Testing the safety and efficacy of drugs designed for pediatric patients has always been challenging, largely because pediatric patients are not just “little adults” and the findings of clinical research in adults cannot be generalized — or extrapolated — to infants, children and adolescents.

As a result, a research design for pediatric clinical trials requires developing appropriate outcome measures for children of different ages, determining proper dosages for their developing bodies, and providing pediatric-appropriate trial settings as well as research personnel familiar with — and responsive to — a child’s physical, cognitive and emotional development.

Clinical research coordinators play a valuable role.

Essential for conducting clinical trials for pediatric patients are the clinical trial coordinators who interface with clinicians, principal investigators, nurses, the children participating in the clinical trials, and their families.

Anna Eidenberger, B.S., M.S., is a Johns Hopkins All Children’s Hospital pediatric advanced clinical research coordinator in St. Petersburg, Florida, whose busy days are filled with important responsibilities.

Her daily tasks include screening pediatric patients for eligibility for clinical trials, conducting “informed consent” discussions with parents to have their child in a clinical trial (and with the pediatric patients, in an age-appropriate fashion), enrolling patients, planning and tracking research visits, coordinating various diagnostic tests specified by a research protocol (such as echocardiograms, or blood work), administering questionnaires, and collecting patient blood samples, urine or saliva for research testing.

She is also involved in collecting study data, performing data entry into secure research databases, monitoring for and tracking any notable events that a patient may experience while participating in a research study, as well as attending meetings with the principal investigator and others on the study team.

Eidenberger, who has a bachelor’s and master’s degree in psychology from Florida State University and Arizona State University, worked in adult clinical research for several years before coming to Johns Hopkins All Children’s to work as a pediatric clinical research coordinator.

“I wanted to work at a well-established research institution,” Eidenberger recalls. “I was looking for a place where I could learn and grow — and that is why I came to Johns Hopkins All Children’s. I knew I would like it, but I was not expecting to love it as much as I do.”

What does she love about being a pediatric clinical research coordinator?

“I love everything about being a clinical trial coordinator!” she explains enthusiastically. “Research is such a robust experience — start to finish. The coordinator role allows me the opportunity to understand all aspects of the research process from study start-up to protocol execution, to study termination, and seeing where the collected information is taken and how it is used.”

Her responsibilities are not all administrative.

“When you work with the family of a child who has been enrolled in a pediatric clinical trial, it is a case-by-case activity,” she explains. “Working with families is delicate — they may be frightened at first about having their child enrolled in a clinical trial, and I am not there to impose anything on them, but to provide them with important information and also remind them that participation is voluntary so that they may make a fully informed decision and feel respected by this institution.”

Becoming a Mentor

Because of her expertise in coordinating pediatric clinical trials, Eidenberger was recently chosen to have training as, and function in a role of, an external mentor for clinical research coordinators at other institutions, through the Institute for Advanced Clinical Trials for Children (I-ACT), a national organization with which Johns Hopkins All Children’s has been an affiliated I-ACT member since 2018.

I-ACT’s mission is to engage clinical trial site personnel in continuing educational opportunities to ensure that health care for children is continually improved by the organization’s efforts to enhance the awareness, quality and support for pediatric clinical trials. The organization also works to support and expand the next generation of pediatric clinical research staff.

“Johns Hopkins All Children’s and I-ACT share a passion for enhancing the quantity and quality of clinical trials across the pediatric health spectrum and to fulfill a critical need for providing greater evidence on safety and efficacy of medications, medical devices and biological therapeutics in children,” says Neil Goldenberg, M.D., Ph.D., associate dean for research and director of the Johns Hopkins All Children's Institute for Clinical and Translational Research. “By working together, we and other I-ACT network sites, along with pediatric leaders from the pharmaceutical industry and the U.S. Food and Drug Administration (FDA), can achieve our common goal of accelerating the availability of ever-better disease treatment and prevention options for children.”

In January, Eidenberger was selected to attend an I-ACT two-day mentoring orientation where she learned tips, procedures and “best practices” to help enhance her skills as a mentor to clinical research coordinators at other institutions as well as Johns Hopkins All Children’s.

Through I-ACT, clinical research coordinator mentors such as Eidenberger foster personal growth, professional development and enhancement of the technical skillset of their mentees, and help them identify opportunities for networking and collaboration.

“The I-ACT orientation was a great experience. The program’s structure is very developed and the leadership team is very helpful,” Eidenberger says.

Her selection as an I-ACT mentor is as important to her as it is important to the leaders at Johns Hopkins All Children’s who will call on her to mentor clinical research coordinators internally as well, and to help inform and guide the continued growth of mentorship and professional development for clinical research coordinators across the Johns Hopkins All Children’s campus. “Anna is a great mentor,” says Jade Hanson, M.S.N., R.N., director of Clinical Research Operations at the hospital. “She provides guidance, support and wisdom to help others reach their full potential, offering encouragement, knowledge and advice.”

Hanson also recognizes Eidenberger’s administrative skills and work ethic.

“She consistently sets goals, works hard, and perseveres through challenges and pushes herself beyond her comfort zone to stay committed to her professional and personal aspirations,” Hanson adds. “I've enjoyed mentoring Anna and watching her grow, sharing knowledge, and building a meaningful connection.”

The Center for Pediatric Clinical Translational Research Training, Education, Engagement and Mentorship in the Johns Hopkins All Children’s Institute for Clinical and Translational Research serves an education and training resource to the hospital’s principal investigators, sub-investigators and their study team members on best practices for conducting clinical research. Directed by John Morrison, M.D., Ph.D., the Center aims to increase clinician engagement by providing a detailed understanding of the process for opening a protocol and conducting research at Johns Hopkins All Children’s. “Anna is a tremendous asset to our organization and our research efforts,” Morrison explains. “She has a unique combination of knowledge, skill, and tenacity that allows her to make an immediate and lasting impact on clinical trials and other clinical research studies conducted here and I admire her passion for expanding her expertise and am both proud of and excited for her to embark on this journey as a mentor to others. We are grateful she was chosen to share her talents as we carry out research aimed at discovering and delivering innovative health care.”

Life Beyond Work

Eidenberger, always the eager learner, even when not involved in the fast-paced, daily “ins and outs” of conducting clinical trials, loves to learn by traveling internationally. Her destinations have included Mexico, Spain, France, Italy, Jamaica, Ireland, Puerto Rico and more. Her favorite explorations have been Iceland, Colombia, Indonesia, Portugal and Russia. She plans to see Brazil next.

“When I travel, I like to connect with the locals in their daily settings so I can learn about their culture and what is important to them.”

Eidenberger’s ability to connect with people from all walks of life, and of all ages, is a tremendous asset for her role as a clinical research coordinator, and a quality that is shared by many of her pediatric colleagues throughout Johns Hopkins All Children’s.