14 Sep Q&A with Edward Kim, Atrium Health
In addition to his current role, Edward S. Kim is Medical Director of the Clinical Trials Office and the Donald S. Kim Distinguished Chair for Cancer Research at the Levine Cancer Institute, Atrium Health in Charlotte, NC. Dr. Kim was previously at UT MD Anderson Cancer Center in Houston, Texas where he was a tenured Associate Professor of Medicine, Chief of the Section of Head and Neck Medical Oncology and Director of Clinical Research Operations in the Department of Thoracic/Head and Neck Medical Oncology. Read his full bio.
Interview with Edward Kim, Atrium Health
Q: What are some of the challenges the industry is facing and how can we overcome them?
A: There are several challenges which include starting with the patients who we see and treat. They are our most precious resource for information and the center of all of our initiatives to improve healthcare. Establishing platforms that are nimble, easy to use and analyzable are the challenges. The electronic health record has not been a reliable data tool. PDFs of genomic reports do not serve as easily analyzable data. Finally, how best to use this information, organize and analyze, for patient directed care is the final and most important challenge.
Q: What approach is the Levine Cancer Institute, Atrium Health in Charlotte taking to overcome these challenges and addressing the internal needs of data integration for data interpretation?
A: We have several efforts to organize our existing data and collating the ever-increasing incoming data. We have developed a program and data warehouse that receives the direct molecular data (various sources) and is able to match patient molecular data any clinical trials we have or to targeted therapy. These results are discussed at our weekly molecular tumor board.
Q: What are some of the complexities of interpreting data at the point of care?
A: Providers may struggle with the interpretations or the clinical significance of mutations/alterations that appear on commercial genomic reports. This adds to an already complex patient. Our weekly molecular tumor board allows providers to seek real-time counseling and opinions on these cases.
Q: Clinical Genomics will eventually be part of clinical care. How much of the “genomics approach” is now part of routine oncology care at Atrium Health? What are some of the challenges specific to genomics data that we still need to overcome?
A: At Levine Cancer Institute, we worked early to standardize processes that allowed our providers to accurately order and receive genomic testing results. This is necessary in order to deliver precision medicine, especially in regional sites and not just the main center. Our EAPathways system has allowed this type of process to scale across our regional network as it has grown from 15 sites to 26 sites in less than 5 years.
Q: The Levine Cancer Institute has created an electronic clinical pathways tool, Electronically Accessible Pathways (EAPathways), with the purpose of providing standardized, evidence-based, continually updated clinical pathways for all LCI network providers. Can you provide an example that demonstrates its usefulness? Who can access it and for what purpose?
A: Our EAPathways is an internally developed product which allows providers to practice up-to-date precision medicine at their point of patient care. This program is accessible via the web or our HER system by nurses, pharmacists, advanced practice providers and physicians. The pathways not only outline our standard of care treatment, but also utilize shared documents, alerts regarding clinical trials, accessing patient services such as genetic counseling and our molecular tumor board. We can add new drug approvals in minutes, new studies in minutes, as well as edit our pathways in near-real-time. Our clinical trial enrollment at Levine Cancer Institute has consistently been balanced between enrollments at the regional sites and our main site (50-50). Our nimble pathways allow general oncologists to practice subspecialty medicine in the region.
Q: Dr. Kim, you are also the Medical Director of the Clinical Trials Office. What is your current involvement in clinical trials design? What are some of the most promising new approaches to increase clinical enrollment and overall improved clinical trial design?
A: Trial design continues to evolve over time as drugs and targeted therapy become more prevalent. Our ultimate goal is to maximize patient opportunity to participate in clinical trials. I am still very active in helping write and design studies which may expedite patient enrollment. Designs have become more adapted as molecular targets and drugs have been incorporated. Early phase studies will now assess more patients at a single time (eg 6) vs traditional 3+3 designs, as well as expand quickly into specific cohorts to further study the potential drug efficacy.
Q: There are a number of unmet clinical needs not addressed by current methods when it comes to proper therapy selection and disease management. How can these needs be addressed and how will and can precision medicine help?
A: Precision medicine utilizes genomic results to specifically recommend appropriate therapy for patients. It is always preferred to treat patients with the best drug earlier. Identifying unique characteristics of the tumor will help guide effective therapeutic options.
Q: The Levine Cancer Institute (LCI) has an active role in the TAPUR study, the first ever clinical trial conducted by ASCO. What is the significance of the TAPUR study and what is LCI’s role in it? Are there some exciting findings you can share with our readership?
A: Levine Cancer Institute was one of 3 original pilot sites for ASCO’s TAPUR study and I serve as the chair of the steering committee. The study is pragmatic and tests approved drugs in unapproved indications in order to assess efficacy in off-label subsets of patients. Providers were already practicing medicine using genomic reports and trying to find and treat patients with off-label drugs. However, data reporting was not typically performed as much of the experience was anecdotal. TAPUR allows physicians to offer patients study drug and provides patients with opportunities to be treated with biological drugs. TAPUR has proven feasible as its enrollment overall has exceeded expectations (over 2000 patients screened). Results (both positive and negative) have been reported in timely manners at national meetings and journal publications.
Q: Dr. Kim you have two roles at the upcoming PMWC 2020 Silicon Valley conference – You are part of the panel “New Approaches to Clinical Trial Design and Enrollment” and you will speak in the “Complexity Of Interpreting The Data At The Point Of Care” session. Can you touch upon the importance of these two sessions? What are you expecting PMWC attendees will walk away with from the PMWC 2020 Silicon Valley conference? What are some of the call to actions that we as a community should focus on?
A: PMWC is a personal and immersive meeting which allows frank discussion on important topics in the field of precision medicine. The topics are timely and allow participants to learn about individual experiences which may apply best into their work or practice. I feel honored to participate in PMWC 2020. The panel “New Approaches to Clinical Trial Design and Enrollment” will inform participants of our efforts to modernize eligibility criteria in clinical trials. Enrollment into clinical trials hovers around 5-8% of patients. This is due to the number of eligibility criteria that clinical studies have listed in the protocols. As these criteria were developed for patient safety, they have evolved into excluding the real-world population and more so a narrow population of patients. ASCO and Friends of Cancer Research in collaboration with NCI CTEP, FDA, Industry and patient advocates have changed the criteria to be more streamlined and scientifically justifiable, rather than “blanket” exclusions.
The topic of “Complexity of Interpreting the Data at the Point of Care” will further highlight our work at Levine Cancer Institute and how we have been able to effectively engage our regional site providers to offer patients participation in clinical trials. Through our EAPathways system, regional sites are aware of clinical trials, their status (open vs closed) on a daily basis and contact with study coordinators electronically. This has facilitated our teams to discuss and enroll patients at higher rates than national averages.