The hardest part of offering a trial Is sometimes just remembering there is one
Fifty-five percent of patients say yes when they're offered a cancer trial. The harder problem, and the one technology can solve now, is whether anyone remembers to ask.
By Shrujal Baxi, MD MPH
_A treating oncologist’s view on trust, opportunity, and why technology can help but can’t replace the human encounter._There is a moment in the clinic that every oncologist faces over and over again.
Picture a woman in her sixties, second-line metastatic disease, sitting in the chair with her daughter beside her. We have just finished going through her scans. She is holding the printout the way people hold things they don’t fully understand but know are important. And she asks the question every oncologist knows is coming:
“So what do we do now?”
In current practice, most of us have about twenty minutes allotted for this follow-up. This includes reviewing the results of the imaging and prepare for next steps. I have a standard-of-care regimen I can recommend and start next week, one I could describe in my sleep. And somewhere, maybe in my own institution, or maybe down the street, there is a clinical trial that she might be perfect for.
Whether she ever hears about this trial, let alone consents to participate, depends almost entirely on whether I present it during this clinical encounter.
That is the uncomfortable truth at the center of clinical trial accrual. Not patient reluctance. Not fear. Not mistrust, though that matters. The rate-limiting step is often a physician, mid-clinic, running behind, trying to remember everything!
The data have already settled the argument
For years the story we told ourselves in oncology clinical trials was that patients don’t want to participate in research. They were frightened of being experimented on, unwilling to be randomized, or that certain populations of patients in particular would decline.
The evidence suggests otherwise. Unger and colleagues pooled 35 studies covering nearly 10,000 patients who were actually offered a cancer clinical trial, both interventional and observational. Fifty-five percent said yes. Black patients agreed at rates statistically indistinguishable from White patients. When you ask people, most of the time they say yes.
The problem is upstream of the asking. The same group’s earlier meta-analysis of more than 8,800 patients found that for roughly 56% of patients, no trial existed at their institution for their cancer type and stage at all, and another 22% were ineligible for the trial that did exist. Structural and clinical barriers alone made participation impossible for more than three in four patients before anyone’s preferences were ever considered.
So the accrual problem is not primarily a persuasion problem. It is an availability problem, an eligibility problem, and an attention problem. Over the course of this series, we will address all of them.
This piece is about the third one, knowing about the trial at the right time, because it is the only one that lives entirely inside my twenty minute encounter with this patient. Even when a trial is open, at my site, actively enrolling, and she qualifies on every line of the protocol, she hears about it only if I know about it.
The relationship between patients and their physicians is critical
Here is what I would want anyone designing technology for this space to understand: when I raise a trial with a patient, I am spending capital accumulated over hard conversations, joint decision making, and aligned goals.
In addition to evaluating a proposed protocol, she is evaluating me, her oncologist. She is asking herself whether the person who told her the truth about her prognosis, who called her at home when her counts dropped, who knows her daughter’s name, is now steering her somewhere good. The recommendation carries weight precisely because it is not a recommendation from a system. It is from someone who has demonstrated skin in her outcome.
This is why the offer cannot be outsourced. A portal can tell a patient she may qualify for something. A call center can pre-screen her but neither automated solution can answer the question she is really asking, which is: do you think I should do this?
Opportunity is mostly a logistics problem in disguise
The reason good trials go unoffered is rarely ideological. It’s friction.
Oncology is ever more complex. There are more treatments, more diagnostics, new staging systems, molecular risk profiles and even new cancer diagnoses each year that we need to stay current on. There is more demand for documentation, more complicated order sets, and more billing requirements than ever before. Into that busy, high-stakes environment, now introduce clinical trials.
Even when I do think about offering a trial, the eligibility criteria can run numerous pages, and I need to know in one minute whether my patient’s prior chemotherapy exposure or her creatinine clearance of 48 disqualifies her. I need to know what additional tests she might have to undergo if we proceed down this path. Not to mention, whether the site is enrolling today or sitting on an administrative hold. Getting a patient excited about a clinical trial and then finding out that we can not even offer the spot, is a particularly difficult conversation that I have had to have over the years.
Logistically, I need to be able to answer basic questions she is likely to have. How many visits would be required of her, how much of it her insurance covers, and whether the schedule is survivable for someone who is still working and driving herself to appointments. Are their support mechanisms to help with costs of transportation and parking?
Generally, if I can’t answer those things quickly, I default. Not out of laziness, but out of the honest recognition that I cannot responsibly recommend something I can’t yet describe. Defaulting to standard of care is the safe move. It is also how eligible patients quietly never get asked to participate in studies.
Make that lookup fast, accurate, and trustworthy, and you change behavior. Not because you have convinced me of anything, but because you removed the reason I said nothing.
What could technology do?
I have been in the health technology space for too long to romanticize the solution. Technology can surface the potential trial options for my patients. What it cannot do is make the offer.
It cannot weigh her performance status against her stated wish to be at her granddaughter’s graduation in May. It cannot tell whether the exhaustion in her voice means she needs to hear about the trial today or in two weeks, after she has had a break to process her disappointing scans. It cannot read the daughter’s face and know that the real conversation is going to happen in the car on the drive home.
Matching is a computable problem. Judgment is not. And consent, real consent, not signature capture, is the byproduct of a relationship, not a workflow.
The solutions in the trial-enablement space that will win are the ones built by people who understand this precisely: they hand the physician a clean, credible option and then get out of the way.
The part that Lind does not forget
There is one more thing, and it is the piece most often left out of the pitch decks.
I, as the physician, will get the credit for enrolling a patient when I have done almost none of the real work. And the thing I am given credit for remembering was, in nearly every case, put in front of me by someone else.
The research nurse re-verified eligibility and caught the lab value I misread. The coordinator built the visit schedule around the patient’s weekly therapy sessions and spent 40 minutes on the phone with the sponsor about a protocol deviation. The pathologist pulled the block and got the biomarker back in time for the screening window. The pharmacist sorted out the drug interaction. The financial navigator figured out the travel reimbursement, without which she would have declined and everyone would have written “patient preference” in the chart. The regulatory coordinator kept the site activated through multiple study amendments and kept the system uptodate so the clinical research assistants had the most current protocols at hand. My clinic nurse noticed her mood had changed and told me before I walked in.
Trial accrual is a team sport in which one person happens to be in the room when the question gets asked.
Any technology that optimizes only for the physician’s time and energy, while failing to treat the coordinator, the nurse, the pharmacist, and the navigator and so many others as essential to success, will produce a lot of matches without moving the needle on accrual or trial completion.
What good looks like
I don’t need a technology that decides for me what study to offer. I need one that means I never again find out, three months later, that my patient would have qualified.
Surface the option early enough to matter. Make it credible enough that I’ll stake my relationship on it. Make the logistics visible so I can tell her the truth about what it will cost her. Then let the team do what the team does.
She still has to decide. That part was never ours.
Most of the time, when someone actually asks her, she says yes.
Sources: Unger JM et al. “‘When Offered to Participate’: A Systematic Review and Meta-Analysis of Patient Agreement to Participate in Cancer Clinical Trials.” JNCI 2021;113(3):244–257. Unger JM et al. “Systematic Review and Meta-Analysis of the Magnitude of Structural, Clinical, and Physician and Patient Barriers to Cancer Clinical Trial Participation.” JNCI 2019;111(3):245–255.