Copy-Paste Development Is a Hidden Industry Risk.

One Idea Worth Acting On.

A protocol is pulled from the archive.

Same eligibility criteria. Same monitoring schedule. Same endpoints.

The team moves fast. The filing goes in on time.

Then the real world responds.

Physicians question whether the endpoints reflect how they actually treat patients today. Payers challenge a value story built against a comparator that is no longer standard of care. Patients drop out at rates the enrollment model never anticipated.

The trial was efficient. The evidence it generated was obsolete before it was filed.

What's Actually Happening

The fastest path forward in oncology development often feels like reuse. If the template worked once, the assumption is it will work again. Eligibility criteria, monitoring requirements, endpoints, operational assumptions — carried forward line by line because removing anything requires justification and keeping it requires nothing.

As Dr. Jedd Wolchok, academic clinical investigator and contributor to Voices of Oncology, describes it: when investigators push back and ask why a requirement is still in the protocol, the answer is almost always the same. It is on our template.

"Change your bloody template," Wolchok says.

The problem is not speed. It is institutional complacency dressed as efficiency. Organizations are optimizing for the regulatory submission process of five years ago while the clinical landscape they are submitting into has moved on entirely.

Why This Matters

Cancer care evolves faster than any other therapeutic area. A protocol designed against the standard of care that existed at the time of its last version may be measuring the wrong comparator, excluding patients who are now routinely eligible, and collecting endpoints that payers and guideline committees no longer find compelling.

Each of those gaps compounds downstream. Slower accrual because the eligibility criteria filter out patients who should qualify. Higher dropout because the monitoring schedule ignores what patients can realistically manage. Weaker reimbursement arguments because the value story was not built against the current treatment landscape.

Terri Conneran, patient advocate and contributor to Voices of Oncology, is precise about the patient-level consequence: the industry must stop relying on copy-paste development and start evaluating the real-life implications of protocols on the patients sitting in clinic today — not the patients who sat in clinic when the original template was written.

Where It Breaks in the Real World

The triplicate EKG requirement that entered protocols a decade ago for a drug class with documented cardiac risk. Still present in protocols for drugs with no cardiac mechanism because nobody challenged it when the template was copied.

The hemoglobin threshold set against healthy volunteer reference ranges. Still filtering out oncology patients whose labs reflect prior treatment — the exact patients the drug was designed for.

Each line has a history. Most teams cannot tell you what it is. The template carries the authority of precedent without the justification that created it.

What Needs to Change

Every eligibility criterion, monitoring requirement, and endpoint needs one question asked of it before the protocol locks: does this still reflect the clinical reality of the patients this trial intends to enroll?

If nobody in the room can answer that question with current clinical evidence — not with "it has always been this way" — the line should not be in the protocol.

That is not a radical position. It is the minimum standard for generating evidence that will still be relevant by the time the drug reaches the market.

The Bottom Line

You cannot build the future of oncology on the templates of the past.

Reusing legacy designs may accelerate regulatory timelines. But it weakens real-world execution, damages payer relevance, and generates evidence about patients who no longer represent the population the drug will serve.

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