Working Group Spotlight: Treatment Center Data Management Standards
SCB is coordinating a working group focused on developing a standard on common needs and requirements for interoperability of treatment center data management platforms.
About the Working Group
Data management has been a recurring concern among stakeholders in the regenerative community over the past few years. This topic area has been:
Identified as an area of need by the community
Highlighted at the 2021 Meeting at the Mesa
Brought up by stakeholders in multiple SCB-coordinated working groups, including the Cell Collection Standards for Cell and Gene Therapies and Chain of Custody/Chain of Identity working groups
In October 2021, an effort to develop a standard on common needs and requirements for treatment center data management platforms was initiated. The working group intends to identify the key requirements and challenges for treatment center data management to streamline communication between treatment centers and therapy manufacturers as well as ease the administrative burden on treatment centers.
The Challenge
As new regenerative medicine products are developed, manufacturers often develop corresponding unique treatment center data management portals. Each new portal has its own requirements, including different login credentials and processes. This can prove overwhelming for treatment center staff, as they try to deal with the administrative burden of interacting with increasing numbers of different portals.
As a result, many treatment centers are forced to limit the number and/or types of treatments they provide to keep the portal administration manageable. This is particularly challenging and concerning for smaller treatments centers with patients that require treatment but insufficient number of staff to effectively handle multiple portal interactions.
Accomplishments: Working Group Beginning to Scope the Standard
The working group is currently identifying the best scope for the standard and assessing what portal information is common and can be standardized and what needs to be customizable by company. Potential categories of processes and information to standardize include:
Accounts/access
Patient identification
Patient enrollment
Patient mobilization
Administration
Post-infusion follow-up
Why It Matters
Once developed, the standard will facilitate data management platform interoperability to allow better communication between treatment centers and manufacturers, and ultimately allow more patients to get treatments by reducing the administrative burden on treatment centers.
Why Now
With increasing numbers of regenerative medicine products poised to move toward commercialization and more than 2,000 ongoing regenerative medicine trials worldwide, it is critical to establish a standard as soon as possible to limit the number of portals that would need to be altered to allow interoperability. It is easier for manufacturers to develop new portals in line with a standard than to change portals that already exist.
Get Involved
While the working group currently has about 120 members, additional members are welcome, particularly those with experience at clinical treatment centers or software development companies.
Please contact SCB if you are interested in joining the working group.