Thursday, September 18, 2014

Two New RBM Papers from TransCelerate

From One, Come Two
If you follow the TransCelerate RBM initiative closely, since its July update you’ve been eagerly anticipating the availability of the paper entitled “TransCelerate BioPharma: Central Monitoring Model and Technology Specification Proposals to Enable Risk-Based Monitoring Adoption.”  Now that the paper is publically available, your patience has been rewarded twice.  TransCelerate chose to divide the single document into two, one focusing on central monitoring, the other focusing on RBM-enabling technologies.  Publishing separate documents was a good decision.  As you’ll see, each topic is certainly rich enough to warrant individual treatment.

“Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach Part I.”
This paper describes central monitoring as just one component of an overall RBM strategy that includes on-site and other off-site monitoring activities, as well.  Central monitoring identifies study risk indicators that undergo a data analytics process, the results of which are monitored via visualization software.  Its goal is to “ascertain when to act or conduct an intervention based on outliers and trends,” which distinguishes it from other types of central data review, such as safety monitoring, data management review, medical review, or statistical review.  Any central monitoring strategy incorporates people, processes, and technology, and will likely be implemented very differently across companies.  The paper provides 4 different flowcharts representing 4 different examples of central monitoring implementations that differ in the way people, processes, and technology are organized and interact with each other.  As the title of the paper foreshadows, TransCelerate plans to publish a follow-up paper that will report on member companies’ use and application of risk indicators, and experience with different RBM implementations.

An observation: As a company defines and adopts its own RBM approach, we can expect its org charts, position descriptions, and SOPs to document the specifics of its person/process/technology triad.  It’s worth noting that contractors, consultants, vendors, and other service providers who operate across sponsor companies will be quite challenged to first figure out, then effectively navigate and communicate within the different RBM implementations they encounter.

“Technology Considerations to Enable the Risk-based Monitoring Methodology”
TransCelerate looked at existing computing systems and performed a gap analysis to develop a set of desirable capabilities for RBM technology.  If you’re an RBM webinar (RBM-inar?) devotee like some of us, you’ve seen demos, or at least screen shots, of some of the slicker RBM dashboards out there.  (If you haven’t, go sign up for one, so you can visualize the direction that monitoring is taking.)  The webinars typically demonstrate the user interface, but can only just touch the surface.  Here’s a look at some of the end-user interface recommendations in the paper that the webinars don’t have time to get into.
  • User-friendly mechanisms to configure risk indicators and their associated weights, thresholds, alerts, and rules.  Complicated calculations (algorithms) may require a wizard-based interface
  • Ability to apply different sets of weights and thresholds for risk indicators, based on the role of user
  • Ability to capture and incorporate feedback from site interactions
  • Ability to create trial-specific visualizations, as well as a library of “standard” visualization templates
  • Ability to customize notifications and alerts (emails, texts, etc.) based on role
  • Ability to incorporate results into study documents, such as pushing the response to identified risks into the monitoring plan
  • Don’t forget about user support – training, web and phone support, and in-tool help

If you’re a fan of integration layer software, you’re well aware that the user interface is the proverbial tip of the iceberg in a complex system.  RBM solutions collect and aggregate data from many types of systems, such as EDC, eTMF, IVRS, CTMS, ePRO, and labs.  The data in these systems have different formats and different standards, and some data, like ePRO, aren’t structured at all.  TransCelerate’s paper provides recommendations to deal with these complexities.  For example, it’s important to be able to verify that an incoming data transfer conforms to the agreed upon standards, and to maintain data lineage so that incoming data is directed to the right place within the system database. The paper also provides recommendations for data hierarchy and organization, management of unstructured data, and real time data updates.

It’s notable that TransCelerate made little attempt to prioritize its recommendations.  That’s hardly a surprise given the variety of forms that a sponsor’s RBM approach can take.  Companies will need to prioritize their own system capabilities lists based on their specific RBM implementation.

An observation: Initially, a company’s RBM approach will drive its technology decisions.  We’ve all seen, however, that once systems of this size are installed and in use, the technology can influence how the business processes they support evolve.

By Laurie Meehan

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