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Building the Culture of Hope: Pediatric Cancer Clinical Trials


Childhood cancers are different from adult cancers in development, treatment, tolerance of therapy and prognosis. Pediatric cancer experts from the MCW Cancer Center and staff from Children’s Hospital of Wisconsin (CHW) are dedicated to research, early diagnosis, and treatment of children's cancer.  They are also critical in helping children and their families through the process.  As the only hospital in the state designated as a Phase I Center by Children's Oncology Group (COG), one of only 21 nationwide, children treated at CHW have access to additional clinical research trials that explore new therapies for childhood cancer.

A key difference in pediatric cancer is the rate at which patients are enrolled in trials, and the attitudes of referring and treating physicians, patients and families. For children with cancer, clinical research studies are considered the standard of care. 

CHW sees more than 150 newly diagnosed patients each year and actively manages more than 600.  Of these hundreds of pediatric cancer patients, the majority are enrolled in at least one clinical trial, and it is common for patients to participate in multiple trials.  Based on COG data from 2012, CHW is now ranked #10 in enrollment totals, up from #14 in 2011. 

An enormous amount of work is required to manage that number of trials and accruals, and that is the responsibility of the pediatric Clinical Trials Office (CTO).  Under the direction of Michael Kelly, MD, PhD, and led by Jennifer Brown, Clinical Research Manager, the pediatric CTO is a centralized hub, providing specialized support in trial coordination, processes and procedures, regulatory requirements, monitoring, and documentation and tracking.  This allows pediatric cancer investigators to focus on the patient, the science, and on initiating more trials.  

The pediatric CTO works closely with their counterparts on the adult side, sharing data, processes and information.  The goal is seamless integration and centralization of all cancer clinical trials across the institution.  

Jen Brown and her team are proud of their role in this culture of hope. The team has a clear understanding the role they play in helping patients, families, investigators and the science of cancer research.  

Meet the Pediatric CTO Team

Learn more about the team, and how they help cancer investigators and clinicians conduct better trials, conduct more trials, and help more kids.  


Jen Brown, Clinical Research Manager

Three words that describe Jen:

  1. Helpful
  2. Knowledgeable
  3. Dedicated

Why She’s Important:  “Intricate regulatory requirements, complex protocols and processes are simply the reality of clinical trials, particularly early phase trials.  We are really good at managing those regulations, complexities and processes so our researchers are freed up find new and better treatments.  Our knowledge and expertise leverages our docs and investigators so more kids can enroll in more trials with more effective treatments.”

Why She’s Here:

“Clinical trials provide hope to kids and families devastated by this disease. What could be a better reason for getting up in the morning? It also helps having such an amazing CTO team and a wonderful group of doctors and investigators.”


Pam Boettcher, Regulatory Specialist

Three words that describe Pam

  1. Consistent
  2. Diligent
  3. Prepared

Why She’s Important

“I maintain audit readiness at all times. I built systems so only the most current, approved documents are available, and all of the forms look consistent.  This gives the team confidence – they know they have access to the right document at any time.”

Why She’s Here

“Docs should be treating kids; they need to focus on that.  Docs are here for a reason, and I’m here for a reason, and that means the docs have one less thing to worry about. “


Katy Murphy and Cheryl Petersen, Research RNs

Three words that describe Katy and Cheryl 

  1. Teachers
  2. Guides
  3. Translators

Why They're Important

Katy: “I help educate children and their families about trials and treatments during one of the scariest times of their lives.  I help patients and families understand what to expect at a time when it is difficult for them to listen or comprehend.”

Why They're Here

Katy:  “This is a terrible disease and the treatments are often also terrible.  We must do better.  We must find better ways for these children and their families. That’s why I’m here."

 

 

 

 

 

 

 

 

 


 
Clinical Research Coordinators 

Developmental Therapeutics

Kristine Allmendinger-Goertz, BMT/DVL, IND

Megan DeMara-Hoth, DVL

Sonya Carpenter, BMT, DVL

COG Phase II / Phase III Clinical Trials

Malini Shankar, COG Lead

Chris Hanson, Solid Tumors

Carly Casper, Solid Tumors

Michelle Martin, Leukemia

Becky Rehborg, Leukemia and COG Phase 1

Mary Kirby, Patient Triage, Specimen Shipping
 
Non-Therapeutic Trials

Eva Igler

CIBMTR Data Reporting

Christine Lange

Three Words that describe Clinical Research Coordinators:

  1. Architects
  2. Facilitators 
  3. Detectives

Why They’re ImportantQuotes from the Team:

“These protocols start with us, we’re the bridge to the other team members.  We get things started, but we also are the “go-to” throughout the trial - we get questions about the protocol from pretty much everyone involved, for the entire length of the trial, and beyond.  Not just  doctors and nurse practitioners, but many others – pathology, radiology, neuropsychology, the labs, pharmacy. 

Each protocol is totally unique, incredibly complex.  The consent packet alone can be 50+ pages long.  It’s somewhat overwhelming to someone who is somewhat familiar with the process, and absolutely overwhelming to a patient and parent who just received a cancer diagnosis." 

"The process to be on a trial is also totally overwhelming – the scheduling, organizing, tests, labs, drugs, treatments, side-effects.  It’s mind-boggling.  Each day’s order for a single protocol can have 25 individual steps involved, including sending labs across the country to Seattle for COG trials. 

"This is why the role (CRC) is so important.  If someone wasn’t here managing all of these complex steps and processes, there would be so many fewer trails.  The investigators don’t have time to do all this, and it takes a lot of specialized knowledge, single-minded focus and a multi-disciplined background to really do well at this job."

"The investigator-initiated trials are probably the most challenging thing we do.  These require a greater level of collaboration with different specialty areas, and the protocols and processes are generally just more complex.  These are the trials that really stretch us as coordinators and push us to do our best."

"We’d like people to understand that being a CRC is a profession – we have professional societies, we can become certified, there are degree programs for CRCs.  It’s an important job."

"Participation in Children’s Oncology Group (COG) trials require many lab and specimen shipments, usually on a daily basis.  Without Mary, our investigators couldn’t share critical data with other COG sites around the country, and the world."

Why They’re Here:

Chris:  “I love the unexpectedness of my job, and although challenging, there are issues we have to address that go beyond anything that I could have predicted.  For instance, when we are consenting children who are about to start puberty, we need to talk to about how treatments impact fertility, pregnancy, and the importance of sexual abstinence or birth control while on trial. This can be a very sensitive thing to discuss with parents and sick kids, but they need to know.  It takes a lot of tact and knowledge to understand the best way to have that sensitive conversation.”

Carly: “Even though I’ve only been here a short period of time, I love the team I’m working with and I’m happy to have the opportunity to work at such a prestigious institution.  I really like all of the different types of people I work with.”

Michelle:  “I have a background in law, social work and library sciences, and this is the first job where I can use skills and experience from all three of these areas. It’s amazing to know that our work helps develop new treatments.  Or, for example, in the case of some of our hi-risk ALL studies, we provided the data that made the case to stop a type of treatment because of dangerous side effects. 

Becky: “Being a CRC gives a new meaning to the word multi-tasking.  We are constantly juggling different protocols, tasks and priorities, and some of my contacts are some of the most influential people in the organization.  You can’t be afraid to ask questions, point out issues and be assertive.  We helping to create a new standard of care, we’re not just satisfied with the status quo, and are always seeking something better than what is available now.”

Mary: "None of us work individually, we work as a team.  Even if it's just validation, bouncing ideas off of each other. We all work great together."

 

 

 

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Page Updated 04/09/2014