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Clinical Trials in Oncology: Why Patients Are Willing to Participate, but Rarely Given a Chance

 
, Medical Reviewer, Editor
Last reviewed: 18.08.2025
 
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10 August 2025, 15:29

Most people in the U.S. are positive about participating in cancer clinical trials, and when a doctor actually suggests it, more than half of patients agree. But only 7–8% of adults actually get into trials, most often because there simply isn’t a suitable protocol at their site, and if there is, strict criteria cut off about a quarter more. The message is simple and powerful: the key issue is access, not “patient reluctance,” and certainly not “patient distrust.”

Below is an analysis of a recent commentary in JAMA Network Open (Joseph M. Unger, 2025): what exactly is stopping it, why it is unfair and ineffective, and what can be done now.

Why participation is so important

Clinical trials are a bridge between laboratory science and real medicine. Today's research is tomorrow's standard of care. This is especially sensitive for oncology: new drugs and combinations appear quickly, but it takes time for them to reach a "regular" clinic. Participation gives the patient:

  • access to the latest approaches under the supervision of an expert team,
  • strict monitoring and structured supervision,
  • a chance to influence the treatment of future patients.

And the more representative the set, the more confidently doctors will then apply the results to all groups of patients—regardless of race, income, or place of residence.

Where 90% of potential participants get lost

Analyses over the past few years paint the same picture:

1. No protocol available on site
For ~56% of patients, there simply isn’t a suitable test available at their hospital. This isn’t a patient “refusal” — it’s zero chance to start a conversation.

2. Strict selection criteria
Among those who have a protocol, another ~22–23% are unsuitable (due to age, concomitant diseases, past therapy, laboratory values, etc.). This is the second “filter” that cuts off a quarter.

3. And if they talk, people agree
When a doctor actually offers to participate, 55-61% of patients agree. And this is true across racial and ethnic groups: no differences in willingness to participate were found in current data between black, white, Hispanic, and Asian patients.
So the idea that “minority patients don’t want to participate in research because they don’t trust them” is a myth. A much more truthful answer is that they are less likely to be offered because large industrial trials are physically located in large academic centers, far away and inconveniently located, and there is no “local” access.

Why is it also a question of justice?

The breast cancer survival gap between black and white women in the United States is a stubborn fact. If clinical trials are the gateway to cutting-edge treatments, then unequal access means unequal chances at better treatments now, not just “someday.” Inclusive enrollment isn’t just about “science”; it’s about equal chances at life.

System bottlenecks - and what to do about them

Here are the specific levers that work (and are already being partially implemented in countries and centers):

1) Expand the geography of research

  • Partnerships between academic centers and regional/hospital clinics.
  • Network protocols: one research center, many “spokes”—satellites.
  • “Decentralized” elements: home visits, mobile nurses, sampling at a local laboratory.

2) Soften and “humanize” the criteria

  • Revision of “automatic” exclusions (slightly reduced creatinine, controlled concomitant disease, HIV with suppressed viral load, etc.).
  • Inclusion of the elderly, people with comorbidities - those who are actually encountered in the clinic.

3) Make participation logistically possible

  • Transportation, parking, child care, time compensation.
  • Flexible visits (evening/weekend), telemedicine for consultations.
  • Navigators (patient navigators) who help you navigate the entire route.

4) Remove hidden financial barriers

  • Transparent coverage of routine care costs by insurance.
  • Clear compensation for the participant's unplanned expenses.

5) Speak the patient's language

  • Materials and consent in plain language, culturally adapted.
  • The role of the community: opinion leaders, patient organizations, real stories of participants.

6) Make tests more “real life”

  • Pragmatic design (minimum unnecessary visits and procedures).
  • Use of electronic registers and randomization "on the flow" (registry-based trials).
  • Real clinical outcomes (quality of life, time to next line), not just surrogates.

“What if people still don’t go?” — They go!

Two key facts to remember:

  • Patients are ready. If a doctor offers, more than half agree.
  • There is enough will to participate for all groups. The gap in recruitment in industrial "pivotal" studies (for example, the share of black participants is ~3% with an expected ~14%) is explained by the structure of access, and not by "unwillingness".

What this means for the patient and family - practical steps

  • Ask your doctor directly if there are tests available for you (locally and in nearby centers).
  • Ask to contact the research coordinator or navigator.
  • Find out what expenses are reimbursed and how to arrange transportation/TV visits.
  • If the criteria seem “on the edge,” ask your doctor to check the updated version of the protocol: criteria are often relaxed during recruitment.
  • Check with reputable registries (through your doctor): sometimes there are less resource-intensive observational studies or studies with infrequent visits.

The Big Picture: How to Start a Virtuous Cycle

Inclusiveness → more trust → higher participation → faster and more accurate results → accessible, effective treatments → even higher trust. This cycle already works where the system is rebuilt to suit the patient, and not the other way around.

In short: the number one obstacle is the lack of opportunity. Give a patient a real opportunity, and they will usually take it. So it’s up to doctors, administrators, sponsors, and regulators to expand access, simplify the path, and make participation convenient and safe for a wide range of people. That’s how we’ll get new, well-tested treatments faster—for everyone.

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