A key barrier to overcome in delivering novel therapeutics to the pediatric patient population is the complexity of initiating multi-site pediatric trials under investigator-held INDs that are dependent on cGMP cell production facilities.
To address these complexities, the CPCI has established an Immunotherapy Consortium Coordinating Center which brings together expertise in clinical trials management, regulatory affairs, pharmacovigilance and biostatistics and data management to more efficiently launch trials. In addition to serving as a resource for those in the Consortium launching multi-site trials, we have developed numerous tools including SOPs, protocol templates and a CRM for patient/manufacturing scheduling.
Further, we have enhanced our project management commitment to more efficiently orchestrate the many resources and activities required for successful opening and ongoing management of these trials.
When launching multi-site trials, the Consortium is leveraging the single IRB framework to streamline the IRB review process.
The Consortium brings together those with significant clinical and safety expertise, as well. We are providing training for clinical research staff, lab technicians and MD’s to ensure the safe conduct of early stage trials. In addition, we have established a Data Safety Committee to ensure standardized grading and reporting of adverse events.
Further, trial design has been improved by the biostatistics and data management group to meet the inherent challenges of rare-disease-focused clinical trials enabling standardized statistical analysis plans, a single electronic data capture system and a global case report form library are in progress and will improve data quality and reporting efficiency.
