Devices & Diagnostics

Still in the renal denervation space? Startups, consider adaptive trial design, CRO says

After Medtronic‘s (MDT) January announcement it’s halting renal denervation trials and BSX and Covidien following suit, the medical blogosphere erupted, proclaiming the “fall” of renal denervation. It seems to be more than a little premature, considering there are other forms of renal denervation than RF (such as ReCor‘s ultrasound method) and other potential uses than for hypertension. […]

After Medtronic‘s (MDT) January announcement it’s halting renal denervation trials and BSX and Covidien following suit, the medical blogosphere erupted, proclaiming the “fall” of renal denervation. It seems to be more than a little premature, considering there are other forms of renal denervation than RF (such as ReCor‘s ultrasound method) and other potential uses than for hypertension. Renal denervation is still a promising technology to be further explored.

However, startups still in the renal denervation space might consider hedging their bets by using adaptive trial designs. According to CRO Aptiv Solutions, which specializes in adaptive trials, they “use accumulating data to decide how to modify aspects of the study without undermining the validity and integrity of the trial.” Put simply: The trial is designed to reassess, and if necessary, refocus at many points throughout a trial.

“It’s trial insurance essentially,” Sherri Dentry-Mabry, director of business development at Aptiv Solutions, said.

For instance, if a sub-population of patients seems to respond with much more efficacious outcomes than the whole population early on, the trial can be adjusted to focus just on those patients.

For startups, Dentry-Mabry said, it can be attractive for potential investors. It takes away some of their risk — they can pull out at certain stages and streamline the process of pilot to pivotal. In fact, the FDA even has given a nod to adaptive trial designs, licensing some of Aptiv’s analytical software, ADDPLAN.

“The FDA very much encourages adaptive studies, and they actually have done a lot of presentations to encourage medical device companies to take on the adaptive approach,” Bernard Sweeney, Aptiv Solutions senior VP of medical devices, said.

But if this is so common-sensical, why isn’t everyone clamoring toward adaptive trial design? (“Adaptive trial design, here, here! Cheers!” I imagine glasses clinking and brusque voices as medtech leaders celebrate at the next Advamed conference.)

Well, it requires often a lot more up-front planning time (and budgeting for that time). It also requires an in-depth understanding of a lot of moving parts, made easier with advanced software, potentially another budgeting concern. And, this comes as no surprise to the medtech industry — that familiar foot-shuffling sound, fear of change.

But, as UMichigan professor and author Jeff DeGraff writes, “Innovation is messy.” Sweeney agrees. Me too.

The more changes needed, the more complicated the planning becomes and likely pricier, particularly if you’re racking up billable hours with a CRO. But for many startups, the changes likely won’t be extremely complex and therefore, the value proposition is obvious: Better to spend more now in time and money than close up shop and lose investor interest due to a botched trial. (Unlike the major players, you might not have cash for repeat rounds of trials.)

And, if worse comes to worst — the trial proves the device isn’t efficacious, you can pack up earlier and with less time wasted and without having lost your shirt.

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