Oncology care is at a turning point, both in how care is delivered and in the number of treatments available to patients. There has been a wave of innovation in immuno-oncology, personalized medicine, and unprecedented strategic guidance from the FDA, all of which are helping to accelerate innovation in cancer care. While drugmakers have relied on real-world data (RWD) and real-world evidence (RWE) as an external control in clinical trials for years to advance drug approvals, we’re now seeing this information used to understand how these drugs perform in real patient groups outside of clinical trials. Beyond clinical research, RWE is also impacting clinical decision-making by giving physicians a better sense of how treatments could affect their patient’s health.

Industry Support for RWE
Even before drugs get to market, RWE is playing a substantial role in changing the regulatory approval process for therapeutics in the development pipeline. For pharmaceutical companies that continue to ramp up clinical research and development of new drugs, understanding and utilizing RWE can get the right drugs to patients faster and more efficiently. These companies are even beginning to receive extended approval for their drugs that are currently on the market based heavily on real-world evidence.

Clinical trials are time-consuming, expensive, and do not represent the broad patient population that will eventually receive these treatments. This isn’t anything new. It is a challenge the healthcare industry has faced for decades, even with recent technological advancements and precision medicine efforts. As cancer is increasingly stratified by molecular subtypes, soon it won’t be useful to exclusively rely on traditional clinical trial information to support regulatory decision-making. In the real world, physicians consider a wide variety of subjective and objective indicators to determine whether a treatment is working. Simply put, how you measure “success” in the real world is different than measuring “success” in a controlled setting.

The FDA has recognized this gap, and has been developing new frameworks to incorporate RWE into their review processes. In December 2018, the former FDA Commissioner Scott Gottlieb, M.D. announced that a key strategic priority for the FDA would be to appropriately use RWD to help improve regulatory decision making.

Gottlieb was passionate about restructuring the clinical trial process, specifically by using RWD as well as leveraging it to enhance the understanding of how therapies work to help accelerate the drug approval process. He believed there was an impetus to not only determine if a product is safe for its intended use, but also to identify a way to understand its long-term outcomes in patient groups after they leave the clinical trial setting. In a decision consistent with his passion for RWE, Gottlieb named Dr. Amy Abernethy to one of the FDA’s highest positions, Principal Deputy Commissioner for Food and Drugs. Abernathy, an oncologist and former CMO of Flatiron Health, has been on the front lines of cancer innovation for years, dedicated to making the best use of RWE to impact overall patient care.

Following Gottlieb’s resignation, Ned Sharpless took over as interim FDA commissioner in April 2019 and recently vowed to maintain Gottlieb’s approach and the FDA’s current course of action. Working closely with Abernethy, Sharpless has stated that he will continue to be committed to science-based decision-making and prioritizing the FDA’s efforts to incorporate real-world data sources for the benefit of public health.

Using Data to Enhance Precision Medicine
As there is no “user manual” for providing cancer care outside a clinical trial, precision medicine can play a vital role in personalized cancer care. Beyond clinical trial results, physicians have to rely on their own experience to determine what treatments they expect to have the best outcome for a specific patient. By organizing de-identified patient data, RWE can provide deep and accurate real-world clinical evidence in real time – allowing physicians to make a difference at the point of care, while ultimately reducing costs.

Using organized RWD allows physicians to compare their patients’ genetic makeup with others who are very similar to discover which treatments worked best for them. By leveraging the right data, physicians can begin to identify a patient’s appropriate treatment path as soon as possible. This data may also help eliminate costly treatments that haven’t been effective in clinically similar patients, helping drive down overall costs to the patient.

The Future of Oncology Care
EHRs collect mass amounts of critical patient information but across the healthcare industry – from healthcare organizations, physicians, payers, life science companies – most lack the ability to take meaningful action with this data and put it to its best possible use. RWE and RWD can make a difference by helping to determine the best course of treatment, particularly in the complicated field of cancer care. When we enable oncologists to see patient data clearly, we can make sure that everyone touched by cancer finds the right path to the right care.

Photo: pandpstock001, Getty Images

 

 



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