The training module developed by Johns Hopkins All Children’s experts entitled “Operationalizing Good Clinical Practice (GCP) in Pediatric Clinical Research” aims to enhance the use of best practices throughout the life-cycle of pediatric research studies.

Several times each year, clinical trial experts at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida, conduct an in-person training session for researchers at the hospital who study new medications or medical devices in clinical trials focused on children. These sessions go beyond the conventional approach of teaching research regulations, policies and principles that are designed to assure clinical trial integrity and quality; they also focus on how to translate these principles into best practices in a pediatric setting.

Now, in collaboration with Johns Hopkins Medicine research leaders in Baltimore, clinical trial experts at Johns Hopkins All Children’s have developed the in-person training into an easily comprehensible computer-based training module, certified through TransCelerate (a pharmaceutical industry collaborative).

According to Megan Singleton, J.D., M.B.E., C.I.P., Johns Hopkins Medicine assistant dean for Human Research Protection, “This Johns Hopkins All Children’s-developed training resource for best practices in pediatric clinical trials is a valuable addition to the Human Research Protection Program at Johns Hopkins Medicine, and provides an excellent example of the synergy taking place among the St. Petersburg and Baltimore campuses. We’re excited to make it available to pediatric researchers throughout Hopkins.”

The training module is entitled “Operationalizing Good Clinical Practice (GCP) in Pediatric Clinical Research.”

Heather Cronin, M.Sc., manager of the Research Regulatory Affairs and Quality Assurance Unit of the Johns Hopkins All Children’s Clinical and Translational Research Organization, and lead author of the training module, explains, “GCP is a set of international standards for best practices in clinical trials. We believe our investigators and research staff come out of the training understanding not only GCP, but also how to operationalize GCP in their daily activities running clinical trials. Throughout the training, we promote the development and utilization of standardized procedures and checklists at each institution that engages in clinical research, in order to foster adherence to best practices.”

Frances Hamblin, MSHS, R.N., CCRP, director of research operations in the Clinical and Translational Research Organization, who collaborated closely with Cronin in developing the training module, adds, “By using these standardized procedures and checklists in daily activities, we can best assure that clinical trials are being conducted with the highest level of quality and integrity.”

Through their involvement in the Best Practices Committee of the non-profit Institute for Advanced of Clinical Trials for Children (I-ACT for Children), Johns Hopkins All Children’s pediatric clinical trial leaders are also making the training available to other institutions and organizations through North America.

Neil Goldenberg, MD, Ph.D., Johns Hopkins All Children’s director of research, chief research officer of the All Children’s Research Institute, and professor of pediatrics and medicine at the Johns Hopkins University School of Medicine, remarks: “The TransCelerate goal to continually improve the efficiency and quality of clinical trials resonates greatly with us here at Johns Hopkins All Children’s, and has been a key focus of our efforts over the past six years since the founding of the Johns Hopkins All Children’s Clinical and Translational Research Organization. When we recently developed this new pediatric-focused GCP training module, with its practical approaches to applying research principles in real-world pediatric clinical trial settings, we also saw I-ACT for Children as a key partner and platform for disseminating the unique module to pediatric researchers worldwide.”

Lisa Benson, B.S., CCRP, CRCP, I-ACT for Children senior vice president for research, quality and education, notes, “This effort strongly aligns with the work I-ACT for Children is doing with collaborators at Duke University in the area of pediatric GCP training. The Johns Hopkins All Children’s team has created an outstanding pediatric GCP training program, with excellent content and flow that is easily comprehensible; our plan is to integrate a number of its components into our site network training.”

Goldenberg puts this accomplishment into broader context, emphasizing, “It takes a very special child and parent to participate in a pediatric clinical trial; yet, so many do participate, largely motivated by the desire to improve treatments for future children.”

He adds, “As pediatric investigators and research leaders, we are inspired to conduct clinical trials because of this same desire to improve children’s health. However, our passion for how we conduct pediatric clinical trials needs to match our passion for why we conduct them.”