By: Sean Khozin, MD, MPH
Nearly all of us need a hobby outside of our profession to recharge. For me, it is composing music. The joy I get from it comes not just from creating melodies, but also the mechanics of connecting seemingly disparate fragments of ideas into a harmonious composition. While each composition is different and there is no single approach to writing a piece of music, like a healthy body, a well-written composition is one that is balanced and in homeostasis. So, in many ways, I am fortunate that my hobby is so close to my profession: as a physician, my role is to restore disease-induced disruptions in physiological balance and as the CEO of CancerLinQ, my goal is to improve cancer care and research by connecting seemingly disparate fragments of real-world data into a cohesive understanding of the complex journey of patients. Capturing and quantifying the uniqueness of each patient’s complex cancer journey will be our focus for CancerLinQ® in 2022 and beyond.
In oncology, there is no one-size-fits-all approach. Take advanced non-small cell lung cancer (NSCLC), for instance. Before the days of targeted therapies and immune checkpoint inhibitors, our best option for first-line treatment was doublet chemotherapy, which is associated with an overall response rate of only about 30%. Based on a recent US Food and Drug Administration (FDA) analysis, this translates into a number-needed-to-benefit (NNB) of about 8: for every 8 patients we treat with chemotherapy, only one derives real benefit while nearly everyone treated experiences toxicities.
Today, with immune checkpoint inhibitors and targeted therapies, the NNB for patients with advanced NSCLC and validated predictive biomarkers is about 2: for every two patients we treat, one benefits. This is remarkable progress, but the goal of precision oncology is an NNB of one: all patients treated with anticancer therapies should benefit. Patients don’t fail our treatment. It’s our treatments that fail them.
It is the goal of improving the care of every single patient with cancer (the N of 1) that motivates us at CancerLinQ. Shortly after I joined the organization last year, we launched Project Renaissance to enable organizational transformation along three pillars: operational practices, product development, and technology infrastructure. Project Renaissance is divided into two phases, with the first phase involving a comprehensive organizational assessment centered on evaluation of current capabilities. The second phase, which we will be starting in the second quarter of this year, is a program to apply the lessons learned from the first phase to develop products and solutions that address the needs of our network of community practices and cancer centers. CancerLinQ’s new strategy involves creating products that advance the interests of our network in concrete and measurable ways, helping oncology professionals improve cancer care while thriving in an increasingly complex practice environment.
In 2022, in addition to the current suite of quality tools, we plan on delivering value to the network under three new categories of product development efforts: 1) tools to allow prospective data collection for registries and clinical research, 2) decision support tools to help oncologists optimize treatment decisions based on the individual attributes of patients, and 3) patient-facing applications to streamline patient triage and engagement. We will be developing some of these tools in partnership with other innovators for expeditious deployment and assurance of quality.
Our new strategy will build on the current foundation of CancerLinQ’s applications that have been utilized by cancer practices and researchers for years. This foundation is allowing us to develop a number of new applications for clinicians to choose from in CancerLinQ’s SmartLinQ™ platform. As a repository of smart technology tools, SmartLinQ™ will provide a suite of applications for clinicians and practices to improve patient care with greater precision and efficiency. Currently, one application already embedded in SmartLinQ™ is a pathway for practices to submit their measure scores to ASCO’s Quality Oncology Practice Initiative (QOPI®) Certification Program. Many practices have used SmartLinQ’s QCP Pathway for this purpose while several others have used the tool to design quality improvement initiatives or successfully claim at-risk reimbursement.
For researchers, CancerLinQ Discovery® provides sets of aggregated, de-identified real-world data on a variety of cancer types that can be studied to improve patient care. Today, we are exploring new models of federated research to accommodate a larger number of studies globally. The insights from these research efforts will be disseminated via publications and new applications delivered to CancerLinQ’s network via SmartLinQ™. CancerLinQ-supported studies help fill knowledge gaps left by clinical trials, including the impact of treatments in underserved populations that are traditionally excluded from clinical research due to systemic barriers to participation. For example, an analysis using CancerLinQ Discovery® data found that more than half of patients with early-stage breast cancer would be considered underrepresented or unrepresented in clinical trials due to age, comorbidity, or race. CancerLinQ’s scientific publications can be found here.
On February 10, 2022, FDA’s Oncologic Drugs Advisory Committee voted 14-1 that the results of a clinical trial in support of an immune checkpoint inhibitor are insufficient for US regulatory approval because the study was conducted in a single country with a homogeneous patient population. In other words, the committee concluded that the results could not be extrapolated to the US population due to lack of external validity. It is important to note that with less than 5% of patients with cancer participating in clinical trials, even clinical trials conducted in the US can suffer from the lack of external validity if they do not enroll an appropriately diverse patient population.
CancerLinQ’s commitment to unlocking insights from real-world data has been providing a window into the experience and outcomes of patients traditionally excluded from clinical trials. In 2022, we are stepping up our efforts to address inequities in access to clinical trials with a new effort dubbed TriaLinQ. With TriaLinQ, the CancerLinQ team is working on tools to extend the reach of clinical investigations to underserved communities, building on CancerLinQ’s existing data foundation to identify patients who are eligible for clinical trials and empowering their oncologists with the tools necessary to offer study enrollment in their own practices, close to their patients’ homes and without losing the therapeutic bond with their patients.
By keeping each patient at the center of our work and focusing on helping our participating practices and cancer centers succeed in achieving their mission, CancerLinQ’s new vision is a collaborative model designed to build practical technology solutions that transform cancer care and research by empowering oncologists, clinical researchers, and patients. I am excited about our new efforts and look forward to working closely with our ecosystem of practices and innovators in the technology and biomedical research communities focused on improving the lives of patients with cancer. If we haven’t already met, please do not hesitate to introduce yourself: firstname.lastname@example.org.