Increasing Patient Access to Cancer Research, Care, and Pharmacogenomics  

How can the latest insights in pharmacogenomics be folded into clinical cancer care? According to Dr. Jai Patel on our latest episode of People of Precision Health, it’s a matter of integrating data into clinical workflows, empowering patients with access to research participation and resources, providing clear and actionable results, and breaking down barriers that have made cancer research and care traditionally difficult. 

Dr. Jai Patel is the Chair of the Department of Cancer, Pharmacology, and Pharmacogenomics at the Atrium Health Levine Cancer Institute. His research focuses on translational and clinical pharmacogenomics and pharmacokinetics for anticancer therapies, as well as managing and mitigating cancer-related symptoms. Dr. Patel also serves as an associate professor at the Wake Forest School of Medicine and as a part-time palliative medicine clinical pharmacist. 

Watch the full podcast here:

Creating a Comprehensive Cancer Pharmacogenomics Program 

When Dr. Patel first started at Atrium Health’s Levine Cancer Institute, he was brought on to build their pharmacogenomics program. His team has built standard operating procedures and used metrics to effectively integrate pharmacogenomics into clinical practice for drugs with well-established guidelines. 

It has been important that his team have access to patients across the board and that his work does little to disrupt the workflow of clinicians. From translation to integration, Patel’s work has focused increasingly in establishing the utility of digital health and folding genomic data into the medical record that is user-friendly and accessible at point of care, as well as finding ways to provide this data to patients in a way that they can understand. 

Utilizing Digital Methods to Provide Access Regardless of Location 

Levine Cancer Institute’s founder, Derek Raghavan, MD, PhD, FACP, FRACP coined the term ‘cancer center without walls’ to describe how they provide better access to innovative research and quality care regardless of geographic location. Levine uses their hub hospital in Charlotte, North Carolina to better deliver trials and standard care to patients at its 25 supporting locations at hospitals spread across the Carolinas. This includes genomic and pharmacogenomic testing. The ‘cancer center without walls’ ethos has been made possible in large part to an interactive, electronic treatment pathway system Levine has created. 

The electronic pathway system contains information for clinicians on where trials are available, eligibility criteria, disease area, biomarkers that may be required, and more. While much of Levine’s research infrastructure is at its Charlotte hub, this system allows for clinicians to order testing and experimental drug to their regional sites for more remote participants. The genomics testing lab also gives clinicians a one-page summary of results (as opposed to a 30-page analysis of the results), allowing for genetic testing to be more easily actionable at point of care.  

Adapting this system to be well-utilized by clinicians took time to think through. One thing Dr. Patel considered, he said, is “When a new FDA-approved option is made available today, how quickly can we make an update to make sure our clinicians know immediately that that drug is available?” He noted that they needed to bypass email and other traditional communication to make information available in real time to clinicians when they are in the room with patients. The electronic pathway system provides clinicians with best practices for different cancer types and mutations, and/or recommends current trials open to enrollment for emergent therapies. If a patient agrees to participate, they are linked up with a clinical research associate on-site to help them consent and enroll. 

Accommodating for Increasing Genomics and Pharmacogenomic Data 

As genomics and pharmacogenomics data becomes more abundant, Dr. Patel noted that systems and processes need to keep up to aid care providers effectively. When describing a vision for this, he said, “A lot of this will be AI-driven. There will be multiple tools to use all the information in the EHR and continuously mine that information to find insights on what may work for a patient based on biomarkers, age, and other demographics to provide the best tailored options.” The data from a patient will be funneled back into the system, to create a feedback loop to continually inform better precision medicine over time.  

Educating Clinicians on Genomics is Key to Effective Patient Experience 

Pharmacogenomics involves a lot of education to ensure that patients understand what it is, which genes impact their ability to tolerate or benefit from specific medicines, and other factors. At Levine, patients may speak with nurses on the front-line or meet with a pharmacogenomics specialist for additional resources and education. Cancer genomics is even more challenging since clinical oncologists need to be able to understand and apply genomic information in real time. Levine has provided these tools to oncologists, so they have access to molecular tumor boards and other information in the medical chart as it becomes available. 

