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RBM Adoption – Taking the Industry Pulse

Posted by Steve Young on Jun 11, 2015 5:15:00 PM

OmniComm recently conducted a well-attended RBM webinar during which we polled the audience regarding their organizations’ progress with RBM adoption. The following two questions were asked in particular:

Which one of the following best describes your organization’s current level of RBM adoption:

1)      Fully implementing – Most new studies expected to use RBM
2)      Piloting – One or more initial studies using RBM
3)      Actively Planning – First use of RBM expected this year
4)      Exploring – Definite RBM Interest, gathering information
5)      No Current Plans – RBM not a current priority

What do you see as your organization’s single biggest barrier to successful RBM adoption:
1)      Fear of increased regulatory/audit risk
2)      Fear of potential degradation in quality
3)      Lack of team consensus on RBM value
4)      Perceived complexity/burden of RBM implementation

We analyzed the results, using only those responses provided by representatives from CRO or sponsor organizations (some responses were provided by consultants and vendor representatives). A total of 46 responses were provided to these two questions, representing 29 different clinical R&D organizations – 16 sponsors and 13 CROs.

The first graph below presents the results to the first question regarding current status of RBM adoption. For this graph we consolidated the responses to a single response per organization, removing duplicate/multiple answers that came from some organizations.   While there were 0 responses for “No Current Plans”, it should be noted that there is some built-in bias in these results given that participation in an RBM webinar pre-supposes at least some level of interest in RBM. Nevertheless, the results indicate a significant movement forward in the industry towards active RBM adoption. 45% (13/29) of organizations already have ongoing RBM studies, and another 31% are planning to initiate RBM studies during this year. It is interesting to note that only 33% (4/12) of CROs are already implementing RBM, compared to 53% (9/17) of sponsors. This result re-enforces the relative hesitance that many have observed from the CRO industry with respect to RBM.   The value potential of RBM is often less immediately recognized by CROs vs. sponsors, and many instead perceive a threat to study revenues related to site monitoring. Given the inevitable full adoption of RBM methodology across the industry, CROs who pro-actively embrace this new paradigm will undoubtedly see a competitive advantage in the coming years.



Results for the second question are presented in the next graph below. Since there was not general consensus observed for multiple responses within each organization, we tallied the results by individual respondent rather than by organization. The results are very striking, with 63% (29/46) of respondents indicating that perceived complexity and/or burden of RBM implementation is their organization’s single biggest barrier to successful adoption. 


This result reflects what we at OmniComm also have assessed to be a key challenge for organizations moving forward. There has been a significant volume of RBM methodology guidance and advice emerging over the past couple of years, following the regulatory papers issued by FDA and EMA. And while much of the advice has been helpful, there has been an unfortunate – and mostly unintended – level of over-engineering in this methodology support. Our OmniComm RBM consulting team understands the source of this over-engineering, and have developed a methodology framework that is helping our clients cut through all of the guidance and focus on a simple, smart approach to ensure RBM success.

We’re very interested to hear from you on these results. Where is your organization with RBM adoption, and what do you believe are the biggest challenges moving forward?

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Tags: Risk-Based Monitoring