Preparing for Trial
A year ago, we reported in this space a sense of “guarded optimism” that permeated the 2013 Neurotech Leaders Forum [NBR Oct13 p2]. The mood at this year’s conference was much less guarded and much more optimistic given the wide range of new funding initiatives, partnerships, and IPOs in the neurotechnology industry [see article p7].
Despite all the good news, though, there are still some areas of concern. As keynote speaker Mir Imran from InCube Labs noted, it still takes upwards of $100 million and 10 years to get a new implantable neuromodulation company off the ground. Much of that cost and much of that delay results from the clinical trial process, which can cost vendors from $30,000 to $50,000 per patient. There is much more that neurotech vendors can do to streamline clinical trials, not least of which is selecting the most appropriate trial participants that will help ensure meeting clinical endpoints.
But there is also ample opportunity for government agencies to step in to help with clinical trials, since any savings produced in this most costly endeavor will reap rewards for U.S. taxpayers. We were encouraged to learn of the new TBI Endpoints Development award, which brings together leading academic researchers with industry leaders, patient advocacy organizations, and with philanthropic organizations [see article p1]. This program is noteworthy not just because the Department of Defense put up $17 million to help fund research on TBI, but also because one of its primary goals is to help participants conduct clinical trials. The aim is for the FDA, through the agency’s Critical Path Initiative, to approve new tools for drug and medical-device development for use in clinical trials. “We believe that by bringing the FDA to the table we can accelerate research,” said Geoffrey Manley, principal investigator and chief of neurosurgery at San Francisco General Hospital.
A major issue in TBI clinical trials has been problematic selection of appropriate participants. Researchers have chosen patients based on blunt symptoms-classification systems. There has also been a lack of consensus about how to define TBI. The new grant will help collaborators develop procedures, outcomes measures, and standards for interpreting clinical data.
We would like to see more private/public initiatives like this for other neurological diseases and disorders that would benefit from streamlined clinical trials. The neurotechnology industry has suffered through some disastrous clinical trial failures, such as the Northstar stroke trial and the St. Jude DBS depression trial, which have impacted other investigators, vendors, and patients for years following the failure. Given that level of interdependency, a greater degree of collaboration on clinical trials among all the stakeholders makes much sense.
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