other approaches that get at the core of infusing clinical research with everyday care:

• Predictive analytics can identify gaps in care and help guide pathways toward clinical research to fill those voids.
• Outcomes research can help chronic disease management and preventive health by leveraging continuous engagement in the community.
• Precision medicine technologies can help extract patient and clinical intelligence to guide personalized treatment via clinical research.
• Telemedicine addresses the issue of patient access and can help to fill gaps in patient care and engagement.

With the necessary healthcare and research interfaced platform, implementing a clinical research program can create the infrastructure needed to better manage care coordination—thus resulting in reduced cost of care and improved treatment decision making.

New technologies and partnerships have the potential to help build integrated networks and to support value-based healthcare delivery, offering potential for innovative organizations to drive change. Such partnerships may also enhance the trust placed in clinical research by both healthcare providers{9} and the public.{5}

Further, we need to create platforms to broadcast the data, and to share individual success stories highlighting how clinical research has changed the lives of patient volunteers who participate.

Often the media only focus on negative stories about clinical research, but the industry is full of extraordinary examples of lives transformed by clinical trial participation. Consider Emily Whitehead, who had a resistant form pediatric lymphoblastic leukemia and was out of treatment options when she joined a ground-breaking CAR-T cell therapy trial in 2012. Within three weeks of participating, she was in remission and has been cancer free ever since.{10} Similarly, after Carl Walker, a hemophilia patient who at one time required thrice-weekly blood infusions, participated in a gene therapy trial in 2011, he no longer needed any infusions—either preventative or as a result of an injury.{11}

For every life-saving example, there are hundreds of other stories of research volunteers who had positive clinical research experiences, felt valued by the staff, and, because of that engagement, were more invested in their care and maintained better adherence to their treatment regimen. We need to celebrate all of these stories, and to spread the message of what it means to participate and what clinical trials entail. We can encourage our social circles to consider participating and we can speak to our healthcare providers about potential opportunities.

Finally, the biopharma industry must do its share. For biopharma, a collaborative and integrated approach to clinical research touches on four areas of importance to the industry:

• Population health improvement: A common goal for all healthcare stakeholders.
• Patient advocates for research: With positive experiences, patient volunteers become advocates for clinical research, leading to greater acceptance and participation. Patient advocacy organizations also serve as a vitally important and influential resource, given the deeply entrenched and trusted relationships they have with their constituencies.
• Trial effectiveness: With the right engagement and strongly managed processes, trials become more effective.
• Trial efficiency and cost management: A collaborative approach to clinical trials can greatly improve the efficiency and speed of a trial while reducing costs.

Conclusion

All of the approaches touched upon in this article lead to improved patient experiences, based on high levels of engagement by all stakeholders, including physicians and organizations. Optimized support for patient volunteers and physicians and other healthcare providers, coupled with high-quality, standardized processes, allows the right physician to connect the right patient to the right trial. This improved patient volunteer matching reduces the frequency of screen failures, improves retention rates, and enables positive healthcare experiences.

Collaboration amongst all stakeholders—patient volunteers, healthcare providers, healthcare systems, drug developers, and policy makers—must be increased to better communicate the value of integrating clinical research into the overall continuum of care, and to further enhance public trust in, and patient engagement with, clinical research.

References

1. Laurance J, Henderson S, Howitt PJ, Matar M, Al Kuwari H, Edgman-Levitan S, Darzi A. 2014. Patient engagement: four case studies that highlight the potential for improved health outcomes and reduced costs. Health Aff 33(9):1627–34. www.ncbi.nlm.nih.gov/pubmed/25201668
2. Neiman AB, Ruppar T, Ho M, et al. 2017. CDC grand rounds: improving medication adherence for chronic disease management—innovations and opportunities. MMWR Morb Mortal Wkly Rep 66. https://dx.doi.org/10.15585/mmwr.mm6645a2
3. van Onzenoort H, et al. 2011. Participation in a clinical trial enhances adherence and persistence to treatment: a retrospective cohort study. Hypertension. https://hyper.ahajournals.org/content/hypertensionaha/58/4/573.full.pdf
4. Heaney L, Hicks W, Seetuthum R. 2013. Adherence in asthma: comparing clinical trials to the real-world. PPDI. www.ppdi.com/late-stage-asthma/Adherence-In-Asthma_PPD-White-Paper.pdf
5. Research!America National Poll on Clinical Research conducted in partnership with Zogby Analytics. 2013. https://www.elsevier.com/connect/poll-majority-of-americans-wouldparticipate-in-clinical-trials-if-recommended-by-doctor
6. CenterWatch. 2015. Integrated research partnerships build momentum. The CenterWatch Monthly 22(7). https://store.centerwatch.com/p-459-july-2015-the-centerwatchmonthly.aspx
7. S. 1048: Enhanced Clinical Trial Design Act of 2017. https://www.govtrack.us/congress/bills/115/s1048
8. Causey M. 2018. Patients emerging as increasingly important clinical trial advocates. ACRP Blog. https://www.acrpnet.org/2018/01/02/patients-emerging-increasingly-important-clinical-trial-advocates/
9. Mainous AG 3rd, Smith DW, Geesey ME, Tilley BC. 2008. Factors influencing physician referrals of patients to clinical trials. J Natl Med Assoc 100(11):1298–303. www.ncbi.nlm.nih.gov/pubmed/19024226
10. Children’s Hospital of Philadelphia. Relapsed leukemia: Emily’s story. www.chop.edu/stories/relapsed-leukemia-emilys-story
11. Gallagher J. 2011. Haemophilia gene therapy shows early success. BBC News. www.bbc.com/news/health-16107411

Jennifer J. Byrne (jbyrne@greatergift.org) is Founder of Greater Gift and CEO of Javara in Winston-Salem, N.C.

Jane M. Shen, PharmD, (jmshen@wakehealth.edu) is President of the Board of Directors at Wake Forest Healthcare Venture, a company based with the Wake Forest Baptist Medical Center in Winston-Salem, N.C.

Amanda W. Wright (awright@greatergift.org) is Executive Director of Greater Gift.