DIA Recap of Risk Based Monitoring

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This guest post and DIA recap has been provided by Lorraine Mercer, Lead Clinical Data Manager.  Did you attend DIA 2014?  Which sessions were most worthwhile?  Would you like to blog about the big takeaways? Join our discussion at LinkedIn.


A Recap from Lorraine

Attending DIA 2014 this year was a wonderful privelege but it was impossible to absorb it all. This is my DIA recap. For any given timeslot, up to 10 offerings or conference sessions and various seminars were offered. I downloaded the app on my iPad in advance and that helped me stay organized so I didn’t miss the sessions I was most interested in or any important meetups (so handy!).  There were 7000 people in attendance for the 50th anniversary year of the DIA. and I was able to meet so many interesting people from the UK, Australia, Japan and from across the USA.

Risk Based Monitoring (RBM)

The major topic in my DIA recap and the learning modules this year was Risk Based Monitoring (RBM). An interesting variety of vendors and also companies that implemented the RBM model presented.  RBM was the focus in the seminars that I attended during the DIA meeting. Read the actual guidance here:

The FDA Guidance A Risk-Based Approach to Monitoring Document (Link)

The RBM Guidance was posted in August 2013. Now, nearly one year later, RBM was definitely a hot topic at DIA.  One of the FDA presentations addressed many questions and provided further summary. I especially enjoyed hearing from several companies presenting their experiences in already implementing RBM.  For further review, the presentation slides are available online at the DIA site for a short time. However, slides are not available for all of the seminars and workshops.

Debriefing the best sessions for you

I attended 4 days of seminars on the topic but here I will attempt to condense the takeaways in this DIA recap:

RBM is the methodology of balancing quality with risk:

  • Quality – The absence of errors that matter in decision making.
  • Risk – adversely impacts Quality

Opportunity versus Threat

Some CRAs are worried that RBM might reduce the need for their role.  One of the shared learnings was that 100% SDV does not mean quality data. SDV is check boxes and the task can be mind-numbing. Because of the repetitive nature of SDV, the process is prone to errors.All of the data may not be reviewed. For Example: Does a data point make sense when compared to other data points? RBM does not mean less data is SDV. RBM promotes Clinical Source Review. The data is reviewed as a whole. Did the subject meet all the inclusion / exclusion criteria when the screening data is reviewed?

Lilly Ran a Pilot

The Lilly presentation by Nichole Sheetz was valuable because this company actually implemented the RBM pilot. Therefore Lilly was able to share real metrics on the pilot results. Lilly supports the RBM model and has already realized 20% cost savings on study development.  The pilot was returning positive savings quicker than expected. The company quickly escalated the pilot to include a greater percentage of studies.

The RBM Process

Data -> Issue Management -> Query Resolution

The Central Monitoring model is trigger-driven by the number of queries and the number of patients at the site. Other triggers could include:
• a new coordinator
• a high rate of issues at one site
• a high rate of screen failures
• a high rate of enrollment and / or
• a high rate of drop outs

Source Model for RBM:
• Central Monitoring
• Lilly started with 3 models in pilot ( now down to one preferred model)
• Which model was most effectiveness and efficient
• Capability and scalability

Processes were aligned across Source Monitoring and DM patterns
Lilly did a Global pilot which included 3 Japan pilot studies.

Central Learnings

• Source data and Data Integration must be consistent across the DM systems
• Business ownership such as Data Rules and standards
• All the systems are assessable by central monitoring
• Must have visualization and detection; new tools available
• CTMS is needed for site monitoring has to be consistent. Sponsor cannot use the CRO CTMS. There are too many variables between CTMS systems.
• The CTMS has to be centrally maintained and accessed
• Training and standards are needed

BMS Commitment to RBM

Bristol Myers Squib Phase I – III  experience in RBM was presented by Brett Wilson, Director.  RBM is implemented 100% RDM at BMS. There are no pilots.

TransCelerate’s joint presentation with BMS stepped through their approach and success.  The focus is on “Errors that Matter”. There are 2 – 3 monitor visits at site. If this is a high risk site more visits may be needed. The company estimates that maybe 6 monitor visits a year are needed.

BMS does not believe that RBM fits the description for Remote Site Monitors. Data Issues cannot be reviewed in someone’s home. The cost saving is realized from the reduced monitor visits. However, additional process training is essential. The current CRA model according to BMS is going away. Sites have a clear expectation of the processes in place to meet the expectations.

BMS is seeking a higher knowledgeable Clinical Source Reviewers. The CSR is a cross between the CRA and DM, or a Central Monitor. The CSR can do Source Review, review the analytics and query the data or determine if a site visit is warranted.

Data Managers will have a bigger role in generating and reviewing metrics and reviewing the data.

Are you ready for RBM?

Now is the time to seek training so that when RBM arrives at your company you will be ready.  Did you make it to DIA 2014? What did you think? Did I capture the highlights in this DIA recap? Leave a comment  or join the conversation in the ClinOps Toolkit  LinkedIn Discussion group.


About The Author

Lorraine Mercer

Lorraine Mercer is a Lead Clinical Data Manager at a San Francisco Bay Area oncology company. She has over 15 years experience at a variety of pharmaceutical companies and CROs. Prior to completing her BS in Computer Science, Lorraine worked as a nurse in the Surgical Intensive Care Unit for over 10 years.

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