Behind the Scenes: Meet the Teams Connecting ​the Countless Dots of Clinical Trials

"COG's operational teams work closely with our scientific committees to take their research questions from ideas to reality."

This is the second installment of a Behind the Scenes series about how Children’s Oncology Group clinical trials work.
The first article opens in a new tab focused on how a research idea becomes an actual trial. 

​This story delves into the critically important and complex work that members of COG’s operational teams do to develop, launch, and run trials that move the science of childhood cancer forward so more kids can lead long, thriving lives. 

Every day, thousands of Children’s Oncology Group (COG) researchers are hard at work running clinical trials — fueling our mission to cure and prevent childhood and adolescent cancer through scientific discovery and compassionate care.
 
Behind the scenes, there’s crucial work happening to ensure every COG trial is safe for patients and stands the greatest chance of answering scientific questions with clear and compelling data.

Who does this work? Protocol Coordinators and Research Coordinators on COG’s operational teams who collaborate from start to finish, connecting countless dots to make sure the research meets stringent standards for patient safety and leads to meaningful insights.
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Protocol Coordinators: Building the Roadmap for a Clinical Trial

Protocol Coordinators play a vital role in getting clinical trials up and running opens in a new tab. Their job begins when a study committee generates the first of many documents that lay the groundwork for a clinical trial: the concept summary.
 
“As soon as a concept summary lands in our inbox, we are essentially the herders of that idea until it becomes a full-blown protocol,” says COG Senior Protocol Coordinator Melina Chanthanouvong, MPH.

From that point forward, the concept takes incremental steps forward, becoming more detailed at each stage of review and approval by multiple committees inside and outside COG, until it becomes a protocol, the all-encompassing road map for a clinical trial.
​Typically more than 100 pages long, protocols spare no detail in outlining the goals of a clinical trial, the background of the disease being studied, criteria for including and excluding patients, safety monitoring and more.
Protocol Coordinators also develop study documents like patient consent forms. They anticipate issues and guide problem-solving, keeping everyone and everything on the same page. To keep things moving forward smoothly and on schedule, Protocol Coordinators must have an exacting grasp of the big picture, the finest of details, and how each detail is interconnected with so many others.
“Even a single modification to the protocol can trigger a cascade of changes that impact various elements of the study,” said Senior Protocol Coordinator Lee Baker, MPH.
If a change needs to be made to a protocol — like the number or timing of sample collections or the volume of a sample — that change needs to be made 100 times over throughout various clinical trial documents. This is especially important in informed consent documents, so patients and families can fully understand what will happen during the study before they agree to participate.

Once a trial is up and running, Protocol Coordinators typically step back, leaning in only if there’s something mission-critical to update in the protocol. 

Research Coordinators: Collecting and Managing Incoming Data

This is when Research Coordinators step in. Their first job is a big one: to create all the forms and tools hospitals use to collect and submit their data. 

They work closely with Statisticians, setting up systems for enrolling patients, assigning treatments, and randomizing — dividing patients into similar groups so researchers can fairly compare different treatments and learn which one works better.

“We have to make sure we’re capturing data in a way that we can actually understand what we learn once a trial is up and running,” said Lynn Shen, MPH, a Data Operations Specialist and Director of Research Teams. ​“Large-scale, complex randomized control trials might have 40 different forms for gathering data,” Lynn said, “while simpler trials would have half that many.”

Clinical research associates (CRAs), who work for the hospitals, universities, and cancer centers that participate in trials, enter all the data gathered from patients and contact COG research coordinators if they run into any issues along the way.

It’s no small task to keep everything related to data collection moving forward and aligned with the timeline for a trial, but data operations specialists thrive on tricky challenges.
“You never get bored working at COG,” Lynn said. “There’s always something going on with the sites or committees or both, and it’s a great sense of accomplishment to help come up with the right solutions.”
Coordinators in Action

Lee Baker specializes in early-phase trials of new drugs for childhood cancer. At any given time, he coordinates 10 to 15 clinical trials — some of them concepts or proposals in development, others active studies.

One trial he’s worked on recently is studying a new drug that makes cells more susceptible to radiation therapy. Researchers hope it will improve outcomes for children with three types of glioma, all aggressive brain cancers that are largely unresponsive to chemotherapy and radiation.

“It’s exciting to see early-phase trials and new therapies, new treatment options, new medications, different approaches being put into place in a very practical way,” he said. “It’s sort of like seeing where the cutting edge is in real time.”

Rachel M. Vasquez, MS, a Senior Protocol Coordinator and Senior Scientific Writer at COG, works exclusively on the ALL (Acute Lymphoblastic Leukemia) trials.

“I’ve been really fortunate in the six years I’ve been at COG to see two very significant breakthroughs in pediatric leukemia research come to fruition,” she said.
Both trials involved an immunotherapy drug called blinatumomab, which worked so well, the clinical trial closed early opens in a new tab so they could get it to as many children with B-ALL as possible.

Now Rachel is working with researchers on a trial that will build on that breakthrough by optimizing the use of immunotherapy and zeroing in on the lowest effective dose of chemotherapy for B-ALL patients.

Melina Chanthanouvong focuses on cancers of the central nervous system (CNS) and is coordinating one study looking into lowering radiation doses for patients with a rare germ cell tumor that develops in the brain or spinal cord. The goal of the study is to reduce long-term side effects on memory, language, reasoning, and other cognitive functions that radiation can harm.

“The most fulfilling and fascinating thing is being able to just continue pushing the envelope a little bit further each time that we find new information and build new studies,” she said. “Every time we push that envelope, we learn a little bit more about our society, about cells. It’s exciting to be a part of it.”

All this behind-the-scenes coordination helps researchers develop and run clinical trials as efficiently and effectively as possible. This is how researchers keep science moving forward, building on one discovery at a time toward COG’s vision: a future where no child or adolescent dies of cancer and survivors live healthy, fulfilling lives.