Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program.

The Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As such, there is potential for a networked and centralized study approach to address these barriers. Here we discuss adapting a just-in-time clinical trial approach for adults to serve the pediatric oncology population. Through innovative patient matching solutions leveraging large, real-world datasets with high computational power, the Tempus Integrated Molecular Evaluation (TIME) for Kids Program aims to address barriers in the development of new therapies. This commentary explores the potential for reducing challenges in developing novel pediatric therapeutics, advancing equity in genomic biomarker testing for precision tailored treatment, and improving outcomes for pediatric oncology patients.

Invasive Fungal Infections While on Voriconazole, Liposomal Amphotericin B, or Micafungin for Antifungal Prophylaxis in Pediatric Stem Cell Transplant Patients.

OBJECTIVE: This study aimed to report the incidence of invasive fungal infections (IFIs) in pediatric hematopoietic stem cell transplant (HSCT) patients who received voriconazole, liposomal amphotericin B (L-AMB), or micafungin for primary antifungal prophylaxis (PAP). METHODS: Using data retrospectively collected from institution's electronic records, this study analyzed the incidence of IFIs in pediatric HSCT patients between November 2012 and November 2016. RESULTS: A total of 103 patients were screened. Of the 84 patients who met inclusion criteria, 76.2%, 29.8%, and 19% patients received voriconazole, L-AMB, and micafungin, respectively. The incidence of overall IFIs was 2.08 per 1000 prophylaxis days. There were 2 mold infections identified in 2 patients. Among 3 antifungal agents, the rates of IFIs were 2.67 per 1000 prophylaxis days in L-AMB group, 2.08 per 1000 prophylaxis days in micafungin group, and 1.17 per 1000 prophylaxis days in voriconazole group. CONCLUSION: Patients who received L-AMB or micafungin had higher rates of IFIs than those who received voriconazole for PAP.

Preoperative Antibiotic Orders: Protocol-Initiated Pharmacist Order Entry.

OBJECTIVE: To evaluate the antibiotic selection of preoperative orders before and after a pharmacist order entry protocol for patients with methicillin-resistant Staphylococcus aureus (MRSA) colonization. METHODS: A retrospective chart review of orthopedic surgery procedures on patients with MRSA colonization at a free-standing, academic pediatric hospital, between February 2010 and February 2012. RESULTS: Procedures that were performed pre protocol (n = 27) implementation had a 63% rate of appropriate antibiotic selection compared to 81% in the postprotocol group (n = 32; p = 0.1155). The preprotocol group dose accuracy was 96% compared to 97% in the postprotocol group (p = 0.81). Two procedures, 1 in each group, were redosed appropriately for extended surgery duration. Correct timing of antibiotic administration occurred in 82% of cases pre protocol versus 68% post protocol (p = 0.42). CONCLUSIONS: Patients with MRSA colonization had a greater rate of appropriate drug selection after the implementation of a pharmacist-initiated preoperative protocol. Correct antibiotic dose and redose remained consistent between the study groups. Most of the orthopedic procedures performed included patients on antibiotic coverage at steady state for ongoing infections, which impacted the analysis of preoperative timing. Further studies should be conducted to assess whether the increase in the number of appropriate antibiotic selections decreases the rate of postoperative MRSA infections.