At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The conference, which I attended in Boca Raton, FL, attracted over 850 industry professionals from sites, sponsors, and CROs. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends.
This year the survey generated 463 responses from sites of varying sizes, with 72 percent of them coming from SCRS members and the majority (83 percent) originating in the U.S. Respondents are also experienced in the field of clinical trials. Over 40 percent worked in a practice site and 75 percent have been in operation for more than 11 years. Seventy percent of respondents conducted more than 11 studies in 2015 alone.
The first thing SCRS hoped to determine were the factors that help sites to remain sustainable. When asked about the most important factor related to sustainability, it’s no surprise that the top response was a lack of study opportunities. That was followed closely by uncompensated activities, staffing, and cash flow. Recruitment and pricing rounded out the top six. It also comes as no surprise that three of the top four concerns related to sustainability are directly affected by sponsor and CRO partners. Opportunities and payments were also common themes that surfaced multiple times throughout the course of the Summit.
SCRS often asks members what they need to do to become the site of choice for partners. Meeting timelines, enrolling eligible patients, and providing quality data are always the top responses. Do those three things, and do them successfully over and over again, and sponsors will love you. As Pierre noted, it sounds simple, but at the same time is not so simple.
Are Partnerships Getting Better Or Worse?
Of course, for sites to successfully perform those three tasks repeatedly, the six roadblocks to sustainability would first need to be reduced or removed. For that to happen there first has to be a true partnership that exists with sponsors and CROs. This is where the survey results get a little disconcerting. Respondents were asked how those partnerships have changed over the last two years. Thirty-one percent said their sponsors feel like more of a partner, while 29 percent said they feel like less of a partner. The numbers were worse when applied to CROs: 25 percent of site respondents felt like they were more of a partner, and 39 percent felt like they were less of a partner. For all of the companies claiming to want to be a sponsor of choice, you might have expected those numbers to be more positive.
“It saddens me to know that sites are not feeling the appreciation in terms of the willingness of sponsors and CROs to partner with us,” said Pierre. “Perhaps the outreach activities being performed by these partners are too new for sites to see the results of them. But as an industry we really need to discover what is causing those pain points, and what we need to do to push those positive numbers higher.”
One thing sites prefer, and which may help to strengthen partnering relationships, is face-to-face meetings, which were cited by a majority of respondents as the preferred medium for sponsor-required clinical trial training. That medium far outpaced self-directed modules, video and teleconference, and paper-based training. Pierre attributes this to the desire of professionals to network.
Sponsors Really Do Care
Despite some of the negatives related to partnering that came up in the survey, Pierre stressed that sponsors and CROs really do care about sites. She referenced a slide showing more than 25 titles held by professionals at sponsors and CROs that all relate to site relationships. They range from director of site alliances to VP of site and patient networks. “If, as a site, you don’t feel the industry is listening to you, rethink that,” Said Pierre. “Sponsors and CROs are creating departments to address their partnerships with sites. They are being put in place to support sites and our efforts.”
Still, there is more that partners can do. Pierre referenced an observation by Peter Ronco, VP of global operations for BMS, in which he noted sponsors should focus on making customer service something that is built into every site interaction. Two key components of that customer service model are having site-facing staff in place and putting an increased focus on flawless execution. The execution aspect means having kits in the right place at the right time, EDC systems that are easy to use, study-in-a-box (one box containing everything needed for a patient), and technology that can scan, track, and inventory medicines and supplies.
“We are not there yet, but I do think we are headed in the right direction and will get there,” says Pierre. “It’s exciting to think about. The relationships are changing and they are evolving and improving.”
Sponsor, CRO, and site relationships certainly need to improve. Protocol complexity has been increasing steadily since the year 2000. At the same time, site profit margin, staff ROI, and the average site payment per patient visit have all been declining. Add in the fact that many partners still pay sites quarterly (a practice sites say will negatively impact the results of a study) and we see there is ample room for improvement. In fact, 80 percent of sites state they prefer to be paid monthly, even though 60 percent still report being paid quarterly. If partners can heed the advice of Ronco, relationships will improve. And anything that can bring sponsors, CROs, and sites closer together will ultimately lead to better trials, a better patient experience, and medicines in the hands of patients faster.