Patient Engagement Is Mandatory at Our Table

The Bonnie Addario Lung Cancer Foundation has developed a registry that can serve as a repository for data on patients with lung cancer—a means to empower patients and assist care providers to deliver personalized medicine in a patient-centered manner.
Published Online: August 09, 2017
Bonnie J. Addario and Daryl Pritchard, PhD
PRECISION MEDICINE ENTAILS the consideration of individual patient characteristics so that doctors, working directly with patients, can develop the best treatment plans for them as early in their care as possible. Treatment strategies should consider the whole person, including their age, medical history, ethnicity, biological characteristics, and other factors. This involves using technologies such as diagnostic tests, molecular profiling platforms, and therapies that directly target disease-causing genetic mutations.

I see the profound impact of precision medicine on patients every day. In 2006, my family and I founded the Bonnie J. Addario Lung Cancer Foundation (ALCF). We started another nonprofit, the Addario Lung Cancer Medical Institute (ALCMI), in 2008. ALCF works with patients to support research and to advocate for innovative lung cancer medicines and treatments. Both the ALCF and the ALCMI facilitate, fund, and drive research. We work with thousands of patients and their families around the globe, providing free education and support programs, connecting patients with doctors and clinical trials, and funding innovative research.

A lung cancer diagnosis is grim—only 18% of patients survive the disease. In the United States alone, 450 patients die from lung cancer every day. Lung cancer is the top cancer killer of men and women, killing almost twice as many women as any other type of cancer in the United States. Responsible for 26% of all cancer deaths, lung cancer is the second leading cause of all deaths in the country.1

With the rapid pace of developments in precision medicine, I am excited about the potential to shift the paradigm on how we diagnose and treat lung cancer and save lives. Furthermore, in this era of personalized medicine, we have an opportunity to vastly improve clinical trial design, thereby fostering an environment for innovation that can lead to the development of even more novel treatment strategies.

In 2016, for the third year in a row, targeted medicines and diagnostic tests accounted for more than 20% of the new molecular entities approved by the FDA (Figure 1).2 A recent study sponsored by the Personalized Medicine Coalition and conducted by Tufts University found that 42% of all medicines and 73% of cancer medicines in development are potential personalized medicines (Figure 2).3

Patient Input in Clinical Trial Design

At the ALCF, we strongly believe that patients are our most important partner in clinical research. There would be no clinical research without patients participating in studies and donating their specimens. The traditional clinical trial design process overlooked patient input, which led to profound inefficiencies. Researchers often needed to scrap or redesign their clinical trials to address patient needs and circumstances. We have an opportunity at hand to vastly improve the process. Including patients in clinical trial design and giving them an opportunity to own their data provide a platform to streamline the process by getting it done right, arriving at the endpoints that matter most, and finding ways to most effectively improve health. We need processes for greater patient participation in clinical research. Now is the time to move from concept to practice, and lung cancer is a prime example of where it can work.

I advocate for the need to shift the way we look at clinical research. The current biomedical innovation paradigm, of discoveries moving from the bench to the patient, needs to shift its focus so that clinical researchers first take into consideration the patient and new discoveries move from the patient to the bench and then back to the patient. This will transform research to ensure it is patient driven and truly personalized.

Consider the example of Corey Wood. While attending the University of California, Berkeley, Corey was diagnosed with stage 4 lung cancer. A triathlete and marathon runner, she immediately began doing research about targeted therapies and genomic tests. Once her oncologists zeroed in on the rare genetic mutation that was responsible for Corey’s tumor, they treated her with targeted therapy. Corey now leads the normal life of a 25-year-old thanks to precision medicine. She is passionate about furthering research in the hopes that researchers can develop more effective targeted therapies. Corey owes her life to medical research.

Still, these new and more effective targeted treatments are not useful if we cannot get them to patients. Research and innovation in personalized medicine are surging, but its adoption into clinical practice is relatively slow. In most cases, doctors do not even discuss personalized medicine at the point of care. A recent public survey showed that only 4 of 10 people are aware of personalized medicine and just 11% of patients say their doctor has discussed or recommended personalized medicine treatment options to them.4

Another survey found that most healthcare organizations are unprepared to implement personalized medicine5 and some hospital systems may be placing implementation programs on hold.6 This lag is caused by novel challenges encountered by healthcare delivery systems as they adapt to the new treatments and practices associated with personalized care. What we lack are more patient-driven healthcare delivery approaches and processes that would ensure access to personalized medicine, including comprehensive genomic testing and multidisciplinary care.

