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Design Impacts RBM

By Penny Manasco - December 28, 2016

I recently finished reading the New York Times Design issue. The creativity industrial designers use to make processes work more smoothly is truly inspirational.  The quest to make systems work more efficiently is their raison d’etre.
Many articles in the issue inspired me, but one, a redesign of the prescription handout was particularly relevant to discussions about data visualizations and their importance in analyzing study performance. Thomas Goetz wrote an article about how Periscopic redesigned a patient product brochure from a 10,000 words package insert to a one page document. It contained all of critical data in easy-to-interpret pictures and text that someone will actually read and use.  The redesigned brochure included:
  • Name of the medication, what it looks like, what it does
  • How to take your medication (timing, with meals, amount of dose)
  • What you can expect (side effects, including timing related to starting the medication) and timing for efficacy
  • Any restrictions to activities
  • Any contraindications
  • When to seek medical advice
MANA RBM has also been busy at work in RBM industrial design. Our proprietary Subject Profile Analyzing Risk (SPAR) was the subject of a peer-reviewed paper just published by Applied Clinical trials online ( After you read it, please contact me if you have any questions, comments, or want to discuss any RBM issues.
In that paper, we presented data on enhanced source data review using the SPAR. The tool is one component of the MANA Method, which incorporates the technology tools and processes of total quality management (including RBM) with comprehensive remote trial management. 
The SPAR allowed monitors to perform rapid, integrated review of critical data items identified during the risk assessment process.  An individual subject review of all critical data took an average of 1.9 minutes/subject, rather than the 8.7 minutes/subject when using simple eCRF review or listings reports. The review also took 99.4% less time than an onsite visit. 
How RBM is implemented is critical. The Guidance from Regulators (FDA, EMA, ICH) emphasized the importance of reviewing data rapidly to identify errors that could affect the integrity of subject review. The bad press RBM has been receiving is likely due to the way an organization designed its RBM process, not the principles of quality management. 
For instance, simply scanning source documents to perform SDV remotely is not sufficient oversight based on published literature. In addition, it doesn’t get to the core of the oversight issue. Point to point checking of individual data items in individual data sets (e.g., vital signs), does not allow the comprehensive view of a subject’s progress in a trial that can be achieved with tools such as the SPAR. If you don’t have a comprehensive view, how can you truly understand issues at a subject level?
If you only look at data at a subject level, you miss important quality indicators only identifiable with a systemic approach to evaluating data across subjects and across sites. Capturing that evaluation and managing the resulting issues including follow-up and root cause analysis are integral  parts of the review process for a trial.
Good design can be the difference between a 10,000 pages document that no one reads and a one page document that provides the critical data to understand how to take a medication.  It can be the difference between sending armies of monitors to sites to do point to point data checking or having a small team focused on remotely evaluating critical data as soon as a subject is seen in the clinic. In both examples, good design allows for more informed, “integrated” decision making. 

For more information about the MANA Method of Risk Based Monitoring and Remote Trial Management, including the innovative tools and processes adopted to assure compliance with the new ICH E6R2 definition of Good Clinical Practice, contact Dr. Penelope Manasco, M.D.  at