Democratize the data to advance precision oncology

Stacy Hurt, a stage 4 cancer survivor, mother of a child with a nano-rare disease, and Parexel’s Chief Patient Officer, works with sponsors to ensure that patients are consulted and listened to from the earliest stages of drug development. She believes patients are critical to every aspect of decision-making in product development, from characterizing unmet needs and designing clinical trial protocols to defining which outcomes matter.

Patients are the ultimate end users of precision medicines and treatments, not investors, biopharmaceutical companies, healthcare providers, regulators, health technology assessment agencies, or payers. In today’s cancer clinical research environment, patients have unequal access to genetic tests to profile their cancer; they can’t customize how to retrieve and utilize their test results, and they can’t quickly identify which if any, clinical trials they are eligible for. 

Patients and society won’t reap the benefits of precision oncology unless we democratize this data, that is, make it available to the patients who need it when they need it. Here are three things we need to do:

1. Give patients equitable access to genetic testing

Genetic testing is the starting point of precision oncology; without it, patients cannot receive personalized cancer therapy. Yet just 6.8% of cancer patients undergo germline testing, with rates even lower among Asian, Black, and Hispanic patients, according to a recent study.¹ 90% of the genomic data currently used to predict individual disease risk is from people of European ancestry and may not be accurate for others.² 

Even under ideal conditions, testing is uneven. I lost my dear friend, Jim, to colon cancer. While attending an appointment with him, I asked his oncologist (who works at a major U.S. academic research center) for Jim’s biomarker test results. He explained testing “wasn’t necessary” because the results would not be “actionable.” Jim had Stage 3 disease at the time. Without his biomarker data, Jim could not even determine if he was eligible for a clinical trial. 

The oncologist’s assumption was flawed because the science of precision oncology is moving fast: between 2017 and 2022, the fraction of “clinically actionable” tumors increased from 8.9% to 31.6%.³ A significant challenge in introducing new classes of targeted drugs is that we don’t know the prevalence of mutations. Even if it doesn’t change every individual’s clinical course, widespread DNA sequence testing correlated with real-world outcomes could yield valuable insights for future treatments.⁴

2. Let patients use their health data as they wish

In 2021, the U.S. Department of Health and Human Services began enforcing a provision of the 21st Century Cures Act that gives patients access to their medical records and testing results “without delay.”⁵ Patients can receive their genetic test data before discussing it with their healthcare provider.

The move stirred controversy. The American Medical Association has argued that most patients (65%) want to speak with physicians before getting “life-changing” test results.⁶ However, another survey found that 95% preferred to get test results immediately via a patient portal, even if they were “abnormal.”⁷

Most patients cannot interpret results from a massive panel of dozens (or hundreds) of genes with abbreviations such as CDKN2A, PTEN, and BAP1. Some want to wait and discuss tests with their physician or oncologist, while others prefer instant, unfiltered access. Many patients still can’t get their longitudinal health records for a meeting with an oncologist to discuss treatment options.

A patient-centered approach to releasing cancer test results and other health records would allow patients to receive them via electronic patient portals when and how they prefer. We have the technology to individualize this process.

3. Provide an easily searchable database of clinical trials

For newly diagnosed cancer patients and their families, even those armed with genetic test results, the landscape of precision oncology trials is complex and chaotic. Few oncologists have time to keep abreast of hundreds of studies testing targeted therapies, and often, patients are left to search on their own.

A harrowing trio of articles by Bess Stillman, an emergency room physician whose husband is dying of squamous cell carcinoma, takes readers on a journey through the “broken, obtuse, and confusing” cancer clinical trial infrastructure.^8,9 She asks, “Why are we punishing the patients who make scientific progress possible?”

After her husband’s diagnosis, Stillman needed “a real-time, searchable database that matches patients to studies using EMR data and allows physicians to see what places are available and where.”¹⁰ She found that in clinicaltrials.gov, the default repository for clinical trial information, she could not filter and sort trials efficiently because of non-standard data entry and infrequent updating.

How long it takes to find a clinical trial can be a matter of life or death for patients, as disease progression affects their eligibility to participate. We have the data science expertise to standardize entry fields for clinicaltrials.gov and could update it more frequently. An efficient centralized database would help patients, oncologists, investigative sites, and sponsors. It is long past time that we had one.

We must flip the script to deliver truly patient-centered precision oncology

I envision a precision oncology clinical research universe in which every cancer patient has the following within days or weeks of diagnosis:

• Precise data about the genetic and metabolic footprint of their cancer
• A portable version of their longitudinal health records
• An accurate list of open clinical trials relevant to their condition
• The ability to get screened for eligibility quickly and remotely, if possible
• Routine travel reimbursement and other assistance to participate in trials
• Trusted relationships with their medical team to enable shared decision-making about treatment options

With a few practical improvements to current care pathways, we could achieve this vision, meet the need for urgency, and empower patients.

Contributing Experts