SCDM 2017 – RBM chair Abby Abraham of Algorics reflects on his session with panellist Mark Paul, President, North America CROS NT, and the lessons learnt from RBM implementation.

With the SCDM 2017 conference now complete, I’m able to reflect on a fantastic event successfully brought together by the SCDM organisers.  This event always brings a unique blend of deep knowledge and content, combined with speakers who have an eagerness to share their expertise and hands-on experience. This year’s agenda brought together regulatory, pharma, biotech and industry insights to keep industry delegates informed and entertained.  As a session chair, I was delighted with the development of my session, ‘What can you expect from the Fail-Safe Central Data Monitoring in RBM – How Do We Achieve It?’ and in today’s blog, wanted to introduce you to Mark Paul, CROS NT, who shared their real-life experiences through a case study and discussion around the success factors and challenges of RBM implementation.

Introducing: Mark Paul, President, North America, CROS NT

Presented: Tools and Processes for Data-Driven Monitoring and a Risk-Based Approach

Implementing Risk-Based Monitoring from a Data Perspective: Part I

Each sponsor and their partners enter the RBM (Risk Based Monitoring) process at different places.  Now that the new version of GCP (ICH GCP E6(R2) addendum) mandates risk-based thinking, all of us in clinical trials need to embrace risk-based processes. 

What exactly does this mean?

We need to begin implementing risk assessment, risk measurements, task level action and tighter linkages of Data Management and ClinOps in particular.  At CROS NT, we’ve had experiences with a variety of teams involved in implementing RBM. 

Case Study: Implementing RBM from a Data Perspective

CROS and one of its sponsors started fairly simply.  As their pilot RBM experience, our sponsor chose a study that was quite low risk: an open label extension, but one that was key on the development path for a particular CNS candidate molecule.  The key data was safety information looking at 24-month exposure data and real world experience regarding concomitant medications.

The team decided to implement RBM initially as a metrics-based approach focused on the study’s readily available EDC data.  CROS and the sponsor began with a series of meetings reviewing the Transcelerate RACT model and adapted it to our needs.  We reviewed the CRF together as a team and pulled out 8-10 key variables for our RB metrics.  This process encompassed a month of weekly meetings.

We set our goal as less than 10 key data fields to put into our risk plan.  We purposefully did not want to over-complicate our first experience using risk-based tools when deciding on a data review plan for setting clinical monitoring priorities.

Initially we focused on a metrics or threshold-based analysis.    We selected the key measures you would expect, including adverse events and serious adverse events, along with other measures like con med usage and an investigator’s global impression score.

After selecting the appropriate data, CROS built a series of queries in the Sponsor’s EDC system to produce the raw metrics data.  We interpreted this data and merged it with the historical RB metrics data to keep a three-month rolling view of the key variables.  We color-coded the data where significant changes happened comparing month-to-month data to highlight new or changed information.

The team had an iterative process for the first few months.  We needed to balance the goals of the analysis against the data availability.  In a few cases, we learned that some of our anticipated measures could not be easily derived from the EDC data without revisions to the system configuration.   We opted not to invest in re-work of the EDC setup to make some of the meta-data available to the RB metrics analysis. In the future, the sponsor will implement a standardized approach to EDC system setup that will provide better data to the metrics analysis.

We were in a planning and definitional phase for 2 months and we’ve been producing and using the metrics analysis for the last 10 months.  The joint CRO and sponsor team has learned a lot together about the terms, the process, and usefulness of using a risk-based approach to data review and monitoring practices.  This close collaboration is ideal to a successful RBM implementation.

More about Mark Paul

Mark has served in progressive management positions in the clinical trials industry for over 24 years. He began his clinical research career in the CRO environment as a programmer and project manager and served in project management, business development, and information technology functions. Mark was Project Director for several NDA submissions and global clinical trials, and he has served as department head of data management, clinical operations, and business development groups as well as Director, eClinical Technologies for a major CRO. In addition, Mark occupied the role of CEO of StatWorks, Inc., a data and biometrics focused CRO, for over 8 years.  In his most recent role before joining CROS NT, Mark was a Managing Partner and head of sales and marketing for Veracity Logic.  He holds an MBA from the Kenan-Flagler School of Business at UNC-Chapel Hill and a BA from the College of William and Mary in Virginia.