Dr. Patel noted a recent study in the Clinical Cancer Informatics Journal about the success of Levine’s clinical cancer genomics program in massively increasing the use of molecular profiling, enhanced patient engagement in trials, as well as an increased utilization of molecular profiling from African American patients. The success of the program has had a lot to do with the electronic treatment pathway’s ability to integrate directly into the clinic workflow with tools for interpretation, trial matching, virtual molecular tumor boards, and managing concerns regarding patient cost. 

Utilizing Distress Screening and Nurse Navigators to Connect Patients to Resources 

Levine’s use of digital methods to improve patient experience has also been used in implementing electronic distress screening. While it’s recommended in National Cancer Institute (NCI) and National Comprehensive Cancer Network (NCCN) guidelines, Dr. Patel said, it’s hard for every cancer center to do this with every patient. “We test over 20,000 patients per year on an electronic distress screener for pain levels, anxiety levels, depression, financial concerns, and in gauging interest for genomic testing and clinical trials,” he explained. These screeners can automatically trigger outreach for trials, financial assistance, testing, and other resources patients need. 

Levine has also been increasingly seeing the benefits of providing patient access to nurse navigators. Levine currently has over 30 nurse navigators who help patients through the entire cancer care journey with things like triaging for care, appointments, emotional support, and access to treatments and trials. Another study Levine published looking at large B-cell lymphomas identified similar survival rates for white vs. minorities because minorities are more likely to require and utilize these nurse navigators to help them on their care journeys.  

Breaking Down Barriers to Cancer Clinical Trials 

Dr. Patel noted that cancer research is becoming more pragmatic and inclusive to broaden eligibility criteria and focus on more ‘real world’ patients. Barriers like poor performance status or age, or logistical constraints like number of site visits and unnecessary blood draws, or digital considerations like allowing for eConsent, remote monitoring, and patient reported outcomes can all be examined and improved upon for more efficient trials for study teams and participants alike. Nationally, about 10% of patients are in trials, but it is Dr. Patel and Levine’s goal to have 20% participation. And with mechanisms like these in place to improve access, he sees this as a realistic achievement.  

Standardizing Cancer Pharmacogenomics to Support Patients Beyond Research 

Dr. Patel sees the next few years as a large-scale transition between single-gene reflexive pharmacogenomic testing to larger multigene panels. While many cancer centers are doing this, it is largely in research settings, which limits access to only participants in those studies. Routine clinical testing with multigene panels will become increasingly common, so this information can be easily accessed within the electronic medical record. “There really needs to be a concerted effort, and I think we’ll see this over the next few years, where all electronic medical records systems have the ability to house discrete genomic data, and for that data to trigger alerts any time there is a drug-gene interaction,” Dr. Patel added. In a large integrated system like Atrium Health, patients receive many types of healthcare. Standardizing the way that this clinical decision support is vital to moving toward more practical uses of pharmacogenomics and precision medicine across the healthcare continuum from primary care to cardiology, cancer, and other specialties. 

For cancer pharmacogenomics, Dr. Patel hopes to see something similar to the All of Us Research Program. He envisions a nationally accessible population oncology program with whole genome sequencing and paired analysis of a patient’s germline DNA for disease risk and pharmacogenomic recommendations. This can cascade into triaging to different subspecialties across the care continuum. Dr. Patel remarked that this kind of program will take time not just from an implementation perspective, but in terms of cost and reimbursement. And while major improvements in cost and coverage for testing are gaining traction, inconsistencies still exist. Dr. Patel is working with the organization STRIPE (standardizing laboratory practices in pharmacogenomics) to determine evidentiary thresholds for recommendations of testing, and to standardize messaging across regulatory, professional societies, clinical practice guidelines writers, as well as insurers. 

Balancing Standards and Innovation to Broaden Access to Pharmacogenomics  

The integration of pharmacogenomics research into routine clinical cancer care for patients means balancing the latest findings while staying in line with well-established guidelines. Providing a technological infrastructure for the efficient integration of insights surrounding gene-drug interactions continues to give clinicians like Dr. Patel and his colleagues at Levine Cancer Institute encouragement that clinicians can utilize pharmacogenomics in their day-to-day practice. 

Giving patients easier access to research studies in tandem with standards of care is vital to continue to feed insights into novel approaches and to provide access to innovative methods and medicines. As standards continue to evolve, there is a significant promise in pharmacogenomics to drive strides in personalized medicine in oncology, where timing is critical to patient survival and data can further bolster more equitable care. 

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