CCSG supplement: Creating an efficient clinical trial build system via the Clinical Trials Rapid Activation Consortium (CTRAC)

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PROJECT SUMMARY Standard-of-care electronic health records (EHR) treatment plans are constructed once prior to implementation and support quality through standardization. By comparison, treatment-plan builds for clinical trials may support as few as zero trial participants, must be built from the ground up for each new trial and at each added site, and have treatment plans that often require configurations for novel medications, numerous ancillary procedures, and research finance requirements. The current paradigm is costly, complex, and inefficient. Representatives of five cancer centers agreed to be part of the project’s Clinical Trials Rapid Activation Consortium (CTRAC). The project’s goal is to develop processes across multiple NCI-supported cancer centers that will facilitate the development of single builds of EHR clinical-trial treatment plans that can be deployed at multiple institutions in support of NCI- sponsored network studies. Members will investigate the question: can a small consortium of clinical trials sites develop methods to standardize workflows, drug formularies, drug administration procedures, and laboratory requirements leading to the creation of the components for a standardized, electronic, clinical- trials build system? Specific aims are as follows: 1) To identify the tasks currently performed by EHR investigational treatment plans (SOPs, policies, and workflows) and to define differences among these SOPs at the individual member sites of the consortium; 2) To standardize the processes within each task where possible and document differences that would require modifications across sites; 3) To develop a master assessment of EHR treatment-plan modules that could be reused to perform components of the same research protocol tasks at multiple sites while maintaining compliance with the requirements of member organizations of the consortium; 4) To organize a leadership structure for the consortium that will work with the NCI and an EHR provider to oversee this initiative to assure that adequate progress is made toward the ultimate goal of creating a fully automated electronic clinical-trial build system that will facilitate the activation of clinical trials across all NCI- supported networks; 5) To build standardized electronic clinical-trial build modules that could undergo future pilot testing at each institution for a specified group of NCI-sponsored clinical trials; and 6) To facilitate development of metrics for the new EHR processes that can demonstrate whether more consistent patient care, reduced medication errors, and fewer adverse events result from a standardized approach to clinical-trial build modules.