One Idea Worth Sharing.

OVN Insights delivers one clear, real-world perspective on what’s working and what’s not in oncology drug development.

A patient fighting multiple cancers is barred from a potentially lifesaving immunotherapy trial because they lack a “normal” lymphocyte count. Yet, a suppressed lymphocyte count is the expected, perfectly normal consequence of their prior treatments.

They aren’t excluded because of bad science. They are excluded because of a bad template.

In oncology drug development, we invest billions of dollars to advance groundbreaking science. But when it comes time to execute, clinical trials frequently break down in the details. The culprit isn’t the mechanism of action. It’s rigid, template-driven eligibility criteria that exclude real patients for non-clinical reasons.

This Isn’t a Scientific Barrier

We often assume trial accrual is slow because a disease is too rare or patients are unwilling to participate. But in many cases, we are artificially restricting our own progress. We are barring patients from clinical trials based on operational blind spots, not scientific necessity.

When designing clinical trials, organizations frequently rely on legacy templates rather than integrating real-world clinical reality. Protocols are drafted with criteria that make absolutely no clinical sense. Instead of questioning the necessity of these restrictions, teams accept them as standard operating procedure.

What’s Actually Happening

Across the industry, protocols are filled with restrictions that have been copied forward for years without being re-examined.

You might see a requirement for “Hemoglobin of 9 with no transfusions in the last twelve years” or a mandate for triplicate EKGs. When investigators push back and ask why these specific hurdles are included, the response from the sponsor is inevitably, “It’s on our template.”

Sometimes the blame is shifted to the FDA.

But in reality, it is a failure to update outdated thinking. If a drug doesn’t affect cardiac function, or if its potential to eradicate a tumor far outweighs its potential effect on hemoglobin, these rigid criteria serve only as bureaucratic roadblocks.

Why This Matters

When we design trials for theoretical, ideal patients, we ignore the reality of the clinic. The vast majority of cancer patients do not have pristine lab results precisely because of their disease and prior treatments.

Excluding patients from clinical trials for non-scientific reasons slows trial accrual, inflates development costs, and ultimately delays getting new medicines to market.

More importantly, it denies desperate patients access to potentially curative therapies for reasons that have nothing to do with their actual ability to safely participate in the study.

Where It Breaks in the Real World

Consider the earlier example of patients with multiple cancers. Being denied access to an immunotherapy trial because of an abnormal lymphocyte count is heartbreaking for both the patient and the physician.

As academic clinical investigator Dr. Jedd Wolchok points out, most cancer patients don’t have normal lymphocyte counts because of their prior treatments. Excluding them based on outdated checklists is, in his words, “nonsense.”

It is a massive operational failure that leaves academic investigators delivering devastating news to patients over a technicality.

What Needs to Change

If a template is standing between a patient and a trial, you need to “change your bloody template!”

Fixing this requires integrating academic clinical investigators into the leadership and strategy conversations before a protocol is published. Clinicians working directly with patients can provide the necessary context to ensure that eligibility criteria match the demographics of the real-world population.

We must strip away legacy requirements that do not directly protect patient safety or preserve the trial’s statistical integrity.

The Bottom Line

Great science cannot save patients if a flawed trial design prevents them from accessing it.

We cannot afford to let operational laziness dictate clinical trial eligibility.

Until we stop relying on rigid, outdated templates, we will continue excluding the very patients we are trying to cure.

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