What part do you see Data Management playing in this changing tapestry with RBM at the helm?
Updated: Mar 25
There is no doubt that the Data Management function has a unique vantage point in terms of layout and timing of data. Sites enter one visit at a time. Data Management can see all visits entered into EDC in one comprehensive listing.
Biostatistics sees all data at once too. But the database is probably locked, the subject is gone and the site is closed now. Most data cannot be queried, clarified or amended at this point.
If you require identification, communication, clarification and correction of data issues in real time, your money would have to be on Data Management. Which puts huge pressure on Data Management to get it right. They can’t be caught napping. In addition, the Risk Assessment, identification and mitigation now becomes one of its critical responsibilities.
In nature, animals that live in packs or tribes often have one member on ‘guard duty’ to keep a look out for risks to the pack. This member of the pack will usually climb to a higher level than the other animals to keep an eye out in all directions. North, South, East West, Up and Down. Why does the monkey need to climb higher than the other members of its tribe? For a vantage point. A holistic view. The bigger picture. The ability to alert others in time for them to be able to protect themselves from oncoming threats.
Data Management is very much that guardian monkey responsible for the survival and success of its tribe. The tribe would never select an inexperienced monkey for the position. If the guardian monkey dozes or misses an oncoming threat, the tribe will suffer. Suffering in our industry may take the form of delays of upto years, data too inaccurate or illogical for analysis, trial costs way beyond allocated budgets, or rejection by a regulatory body, resulting in unavailability of a new drug for patients who could have had a better quality of life.
What RBM is NOT, is just targeted SDV and remote site monitoring. RBM refers to the ongoing identification and monitoring of risks to the ENTIRE trial. And the function best poised to do this will always be the one with the best view from the top of the mountain.
This is an excerpt from the Executive Director's interview with the organizers of the GCT Meet held in Barcelona in 2018.