Total data points collected in a typical Phase III Protocol have nearly doubled since 2005, Ken Getz, founder and owner of CenterWatch, told attendees at ACRP’s 2016 Meeting and Expo today.
Between 2001 and 2005, sponsors sought 494,236 data points in a typical Phase III Protocol. Between 2011 and 2015, CROs had to contend with 929,203, according to statistics collected by Tufts CSDD, DRI, and Medidata Solutions. Getz is also Director and Associate Professor, CSDD, at the Tufts University Medical School. “The increasing complexity of clinical trials is challenging,” he noted.
Making matters more challenging, there’s an increasing trend among Sponsors to spread their business around. The result? “More sites are being employed but they are being asked to recruit fewer patients.” Obviously, that’s not the business model of choice for the site.
There’s also a frustrating communication disconnect between CROs and Sponsors, Getz reported. Only 14% of CROs say they have the opportunity to regularly participate in upfront planning and study design, according to a 2014 Tufts CSDD report. More than half, or 64%, also believe amendments and scope changes could be decreased if they had more input.
That’s not how Sponsors see it. According to the same study, 38% say that their collaborations with CROs consistently fail to meet cost and cycle time expectations.
The most troubling statistic of all? Half of Sponsors and 60% of CROs flat out concede they cannot effectively collaborate. That’s a tough environment in which to evolve together and work most efficiently within new market realities, Getz said.