Building Capacity for the Clinical Trials Office at Children's Hospital of Wisconsin - Strengthening Phase I & II Trials Infrastructure
Background: There is an urgent need for improved and safer therapies for the treatment of children, adolescents and young adults (AYA) diagnosed with high-risk, pediatric cancers. Testing of new therapies for pediatric cancers requires an experienced network of clinical scientists, research nurses, investigational pharmacists, regulatory experts and data coordinators in order to manage early-phase clinical trials. Project Goal: To help meet the growing needs of the Pediatric Cancer Developmental Therapeutics (DVL) Program at Children's Hospital of Wisconsin, we are requesting funding for a Research Nurse to help organize, educate and oversee care of patients enrolled on early phase clinical trials. In addition, support for the dedicated time of an Investigational Pharmacist will ensure standardization and regulatory compliance with increasingly complex clinical trial requirements. Investment by Alex's Lemonade Stand Foundation (ALSF) will provide the necessary resources required to support investigator-initiated trials that are critical to increasing clinical trial opportunities to children, adolescents and young adults diagnosed with pediatric cancer in Wisconsin and throughout the upper Midwest.
Update: July 2016
In Year 1 of this award, 13 new early phase trials were opened at our center (consortium, investigator-initiated) and we have collaborated with outside centers in an effort to increase accrual on two of our investigator-initiated trials. Enrollment on early phase clinical trials at our center has remained consistent, with 25 patient enrollments over the last year. Of these enrollments, eight were adolescents and young adult patients.
In Year 2 and beyond, our specific aims are to continue to increase the size & scope of our early-phase clinical trials operation. As the world of cellular therapies continues to expand, there is an increased emphasis on the development of immunotherapies for the treatment of cancer patients who have failed conventional therapies. With the recent reorganization of our DVL program and addition of a distinguished researcher in cellular therapy at our institution, our early-phase clinical trials program is positioned to increase the number of immunotherapy trials available to the pediatric and AYA cancer patients in the coming years.