Some data necessary for trials is in the EHR, but not expressed in a standard, structured way (e.g., they are in Notes).
Any data necessary for trials and already in the EHR must be manually re-entered into case report forms (CRFs).
Investigators leverage clinical treatment data captured in the EHR to derive and/or compute clinical trial endpoints.
Eliminates (or at least reduces) the need for manual entry of duplicate data into case report forms (CRFs).
If the trial requires data stored outside the EHR (e.g., patient-reported outcomes, laboratory data, etc.), ideally this data can also be expressed in a standard, computable manner via mCODE and extensions.
Obtain and/or derive clinical trial endpoints from EHR data rather than by traditional clinical trial data collection methods (i.e., by manually entering data into separate case report forms).
Investigators and/or trial sponsors want to conduct a clinical trial for a new oncology treatment.
Protocol and required consents are established.
Researchers have identified mCODE data elements and extensions that are required for analysis and computation of trial endpoints.
These mCODE data elements and extensions are available in the EHR or in other accessible systems.
Streamlined, less costly, more inclusive clinical research overall as a result of:
Lower burden on participating sites by reducing or eliminating the need for manual entry of duplicate data into case report forms (CRFs).
Opportunities to include a greater number of patients in clinical research by leveraging data generated in their regular course of treatment.
Researchers identify mCODE data elements and extensions that are required for analysis and computation of trial endpoints.
Providers capture treatment data during the regular course of care for patients.
This will require low-burden methods to capture high-quality data at the point of care.
Required mCODE and extension data are extracted from EHR and transmitted to clinical trial data management system.
See Alternate Path 3A on following row.
Investigators perform their clinical trial analysis.
3A. Sites may store required data elements in non-EHR systems; ideally, these data can be expressed as mCODE/extensions regardless of where they are housed. However, the need to extract and share data from disparate sources may add complexity to the process.
Definition of scope will need to consider that data available in EHR vs. other systems will vary from site to site.
ICAREdata Study is testing the feasibility of this concept in phases. To support ICAREdata, an FHIR Implementation Guide was developed that adds cancer disease status and cancer treatment plan change to the base mCODE data elements.
Extending mCODE with additional data elements beyond disease status and treatment change could prepare us to broaden clinical research applications:
Elements commonly used across CRFs
Elements specific to a type of disease or trial in development