When is an MDR not an MDR?
There’s a standard for that! ISO 11179 is the standard for metadata registries and is something you should look out for when selecting a Metadata Repository (MDR) solution. Take a look at Frederik Malfait’s post on the importance of ISO 11179. An enterprise grade MDR will utilize an ISO 11179 metamodel to provide the capability to manage standards. The primary use case for an MDR within Clinical Development is managing the CDISC standards. It’s important to highlight that the ISO 11179 metamodel can extend beyond the CDISC use case to manage and control many other clinical development standards, including the OMOP CDM for real world data specifications, or FHIR profiles.
The Business case for CDISC standards, produced by CDISC, Gartner, et al, (updated in 2014), highlighted that up to 80% of efficiency savings are gained through implementing standards at the Study Start-up Stage. In order to realize that level of savings, an effective MDR will have to manage standards through the full clinical development lifecycle. It will provide integration capabilities to feed metadata directly into business processes so that it is easily consumed by both systems and people, breaking down silos within the clinical development organization. When you layer configurable governance workflows on top of all this, and you will have an MDR that provides the foundation for deep process automation.
We cannot overstress the importance of having the full Clinical Development Organization (CDO) involved and engaged in an MDR project. Executive level sponsorship is equally important to provide enterprise-wide buy in. A successful MDR project relies on both high-level and grass roots support to provide a robust solution and a foundation on which to build impactful automation solutions.
Most of us wouldn’t consider buying a car without test driving it first, and ensuring the specifications meet the requirements. For example a two-seater sports car would not be a practical choice for a small family. The same considerations should go into selecting your MDR solution; take it for a spin to see how well it handles your requirements and plans for driving future growth and efficiency. You will need to define a set of use cases that encompass broader CDO needs and run a Proof of Concept (POC) with your vendor shortlist. The ideal POC brings your data into the demonstrated use cases to make it more meaningful and translatable. Don’t be afraid to rethink existing processes to position your MDR for greatest impact.
It’s never too soon to start thinking about standardization. It’s also never too late. It is important to not limit your thinking. When you have fully connected metadata it is well within the realm of possibility to deliver a push button study design solution. I would argue that you must have a high degree of automation in order to keep up with the complexities of clinical development.