The Hidden Work That Keeps AMC Trials Moving

By Dan Schell, Chief Editor, Clinical Leader

I’ll be honest; before this conversation, my understanding of how clinical trials operate inside a major academic medical center (AMC) was mostly theoretical. I’ve talked to plenty of sponsors, CROs, and community sites, but I’d never really spent time with someone who lives and breathes the AMC environment every day. That changed after a random LinkedIn connection with Paul Antaby, MHA, research administration analyst, material transfer agreements at MD Anderson Cancer Center. I saw where he worked, sent a note, and asked if he’d be willing to talk.

What followed was one of the more eye‑opening conversations I’ve had recently, not because of any single headline‑grabbing revelation, but because of how much invisible infrastructure exists inside an institution like MD Anderson. Paul’s role sits at the intersection of compliance, collaboration, and data stewardship, and it quickly became clear why AMCs operate so differently from community sites.

FROM RUNNING TRIALS TO GUARDING THE GATE

Paul spent more than a decade running clinical trials on site before moving into his current role in MD Anderson’s central office. Today, he works primarily on material transfer agreements (MTAs), data transfer agreements (DTAs), and data use agreements (DUAs), acting as a gatekeeper for anything leaving the institution.

“If a PI wants to activate a trial or transfer data or materials to another institution, it comes through us first,” he told me. “We review everything, make sure it’s compliant, and only then does it get off the ground.”

That oversight matters because MD Anderson is not just running its own trials; it is also a magnet for outside researchers looking for rare patient populations, specialized samples, or unique datasets. Paul and a very small team review hundreds of agreements every month, ensuring that any collaboration meets strict regulatory and ethical standards.

One of the biggest challenges, he said, is basic compliance. External researchers sometimes request data without having the appropriate IRB approvals in place, assuming that because MD Anderson collected the data, the responsibility stops there.

“A lot of people think, ‘You collected it, so it’s covered under your IRB,’” Paul said. “But if you’re going to analyze it, publish it, or build a project from it, you need your own protocol. Human data is protected, no matter where it goes.”

WHY DATA FROM AN AMC IS SO VALUABLE

As Paul described it, part of the friction around MTAs stems from just how valuable MD Anderson’s data can be. The institution sees patient populations that many other centers never encounter, especially in rare cancers.

“If someone is looking for a very specific population, they’re probably only going to find it through us,” he explained. “We see a tremendous number of patients, including rare tumors that other institutions might never see.”

That scarcity is exactly why external organizations are often willing to wait months for an agreement to be finalized. According to Paul, it is not unusual for an MTA to take 90 to 120 days, largely due to IRB timelines on the receiving side. Still, researchers wait because the data is worth it.

But that value also creates risk. MD Anderson places strict limits on how long data can be used, who can access it, and how it can be published.

“We don’t allow more than a year of use,” Paul said. “And we make it very clear: you cannot share our data with a third party, and MD Anderson must be credited on anything that’s published.”

COMPLIANCE ISN’T JUST PAPERWORK

What struck me most was how much of Paul’s job revolves around anticipating problems before they happen. Every agreement is reviewed line by line, including signature verification, protocol alignment, and even language that could restrict MD Anderson’s ability to publish its own findings.

“We’re very picky,” he said. “If certain keywords aren’t in the agreement, it’s not acceptable. We don’t want any language that handcuffs us or prevents us from doing our own work.”

All of this helps explain why AMCs are often described as having “red tape.” From Paul’s perspective, it’s less about bureaucracy and more about protecting patients, data, and the institution’s scientific integrity.

“Data is precious,” he said plainly. “It can be worth millions of dollars. That’s why we don’t take shortcuts.”

HOW TRIALS FEEL DIFFERENT INSIDE AN AMC

Our conversation eventually circled back to Paul’s earlier career as a clinical research coordinator, and this is where the AMC experience really diverges from what many sponsors are used to seeing in the community.

Recruitment, for example, is rarely the bottleneck. Patients come to MD Anderson in large numbers every day, often already seeking advanced or experimental options.

“We don’t usually rely on third‑party recruitment,” Paul said. “The traffic is already there.”

By the end of our conversation, what stayed with me was not just how complex AMC operations are, but how much of that complexity is invisible to sponsors and CROs. From the outside, it’s easy to see an academic medical center as slow or rigid. From the inside, it looks more like a massive machine designed to protect patients, data, and decades of institutional credibility.