Comprehensive Data Transparency & Anonymization Support
In 2013, a top 5 pharmaceutical company was introducing a corporate initiative for greater data transparency to the external world, allowing clinical trial data to be available to the public domain with the challenge of maintaining patient anonymity yet preserving data integrity. Patient data transparency and anonymization was a brand new area in industry with limited guidance or precedence for how to implement a solution. The pharma company approached MMS based on a history of providing high quality SAS programming resources.
Planning, Technical Expertise, & Implementation by Skilled SAS Programmers
MMS provided 3 FTE SAS programmers to support patient data anonymization for clinical study data across corporate divisions. MMS was instrumental in working across divisions at this organization to create data anonymization standards, build consensus across a wide variety of divisional/organizational needs, create a process that would allow anonymization to be conducted quickly and routinely for a large volume of studies, and provide the technical/SAS programming expertise to build the anonymization program itself. The MMS team immersed themselves in the policy requirements, reviewed what other pharma companies were doing to address the issues, and utilized their experience to come up with customized innovative solutions to best meet the client needs. MMS contributions provided a great deal of value and innovation, including the below accomplishments of the team:
- MMS suggested a pilot to anonymize a single study in parallel with development of the global process. The MMS team anticipated queries from the project team and proactively provided a Visio process map of an abbreviated process flow to provide transparency to their activities. The pilot was successful in allowing anonymization work to begin quickly, but to allow flexibility to adjust the process if needed.
- MMS proposed a detailed and comprehensive user acceptance testing document that was aligned with the actual project needs and brought attention to a variety of issues that were previously overlooked.
- MMS created a SAS macro to introduce additional security into the data anonymization process (a “wrapper” macro)
- MMS proposed the following process optimizations that enhanced efficiency for all stakeholders:
- Creation of pre-defined anonymization modes for standard study data variables, which increased efficiency for each study team by 50-60%
- Maximized efficiency for the study teams by streamlining touchpoints for their inputs into a single questionnaire issued at the initiation, rather than multiple occasions of information gathering throughout the anonymization process
- Created voice over power point training for study teams, saving time for both the client and MMS
Innovative & Customized Long-Term Solution to Clinical Data Transparency
The MMS team was flexible in their approach, utilized a variety of sources to create customized and innovative solutions, and understood that clear communication of ideas and process was the most effective way to ensure the proposed solutions truly meet the demands of the project, as well as to ensure that consensus was reached more quickly. By working in this way, MMS champions innovative solutions that are sustainable, adaptable, and continue to meet changing project needs. As a result of the great effort by MMS, the team has grown by 3 additional FTEs, has been established as long term client solution, and remains in place in 2016.
For further information about Data Transparency and Anonymization programming leadership and support, please contact MMS at firstname.lastname@example.org.