Friday, December 11, 2020

How Real-World Data is Helping Speed Oncology Drug Development

Today’s guest post comes from Sarah Alwardt, Vice President of Operations at Ontada.

Sarah describes how historical patient information can be used in current and future clinical trials, often eliminating the need for new trial participants. She also introduces us to Ontada, a new McKesson business that uses technology, real-world data, and research capabilities as a way to accelerate innovation and improve cancer therapies.

To learn more, visit the Ontada website.

How Real-World Data is Helping Speed Oncology Drug Development
By Sarah Alwardt, Ph.D., Vice President of Operations, Ontada

Clinical trials are designed with very specific protocols, including the number of participants needed to complete the trial. Finding enough patients who meet the criteria for a clinical trial can be challenging even in the best of times. In the midst of the pandemic, it’s even more difficult to enroll patients if in-person interactions are risky, or if one of the people involved is in quarantine. Simply traveling to a hospital or doctor’s office where the trial is being administered could put a patient at increased risk of contracting COVID-19.

Fortunately, data gathered from clinical trials is just one of the tools researchers can use to evaluate the benefits of much-needed cancer drugs in development. Additionally, real-world data (RWD) is information collected as a matter of course during a patient’s treatment—including, in some cases, the very same data a clinical trial would collect.

In cancer research, this data could include diagnoses, disease stage, cancer progression, treatment and reactions to medications. It can be gleaned from electronic health records (EHRs), insurance claims, and even mobile devices and fitness trackers. Of course, where these forms of data constitute “protected health information”, researchers only use fully de-identified—or anonymized—data to maintain patient privacy.

Analyzing RWD yields real-world evidence (RWE), which is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. Both types of information offer vast promise, something the Federal Government recognized when the 2016 21st Century Cures Act allowed the use of RWD and RWE to support FDA decisions about new medical devices or drug indications. Leveraging RWE is a smart option since the medical research community views it as an effective and necessary supplemental tool to push research forward.

At Ontada, our team of data scientists and oncology experts help life sciences companies leverage RWD and insights to accelerate innovation and improve cancer therapy. As a market leader in RWE, our proud legacy includes the first synthetic control arm used in an FDA regulatory approval for an oncology therapy.


Say a biopharma company has a new drug that targets a rare mutation in cancer. It’s ready to be tested in a clinical trial of 100 patients who will be compared with another 100 who received an older, standard-of-care medication.

For example, if the only patients eligible for a trial are those with the specific genetic mutation the drug is designed to target, it’s very hard to get enough patients to do a prospective randomized trial. That’s where a standard-of-care trial comes in. In this type of trial, enough past patients exist to assemble a historical control group. These anonymized patients have already been treated with the standard-of-care medication, so data collected during their care, which is easily gathered from a practice’s EHR, can be used in the trial.

These patients’ outcomes—how their cancer responded or how long they lived—can then be compared with those of the 100 counterparts who are currently receiving the investigational drug. Statistical methods can ensure the two groups are reasonably comparable. The resulting information can be enough to convince regulatory agencies that a new therapy is safe.

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Precision medicine—an approach in which an individual’s genetics, environment and even lifestyle are factored into their treatment—is another area that has benefited from the use of RWD and RWE.

Imagine you’re an oncologist with an elderly patient whose cancer has a rare mutation, one you’ve seen only a few times in your career. How will that cancer respond to standard treatment? After all, no clinical trial has examined this rarefied group of people.

That’s where RWD can come in and impact patients at the right point of care. You can use an EHR, like Ontada’s iKnowMed™, to gather the deidentified records of patients who share the same mutation, then examine how they responded to a particular drug regimen. Did they experience complications? How long did it take their cancer to progress?

Real-world data can help biopharma companies determine those additional factors including the comorbidities that could play impactful roles in either the effectiveness of the drug or the overall outcomes a patient might experience.

At Ontada, we believe that RWD and RWE supports life sciences innovation by accelerating the impact of cancer therapies—from early clinical development to drug commercialization and post-launch activation of insights. Even with the countless disruptions COVID-19 has caused, RWD offers a path —both for clinical trials and for the rapidly expanding horizons of precision medicine.

To learn more about Ontada, please visit our website.

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