The question on the table

A cancer drug can shrink a tumor, delay progression, even extend survival, and still leave the patient unable to climb the stairs, focus at work, or sleep through the night. On paper, the trial succeeded. In the patient's kitchen on a Tuesday morning, the story may be more complicated.

That gap is exactly what the FDA put under the microscope this week. On October 15, the FDA Oncology Center of Excellence hosted its 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop (https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-workshop-11th-annual-clinical-outcome-assessment-cancer-clinical-trials-workshop-10152026), titled Measuring What Matters: The Patient Voice in Cancer Clinical Trials. After more than ten years of progress in patient-reported outcome (PRO) science, the agency asked a blunt question: are we truly measuring what matters most to patients?

Notably, most of the panelists weren't regulators or statisticians. They were patient advocates with their own cancer experience. One session looked at where current outcome frameworks fall short as newer therapies like CAR-T, bispecific antibodies, and antibody-drug conjugates change the treatment experience, survivorship lengthens, and the need for more frequent, real-time data grows. The other looked ahead to patient co-design, emerging technologies, and concrete next steps for sponsors and researchers.

Hitting the endpoint isn't the same as feeling better

Clinical trials are built around endpoints: overall survival, progression-free survival, tumor response. These are rigorous, measurable, and essential. But they answer one question, is the treatment working against the disease?, and leave another largely unanswered: what is the treatment doing to the person's life?

That second question is what patient-reported outcomes are for. A PRO is information that comes directly from the patient, with no clinician interpreting it first: how tired they are, how much pain they're in, whether they can work, cook, sleep, or think clearly. In 2024 the FDA finalized guidance on a core set of PROs (https://www.fda.gov/media/149994/download) for cancer trials, naming five to collect: disease-related symptoms, symptomatic side effects, overall side effect impact, physical function, and role function (the ability to work and carry out daily activities).

The guidance itself acknowledges the limit: a core set is a floor, not a full picture. Some outcomes that matter enormously in a specific cancer, such as swallowing or cognition, may sit outside it. And every added questionnaire adds burden for patients who are already exhausted.

Why this matters more every year

Here is the good news that makes the problem harder: people are living longer with cancer. As of January 2025, roughly 18.6 million Americans (https://pressroom.cancer.org/Cancer-Survivors-Increase), about 1 in 18, had a history of cancer, and the American Cancer Society projects that number will pass 22 million by 2035.

For many of those people, cancer is no longer a short, acute episode. It is a chronic condition managed for years on oral therapies, immunotherapies, and maintenance regimens. Fatigue, neuropathy, "chemo brain," anxiety about recurrence, and the strain of returning to work don't show up on a scan. They show up in daily life.

That is why the FDA workshop specifically asked what patients living with cancer as a chronic condition need measured beyond the acute treatment window, and how survivorship outcomes could be built into trial design. When the treatment lasts years, a quality-of-life snapshot taken every few months is a thin record of what the patient actually lived through.

The snapshot problem

Most PRO data in trials is still collected the same way: a standardized questionnaire, completed at a scheduled visit or on a set cadence, with fixed questions and fixed answer scales. That approach gives clean, comparable data. It also has blind spots.

• Timing. A bad week between visits can vanish by the time the next form arrives. FDA's 2024 guidance already recommends assessing more often in the first few treatment cycles. This week's workshop weighed going further, with high-frequency check-ins during the very first cycle.

• Recall. Patients are asked to summarize how they've felt over days or weeks, and memory smooths the edges.

• Fixed questions. A checklist can only capture what it asks about. The unexpected symptom, the new worry, the detail that doesn't fit a 1-to-5 scale often goes unrecorded.

• Burden. Long forms on a portal or tablet are one more task for people who are already tired. Missing data follows.

This isn't just a research nicety. In a landmark randomized trial led by Dr. Ethan Basch (https://www.mskcc.org/press-releases/real-time-patient-reported-symptom-monitoring-demonstrates-overall-survival-benefit), 766 patients receiving chemotherapy for metastatic cancer either used a web-based tool to report their symptoms, including from home between visits, with alerts sent to nurses for severe or worsening symptoms, or received usual care. Median overall survival was 31.2 months in the symptom-reporting group versus 26.0 months with usual care, a five-month difference. Simply listening to patients more often, and acting on what they said, changed outcomes.

What better measurement could look like

The direction the FDA is signaling points to a few clear shifts:

1 More often, especially early. Frequent check-ins during the first treatment cycle, rather than waiting weeks for the next scheduled form.

2 Beyond the treatment window. Outcomes that follow patients into survivorship and long-term therapy, where fatigue, cognition, work, and emotional health become the story.

3 Designed with patients. Co-design means patients help decide what gets measured in the first place, not just answer what researchers chose.

4 Lower burden. New technologies only help if they make reporting easier, not if they add another app, login, or 40-question form.

There's a natural tension here: more frequent, richer data usually means more work for patients. The way through is to change the format, not just the frequency. People are remarkably good at telling you how they feel when you simply ask them and listen. A conversation can follow up on an unexpected answer, notice when someone sounds worse than their score suggests, and capture the detail that a checkbox would miss, while still producing structured data a trial can use.

Where Cali fits

This is the gap Calico Care was built to close. Cali, our empathetic AI care assistant, calls trial participants between visits on the schedule set by the study protocol and asks how they're doing: symptoms, side effects, mood, and daily function, captured in their own words. No portal to log into, no form to fill out alone.

Because it's a conversation, Cali can do what a fixed questionnaire can't. When a participant mentions something unexpected, Cali asks a follow-up. Beyond what's said, it tracks signals like changes in engagement, sentiment, and lifestyle that a score alone can miss. Every call becomes structured data, logged automatically and surfaced to the study team in one view, so frequent check-ins add insight without adding manual work.

And Cali never makes clinical decisions. Anything concerning is flagged and routed to the right person on the care or study team, with every interaction fully auditable, HIPAA compliant, and available in more than 100 languages.

The FDA is asking whether trials measure what actually matters to patients. Part of the answer is asking patients more often, in a way that feels human, and actually hearing what they say.

Want to see how conversational check-ins could strengthen the patient voice in your next study? Book a demo with Calico Care (https://calendar.google.com/calendar/u/0/appointments/schedules/AcZssZ3v_5iWDIC19OppN3XXNJTJVlsyX86FnRGCyk5lew5I7-ecrxPemLFMySeFgCWOIwRBzrXDkN8c) and hear what a Cali call sounds like.

Sources

• FDA Workshop: 11th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop (Oct 15, 2026) (https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-workshop-11th-annual-clinical-outcome-assessment-cancer-clinical-trials-workshop-10152026)

• OncoDaily: Are We Truly Measuring What Matters Most to Patients? (https://oncodaily.com/science/fda-599504)

• FDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials (Oct 2024) (https://www.fda.gov/media/149994/download)

• American Cancer Society: Number of Cancer Survivors in the U.S. (May 2025) (https://pressroom.cancer.org/Cancer-Survivors-Increase)

• Memorial Sloan Kettering: Real-Time Patient-Reported Symptom Monitoring Demonstrates an Overall Survival Benefit (https://www.mskcc.org/press-releases/real-time-patient-reported-symptom-monitoring-demonstrates-overall-survival-benefit)

• Basch E, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. (https://doi.org/10.1001/jama.2017.7156) JAMA. 2017. doi:10.1001/jama.