Cari Kniola
Senior Director, Corporate Strategy

February 14, 2022

Well, SCOPE 2022 is over. There was a lot packed into a few days! Before the conference, I talked about some RBQM information I hoped to get out of SCOPE 2022:

1. An update on Risk Based Quality Management (RBQM) adoption and where pharma and biotech companies are in the process
2. Hear about others’ RBQM journey – their struggles with implementation, lessons learned, technology adoption, etc.
3. Dive into data analytics as part of the RBQM process
4. Get the low-down on RBQM and small, early phase clinical studies

I’ll talk about our wish list in a moment (suspense!), and first touch on SCOPE 2022 in general.

Everyone we talked to at SCOPE 2022 said the same thing – how happy they were to be seeing people, and how much they missed it. It reminded me of when I went to Disney World last spring. It had just opened back up after being closed for months, they were only letting a certain amount of people in, and you had to wear a mask and stand 6 feet apart in lines for rides that stretched forever. But instead of the stressed, overstimulated feeling that often comes with The Magic Kingdom, people were just happy and grateful and appreciating being able to go at all. And sure, SCOPE may not have Space Mountain, but still – the people we talked to over the last few days were simply happy and grateful to be seeing faces in person. We commiserated about figuring out how to dress up again and having to wear uncomfortable shoes, told stories of lock-down times and dealing with kids and dogs perpetually in the background. And most importantly, we escaped the tunnel vision that is bred from isolation and shared ideas, knowledge, and experiences that can really only come from being face-to-face. Sure, at some point we’ll start grousing about conferences and how exhausting they are again (I’ve been to Disney World again since last spring and the grousing has definitely re-commenced there). But for now, it’s pretty magical to see the appreciation for the in-person life.

Back to our wish list. Let’s see what we were able to check off:

(1) RBQM adoption: There were a fair number of presentations that were what I would call ‘Intro to RBQM’ and provided very useful information for pharma and biotech organizations that might be early in the RBQM process. For those that are well into the process, we may have been hoping for a little more meat. It’s not that the meat wasn’t served – there were presentations that dug into some weighty topics like Decentralized Clinical Trials (DCTs) and RBQM, finding the right central monitoring team, inspection readiness and RBQM, and others that provided excellent experiences from those that have been travelling the RBQM path for years. While the wide range of assumed RBQM knowledge base made it seem a little hit or miss on whether a presentation would be useful to an individual listener, it likely reflects where the clinical research industry is as a whole with adoption. The majority of presentations were on earlier adoption topics, and that matches with what I have heard about where companies are with RBQM, with only ~20-25% or so really all-in.

The July 2021 article “Risk-Based Monitoring in Clinical Trials: Past, Present, and Future” goes into detail about where mature companies are in their RBQM process based on survey responses. In summary, while there were over 30% of companies that had incorporated initial and ongoing risk assessments, only 25% included centralized monitoring and only 9% had incorporated all of the RBQM/RBM components, inclusive of reduced Source Data Verification and QTL/KRI monitoring. So, while it took some conjecture to get there, I do think I have an answer to this question about RBQM adoption (and it doesn’t seem like it’s changed much yet!). I would love to hear from others about their RBQM adoption and where they are in the process, in particular with small to mid-size pharmas and biotechs.

(2) Where others are in their RBQM journey and lessons learned: These are a few of the take-aways from presenters that have ‘been there, done that’. As a company that has been on this road for the last two-plus years now, it’s always validating to hear similar experiences, but it’s even more useful to hear things that we hadn’t experienced or thought of yet!

• Embed RBQM into your inspection readiness process – one example provided was storyboards of issues that had links to documents in the eTMF that helped tell the story from start to finish
• RBQM is not ‘cut and paste’ – there may be some indication-specific risks that can be part of your library, but this a study-specific process
• Provide your team with a RBQM workshop setting that provides a ‘safe space to fail’ as they get comfortable with the process
• This is not an overnight process! Expect years to get comfortable, iron out processes, and an ongoing evaluation of what works and what doesn’t.
• Successful central monitoring teams are made up of individuals with innate curiosity and critical thinking skills and facilitate the RBQM process
• DCTs go hand-in-hand with RBQM and provide another source of data that must be incorporated into centralized monitoring

(3) Data analytics and RBQM (more than Quality Tolerance Limits or QTLs): From a QTL/KRI/centralized monitoring perspective, the importance of incorporating all of the data streams (in particular with the rising popularity of decentralized study components), some of the ways you can use centralized monitoring to evaluate a change in processes, and the importance of a skilled centralized monitoring team were topics that were touched on several times throughout the presentations. My hope was to dig even deeper into ways you can visualize the data and use it to assess outliers, unexpected trends, etc. I have some homework to do with this one, mainly because I was firmly settled in the SCOPE RBQM track, and I think some of what I was looking for was in the data analytics track. Very thankful I can listen to some of the data analytics presentations I missed to help check this box!

(4) RBQM / data analytics and smaller, early phase studies: I asked around about this and didn’t get definite answers, just that it is being seen more and more. It is a given that the initial and ongoing risk assessment process should be done for all studies. But how deep do you go with the data analytics in a small early phase study, like oncology dose-escalation studies? Or a small study that is a slow enroller? We think these small studies make each patient precious, and therefore, overall data quality and proactively identifying issues that would keep a patient from being included in the final analysis even more important. I would love to hear thoughts from others on this topic.

So, in the end, I left the SCOPE 2022 conference 50/50 for my wish list – likely up to 75% after I do my homework. Even if I don’t get the whole scoop I was after, I more than made up for it with meeting new industry friends, seeing some that I hadn’t seen in years, and celebrating being a part of an industry that is filled with innovation, passion and a drive to consistently improve our methods for bringing treatments to the patients that need them.  Overall, I consider that a rousing success.

Share your thoughts with me regarding best practices and the future of RBQM and Data Analytics.