TrialSite has written extensively about the importance of clinical research as a care option, especially in therapeutic areas such as oncology where the standard of care for a particular condition may also include participation in a clinical trial. In part, TrialSite was founded to help drive awareness about research, but to do so in such a way that develops trust and engagement with an ever-growing audience. A lack of patient participation is a major reason why a majority of clinical trials get delayed and even fail. That’s right, even in the oncology field where novel advanced therapies, such as breakthrough immuno-oncology treatments, can save the lives of loved ones.
With a revolution occurring now across biomedical research, myriad investigational cancer therapies offer more hope than ever to help not only save and extend lives but also boost quality of life. But the reality is that less than 1 in 20 adult cancer patients ever enroll in a clinical trial. This is despite the fact that for at least two decades now the pharmaceutical industry, academic medical centers, and vendors have repeatedly not only studied the problem but come up with new solution after new solution. Yet the problem in cancer research persists. That is, the lack of cancer patient participation in research has remained much the same year after year.
What are the Barriers or Challenges?
Lots of study has gone into the topic of what the barriers or challenges are in involving more people in cancer research. Unger et al. picked this problem apart in 2017, sharing that a number of barriers to trial participation included structural, clinical, and attitudinal constraints, and additionally, these vary depending on one’s demographic and socioeconomic level. TrialSite frequently discusses the need to connect or link the patient’s primary provider in the referral process to clinical research. Especially in the field of oncology where research will be more often highly relevant, those health systems that connect care options with research potential provide the most advanced opportunities for patient life-saving opportunities.
Enter the Advanced Practice Provider (APP)
The advanced practice provider (APP) serves an ever more important role in health systems in America. Why? With increasing numbers of Baby Boomers aging, the need for more comprehensive care management, that is preventive medicine used to treat and anticipate chronic conditions, grows literally by the year. Of course, the shortage of physicians is well known thus the emergence of APPs, such as physician assistants, nurse practitioners, and others to serve this growing aging population. This APP role possesses advanced degrees as well as the qualification to embrace many activities typically the purview of doctors.
Role of APPs to Boost Community Involvement in Clinical Trials
As discussed by Erin M. Burns, PhD, MSPH, recently in OncLive, how can APPs help boost community involvement in clinical trials? Ms. Burns writes an important piece for OncLive that anyone interested in the logistics of oncology clinical trials should at least peruse. She makes the point that in large academic medical centers or other research institutions, the APP’s health care role is deeply embedded in the care workflow. As Ms. Burns points out, they “are factored into the standard regimen of care for oncology advanced providers (APPs).” But Ms. Burns asks about the community setting. She notes that a number of challenges or “barriers” in the community space exist, inhibiting community practices and their patients from more clinical trial involvement.
Growing Numbers of APPs in Oncology
Burns points out that the number of oncology practices employing APPs has grown from 52% in 2014 to 81% in 2017 based on data from the American Society of Clinical Oncology’s (ASCO) annual Practice Census. Apparently, a collaborative effort involving not only ASCO but also the American Academy of Physician Assistants, the Association of Physician Assistants in Oncology, the Advanced Practitioner Society of Hematology and Oncology, and the Oncology Nursing Society indicate that a total of 5,350 oncology APPs are now active in America, and that number could round up to about 7,000 imminently.
These APPs are involved with myriad care scenarios and in many states; in about half of all states, nurse practitioners are authorized to practice without oversight; and all states allow “prescriptive authority” for nurse practitioners.
Clinical Research as a Care Option
Ms. Burns shares that APPs in oncology are very active in helping to conduct clinical trials across trial sites, serving as principal investigators, study coordinators, and /or as monitors. A number of barriers keep them from more ubiquitous participation—Ms. Burns reports on these:
“Barriers include a lack of time, inadequate awareness of clinical trials, and underrepresentation on research committees. Recommendations for realizing the potential of APPs include research-related education, more complete integration as a member of the multidisciplinary cancer care team, and federal and state policy and regulatory changes.”
TrialSite principals’ experience with various health systems, hospitals, and clinics suggests Ms. Burns is on the right track here. With the removal of a number of hindrances, APPs could, over time, contribute to enabling an increase in the number of community cancer practices participating in clinical trials. This could lead to far greater patient participation in studies, offering far more study participants access to advanced life-saving therapies.
Call to Action: Follow the link to read Ms. Burns’ full article in OncLive.