Background (see attached)
All NCI-supported Cancer Centers utilize electronic health records (EHRs) to support the delivery of standard-of-care and investigational diagnostic and treatment programs. These health record systems not only provide a standardized approach to the care plans used for all patients (both inpatients and outpatients) treated at these sites, but are also critical components of the financial infrastructure used to recover clinical charges from third party payers for services rendered. While the EHR-based care plans for routine therapies provide quality control through the standardization of care processes, such as the administration of pharmaceuticals (chemo- and immunotherapy, for example), these procedures may vary considerably from one health care provider to another, even when the same EHR is in place at both organizations. To support clinical trials that employ investigational agents, furthermore, each electronic treatment plan must be built from scratch, whether or not the trial targets a patient population suffering from a rare tumor (which might have very low accrual) or a common malignancy. The complexities surrounding development of treatment plans that utilize non-FDA approved therapeutics also require the programming into treatment plans of essential ancillary procedures that change from study to study, and site to site; they must also be tailored to produce clinical charges that reflect only those permitted by either governmental or commercial insurers. The more arms incorporated into the study (as would occur in a basket trial), the more costly the treatment plan builds become. Multisite studies, like those performed by NCI’s clinical trials networks, thus require repetitive efforts to modify different instances of EHR systems present across potentially hundreds of institutions. It is clear that this process has contributed to prolonging the activation times as well as increasing the cost of conducting NCI-supported clinical trials.