What’s really happening with Risk Based Monitoring and trial sites?
Is Risk Based Monitoring a help? Depends on where you sit in the clinical trial process. For example, in a recent Wall Street report, a CRO boasts: “20,000 sites and 250,000 patients now remotely monitored using award winning technology.”
Meanwhile, the Florence Healthcare team met with dozens of sites around the world this quarter, and here’s what we’ve heard.
“Remote monitoring has been on the increase for the last 34-36 months, it’s insidious.”
“There’s a new cost burden, the time my coordinators spend scanning and faxing has gone through the roof.”
“In the morning you might show up and have to root through 250 faxed pages.”
“We have a study coordinator sitting 8 hours a day in a terminal when a monitor arrives.”
So what’s happening? Two separate phenomena are coming together to make life difficult for trial sites:
First, pressured by a decade of cost escalations, sponsors seek cost reduction through Risk Based Monitoring. RBM intends to deliver just this, lowering costs by easing the requirement of validating 100% of data points at 100% of sites. Trouble is, instead of moving away from 100% validation, most CRO+sponsor couplets maintain the 100% goal, electing to reduce site visits instead. This has two negative impacts for sites:
Less advisory support. Many sites appreciate the sponsor visit in support of protocol compliance.
More paperwork burden. Instead of sending a CRA to the site to *help* collect data, sites are asked to organize, scan and fax data on their own on top of their day job.
Second, EHR proliferation makes site data transmission harder today than it used to be. Instead of pulling data from a binder, scanning and faxing, now sites employ a range of Rube Goldberg devices to get data out of their EMR and off to the remote monitor: printing screens, transcribing, copy-pasting (and signing / dating in order to certify source).
Because of the confluence of remote (instead of risk-based) monitoring AND the rise of EHRs, sites’ lives have become considerably harder. This is before factoring in increased recruitment demands and protocol complexity suffered by the entire industry.