Five years ago, when Christine Pierre attempted to bring together clinical investigators and other site leaders to casually discuss their best practices, it didn't go as she'd hoped. She sent out 1,000 invitations. Representatives from ten sites showed up. “In all honesty, it was a huge failure,” says Pierre, president of Baltimore area-based RxTrials, a 16-year-old site network.
And yet, the handful of site leaders met anyway for a weekend in Santa Fe dubbed the Site Solutions Summit, and dug in on annoying issues that are universal to sites, casting about for remedies. Then they went home.
But that gathering was not a failure after all. Word of the meeting spread. Other site owners, directors and investigators got jazzed about what Pierre was trying to accomplish. The Association of Clinical Research Organizations (ACRO) even contacted Pierre and said it wanted to be involved.
Before that second meeting, Pierre decided to send out a survey. The purpose: to collect interesting metrics for sites to discuss at the upcoming meeting. The sites answered her. And how.
“The information was amazing,” she recalls. “I asked things like: how much staff do you have? What's your profit margin? What's your non-refundable up-front? We started gathering all these business metrics that no one ever had. Sites answered whatever we asked. We had really tapped into something.” Her goal is to elevate the way business is done across all industry-sponsored research, but to especially help the 450 or so sites considered the backbone of the industry.
Prior to her efforts, she believes, there had been no other way for sites to benchmark themselves. Says Pierre, “Now sites can say, via the survey results: my profit margins should be X, and I should pay investigators X, for example.”
Pierre continued sending out the survey each year. And sites don't just answer based on what they can recall. Instead, they are are asked to pull 10 studies from their files and gather actual metrics. “They give me the real metrics and share real financials,” says Pierre. “Like, what's the return on investment for each coordinator? How many studies can each coordinator generate? Each time, we pick three or four areas and really drill down.”
The second meeting, in Clearwater, Florida, was a raging success. ACRO and RxTrials co-sponsored, with several ACRO member companies sending site-selection employees to speak on panels. Sixty-three site stakeholders showed up and Pierre went from inviting every site she'd ever heard of to being strategic. Now only seasoned sites, with decent trial volume, get invitations. She also decided it was important to have a good variety of academic, free-standing and physician-office sites. The Site Solution Summit was on its way, with participants sharing just about everything.
“People who are new to the meetings are astounded at how open everyone is in their conversation,” says Pierre. “I tell sites: when we talk about how we run the sites better, why do we feel it's intellectual capital, or private? It's not. Other industries share best practices to help make their industry better. Why don't we?” And if attendees don't share, Pierre nudges them. “I don't let people sit there quietly,” she laughs.
Pierre explains that each meeting focuses on a few key operational directives for sites. They might sound obvious, and maybe they are, but many sites don't keep them front and center, she says. For instance, in year two: For every study, sites should have a primary and a back-up coordinator. “It sounds simple, but it's huge; If your coordinator leaves, the study is dead,” she says. Another year: If you don't deliver on the study, you have to give your up-front money back to the sponsor. It may sounds obvious, but it isn't.
After the second Site Solutions Summit, Pierre launched a mailing list for attendees. The approximately 143 people who regularly post to the listserv are collegial. “This week, someone asked: 'Does anyone have a job description for a compliance officer?' Because why not? Why the heck not? If your biggest competitive edge is over the forms you create, then something's wrong,” she says.
Pierre continues, “A site might post a message querying, 'I wanted to get paid for audits—is that reasonable?' Then someone will say: 'We always put it in there.' There's a big discussion going on on there now about SOPs, and which ones do we need to have? And when anything new comes out of the FDA, I put it on there. It's a lot of advice and info sharing.”
Cost? There is none. Attendees just pay to come to the meeting. All the other stuff—the access to the listserv and metrics—is free.
After the second meeting, Pierre began publishing a position paper on the metrics she'd gathered, then traveling around and speaking about it all year at conferences. “Our goal is to disseminate information—not hoard it. We want everyone to talk about the info we've gathered and change for the better.”
In year three, Pierre began inviting sponsors to attend the Summit. Pretty soon that led to another idea: publicly recognizing the most site-friendly sponsors and contract research organizations (CROs). So before the meeting last fall, Pierre asked sites which sponsors and CROs scored best when it came to professionalism, preparedness and payments, among other measures. Then she got a statistician and validated the answers. At a dinner during the Summit, Quintiles and GlaxoSmithKline took home the top honors, embodied in trophies. Pierre plans to do that every year now, with the caveat that a sponsor or CRO must be present to win. “Otherwise, if you're not there, how committed are you to the site relationship?” Pierre quips.
Last year, the Summit had 220 attendees representing 108 sites and about 30 sponsors. Pretty soon, Pierre says she's going to cap the number in order to preserve intimacy. The cap will likely be 350 people. The next meeting is again in Clearwater, in mid-October.
Yes, there are other meetings that are site-centric, organized by the Association of Clinical Research Professionals and Drug Information Association (DIA), among other organizations. But Pierre says hers is the only conference that requires that attendees be serious stakeholders from sites: investigators, site owners or CEOs. “There are no other meetings that are for sites as a business,” Pierre asserts.
—by Suz Redfearnd9A2t49mkex