Risky Business at DIA San Diego
It seems like every conference I go to lately (and half of all the emails I receive inviting me to conferences or webinars) has an agenda packed with presentations about risk-based monitoring. “Centralize your monitoring!” “Improve efficiency!” are the call to arms. This year’s DIA Annual Meeting was no exception, with nine sessions alone dedicated to risk-based monitoring (if you search the agenda for the term “risk” you will get 237 hits, so I imagine a few other sessions touched on RBM) – clearly there is something afoot.
I confess I have rarely answered the battle cry and attended many of these presentations on RBM. I decided to spend some time this DIA attending these sessions to find out what all the hubbub is about. And with nine sessions to choose from, I could hear from sponsors, CROs, Transcelerate, the FDA and the EMA (a virtual gauntlet of risk management!).
After a couple of sessions it became evident that the traditional model of 100% data verification across an entire study is just too expensive and inefficient to continue, and does very little to improve patient safety. In the old days of the blockbuster era the industry could afford to throw excessive resources at problems, but, in today’s climate, budgets are much tighter and resources more scarce (the mantra “do more with less” rules the day). And with monitoring making up a significant portion of trial budgets, it’s easy to see why there is so much focus here.
Perhaps the most ringing endorsement came from the FDA and EMA who presented on the regulatory view of RBM with Covance. Both the FDA and EMA encourage organizations to move away from 100% data verification and adopt a more centralized monitoring model.
As I continued to learn, I realized the real challenge is to know where to focus your monitoring activities so you can maximize monitors’ ability to help sites that need the most hands on assistance, and not disrupt those sites that require less oversight. The light bulb went off, at its heart, this is a data problem (something we like at Veeva)!
In order to implement an RBM strategy, a sponsor would first have to conduct a risk assessment at the beginning of the study to determine where their monitors should initially focus their attention – the strategy also needs to be flexible enough to change direction during the course of a study if need be. To do this properly, requires knowledge of site performance.
Visibility across a complex global ecosystem that includes sponsors, CROs, sites, etc. and consistent processes are then vital, and there are few systems that touch all these partners that directly impact monitoring. A historical reticence to embrace cloud technology also makes many of those legacy systems extremely expensive and limited to large organizations. And even those organizations that can afford to utilize such systems oftentimes aren’t leveraging metrics to improve trial design and execution (we just published the results of an industry survey that made a clear case for the benefits of metrics collection, but also highlighted how few organizations are actually taking advantage). It’s not uncommon then for organizations that may want to adopt an RBM strategy to not even know where to begin their risk assessment.
While I was enjoying my DIA complimentary caprese sandwich on very dry focaccia and ruminating on these sessions, it occurred to me that there is a strong argument that cloud eTMF applications like Veeva Vault eTMF are one of the few systems that can collect meaningful data across the entire study ecosystem (I know it takes awhile, but the wheels do eventually turn). By automating key processes like site activation, sponsors would have a strong understanding of which sites need help onboarding. From the very outset of the trial the sponsor would know where to focus their efforts, meaning fewer monitors, fewer monitor visits, fewer site disruptions, and more efficient studies. And study start up is just one process that can be configured on an eTMF.
There is a goldmine of data to be unlocked from eTMF applications that can truly revolutionize the way we conduct clinical research. Risk-based monitoring is one area where the immediate benefits are too large to ignore. We are just beginning to scratch the surface and as the industry more and more adopts eTMFs (that same survey showed that only 13% of organizations have used a cloud eTMF application like Veeva Vault eTMF) the faster sponsors will accrue these benefits.
My decision to spend a good part of my three days in San Diego focused on risk-based monitoring turned out to be an excellent use of my time. My interest is definitely peaked and I can see many ways in which Veeva can play a crucial role in these emerging strategies. I’ll be spending a good time over the next few weeks combing through my inbox for all those ignored webinar invitations (sorry!) and looking at upcoming conference agendas to get deeper into the conversation. If you have any resources you recommend, please send them my way. And I’ll make sure to share more of my thoughts on eTMF and risk-based monitoring in this blog as I learn more.