Empowering patients to be more engaged in their healthcare through awareness programs and education on the promise of precision medicine would be a good start. The strategy should focus on:
  • Patient involvement in learning about the healthcare system
  • Improving patients’ engagement with their physicians
  • Shifting the control of individual genetic data to patients
  • Encouraging patient participation in the development of treatment guidelines and clinical pathways
Support for precision medicine and patient-centered research is strong, as indicated by several recent legislative initiatives and public policies. Patient-centered directives are included in the Affordable Care Act, and the recently passed 21st Century Cures Act focuses on involving patients in research and care design. The Precision Medicine Initiative, an effort to recruit 1 million volunteers to donate their genetic information for research aimed at finding more effective ways to improve health, and the Cancer Moonshot Initiative, an effort to cut in half the time it takes to discover new personalized cancer treatments, were authorized in the 21st Century Cures Act.

These policies underscore the importance of ensuring patients are receiving the appropriate diagnostic tests and personalized treatment. Lung cancer is not one-size-fits-all. Patients who feel they are not receiving the care they need can share the information with regulators by visiting www.mypatientrights.org.

Implementing Changes

So, what can we do to advance personalized medicine? Patients must have a seat at the table to provide valuable data to drive faster cures. This includes ensuring that there is appropriate patient-driven trial design, clinical trial participation, diagnostic testing, endpoint determination, and data aggregation. We can change the clinical medicine research ecosystem and adapt it to be more patient-centered. This will bring new treatments forward on a shorter timeline.

We need to ensure that community hospitals and physicians are appropriately engaging patients and promoting personalized medicine. The ALCF is doing this by designating hospitals as Lung Cancer Community Centers of Excellence, where patients are assured of multidisciplinary care, tumor boards, genomic testing, and early screenings in these facilities. We can conduct clinical trials at community hospitals so that patients do not have to travel hundreds of miles to participate in one.

The ALCF just launched its patient-powered Lung Cancer Registry,7 a place to gather and store detailed information for patients with lung cancer. The registry directly involves patients in the collection of their information, which allows medical professionals to quickly analyze data to improve patient care. By creating a centralized registry, patients, healthcare professionals, researchers, the pharmaceutical industry, and policy makers have open access to information. Programs such as these will ensure that patients are empowered to educate themselves about their disease so they can receive the best, most personalized treatments possible.
AUTHOR INFORMATION

Bonnie J. Addario is chair, Bonnie J. Addario Lung Cancer Foundation, Addario Lung Cancer Medical Institute.
Daryl Pritchard, PhD, is vice president, Science Policy, Personalized Medicine Coalition.

ADDRESS FOR CORRESPONDENCE

Daryl Pritchard, PhD
VP, Science Policy
Personalized Medicine Coalition
1710 Rhode Island Ave., NW
Suite 700
Washington, DC 20036

E-mail: dpritchard@personalizedmedicinecoalition.org

Bonnie J. Addario
Lung Cancer Survivor and Chair
Bonnie J. Addario Lung Cancer Foundation
1100 Industrial Road #1
San Carlos, CA 94070

E-mail: bonnie@lungcancerfoundation.org
REFERENCES

1. Cancer stat facts: lung and bronchus cancer. National Cancer Institute website. https://seer.cancer.gov/statfacts/html/lungb.html. Accessed July 10, 2017.

2. Pritchard D. Personalized medicine at FDA: 2016 progress report. J Prec Med. 2017:3(1):74-75.

3. The Personalized Medicine Coalition and PhRMA. Biopharmaceutical companies’ personalized medicine research yields innovative treatments for patients. Personalized Medicine Coalition website. http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/ pmc-phrma-personalized-medicine-investment-21.pdf. Accessed June 22, 2017.

4. Miller AM, Garfield S, Woodman RC. Patient and provider readiness for personalized medicine. Pers Med Oncol. 2016;5(4):158-167.

5. Survey: most healthcare organizations unprepared for precision medicine [press release]. Salt Lake City, Utah: Health Catalyst; January 20, 2016. https://www.healthcatalyst.com/news/survey-healthcare-organizations- unprepared-precision-medicine/.

6. Slabodkin G. Many healthcare organizations not preparing for precision medicine. HealthData Management website. https://www.healthdatamanagement. com/news/many-healthcare-organizations-not-preparing- for-precision-medicine. Published January 27, 2016. Accessed June 22, 2017.

7. Lung Cancer Registry website. https://www.lungcancerregistry.org/. Accessed June 22, 2017.
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