The Clinical Trials Transformation Initiative (CTTI) was created by the U.S. FDA in 2007 with Duke University to solve “a crisis for U.S. clinical research”: Studies took too long to start, not enough patients or investigators were participating, and costs were going up. Today, more than 80 organizations are part of the CTTI, representing government, industry, patient, physician and academia.
Recently, the CTTI unveiled recommendations for the use of mobile technology to improve the quality and efficiency of trials. In mid-July we met at the FDA’s offices in Maryland to discuss them, sharing best practices for how to choose the best technologies, design a protocol, and then capture, manage, and prepare data for the FDA’s review.
I found the meeting incredibly refreshing, because it reinforced the FDA’s position of encouraging innovation from all stakeholders: patients, the pharma industry and its technology partners, as well as academia.
The FDA is proactively engaging industry to find new and better ways to capture functional measurements that matter more to patients. I hear this commitment regularly in the discussions that our partners have with the agency, and I heard it again here.
The project did a great job of balancing both the strategic and mundane, yet important aspects of how mobile technologies can appropriately improve drug development. It’s exciting to consider the ways in which technology can support more patient centric measures and faster efficacy read-outs. At the same time, the data management, infrastructure and validation challenges presented by these tools must be dealt with in way that continues to improve the integrity of the clinical trial process.
The most important message – one I want to help spread – came from Jennifer Goldsack, who helped open the meeting. You can see one of her slides below.
She reminded us that our job is to show as much courage as the patients in these studies do. They’re bravely taking chances in search of medical breakthroughs. We have no excuse not to do the same.
By Chris Benko, CEO, Koneksa Health