NCI Announces Funding for Development of Standardized Electronic Treatment Plans for NCI-Supported Clinical Trials Applicable across Clinical Research Sites

Electronic Health Records (EHR) and Treatment Plans Are Essential to Cancer Clinical Trials

All NCI-supported Cancer Centers utilize 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 for all in- and outpatients treated at these sites, but they are also critical components of sites’ financial infrastructure.

Electronic Treatment Plans Involving Investigational Agents for Clinical Trials Are Complex

Multisite studies, like those performed by NCI’s clinical trials networks, currently require repetitive efforts to modify EHR systems across potentially hundreds of institutions. This process has contributed to both prolonging the activation times and increasing the cost of NCI-supported clinical trials.

• Each electronic treatment plan must be built individually, regardless of the patient population (e.g., rare tumors vs common malignancies).
• Essential ancillary procedures that change from study to study and site to site must be programmed into the treatment plan.
• Treatment plans must be tailored to produce clinical charges that reflect only those permitted by either governmental or commercial insurers; the more study arms (such as in a basket trial), the more costly the treatment plan builds become.

NCI Administrative Supplements Are Providing Pilot Study Support to Two Consortia of Clinical Trial Sites

Study Goals

• Consortia institutions will meet regularly with the NCI to develop processes across multiple NCI-supported Cancer Centers and community sites that will facilitate the development of single EHR clinical trial treatment plans that can be deployed at multiple institutions in support of NCI-sponsored network studies.
• These projects will determine whether two consortia of clinical trials sites that have substantive histories of patient accrual to NCI trials, collaborating with an established EHR vendor and the NCI, can 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 trial build system.

Institutions Comprising the Two Funded Consortia of Clinical Trial Sites