Category 4: Identifying the Right Metrics

A robust set of metrics would greatly help to properly assess the benefits of RBM implementation in the long-term. The definition of an RBM output considered “acceptable” needs to be defined by each sponsor company and the sites with which it works based on their experiences implementing RBM plans, combined with input from health authorities. The value of Centralized monitoring and the pathway to predictability of RBM will be enabled by this definition of, and agreement within the organization, on critical success factors.

In its RBM Position Paper, the TransCelerate team developed and published eight core metrics in the categories of quality, timeliness and efficiency, but whether these will become widely accepted within the industry or if there will be improved ways to measure RBM impact remains to be seen.

Metrics can be complex and need to be carefully developed, particularly when being compared to e.g., comparing site audit findings post-RBM would not be clear if the sample is based on a targeted selection of sites whereas the historical baseline performance was based on random selection of sites.baseline data. Sponsor companies obviously may consider additional measurements such as:

With expanding implementation of RBM to broader reaches of the industry, organizations will have the ability to measure these and other performance metrics in a macro rather than anecdotal way, and make adjustments to RBM methodologies as appropriate.

Key to this is encouraging sponsor companies, investigative sites, CROs and technology companies to openly publish and share success and failure of various RBM models and technological solutions. By sharing results, we will move the needle on RBM metrics. And by utilizing metrics, we will improve our understanding of, and success with, a holistic and proactive RBM system.

TransCelerate’s RBM Initiative is continually evolving, so additional content and materials may be added to this guide in the future. Please stay tuned and stay connected for future updates!