Clinical research sites now have their first-ever trade group.
Launched this past weekend at the annual Site Solutions Summit, the Society for Clinical Research Sites (SCRS) is being spearheaded by Christine Pierre, founder and long-time president of Baltimore area-based site group RxTrials.
For decades, sites have been badly in need of a trade association to represent them, said Pierre.
“Other sectors of the drug-development industry have had their trade organizations representing them for years,” she said, pointing to the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents sponsors; the Biotechnology Industry Organization (BIO), which represents biotech companies; and the Association of Clinical Research Organizations (ACRO), which represents CROs.
As sites were left largely free floating and alone, they were excluded from important discussions that have shaped the drug development landscape, she said.
“Until now, sites have had to accept, embrace and execute whatever it is other organizations have decided,” said Pierre. “Sites need to be involved in the critical dialogues going on every day pertaining to the evolving practices of the conduct of clinical research. Sites need to be committed partners in the clinical research enterprise. The only way we’re going to do that is to consolidate as a sector of the industry and participate with the other stakeholders at policy and business practices discussions.”
The FDA agrees a hole existed.
“This is a very timely and exciting development,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said of the new group. “As we embrace the era of molecular medicine and look for ways to modernize the clinical trial enterprise, the voice of the clinical research site community is critical in the dialogue of how to more efficiently study promising drugs and get them to patients.”
The mission of SCRS, then, will be to unify and amplify the voice of the global clinical research community, said Pierre, who was president of the Association of Clinical Research Professionals (ACRP) in 2007.
Sites will make up the bulk of SCRS’ membership, but CROs, sponsors and suppliers can join as associate members.
“We recognize that it takes collaboration,” said Pierre, who will serve as president of the new group.
Clare Grace, PPD’s senior director of site and patient recruitment, is on the SCRS’ advisory board. She said her hope is that the new group helps CROs and sponsors to better understand sites, and vice versa.
“It’s important that we understand the needs and the thoughts of the site community, and this will be a useful way to help them understand us, too,” she said.
SCRS, said Pierre, grew out of the Site Solutions Summit, which she launched in 2006 for site owners, executives and investigators to gather and discuss best practices and whatever else was on their minds regarding work at the site level. The summit has grown each year, and from the first meeting, Pierre said, site leaders lamented the lack of a trade group to represent them at the table with sponsors and CROs.
Pierre said she’s been working on the nuts and bolts of the new trade association for about a year, hiring association management company Management Solutions Plus to help launch and run it. She’s also been amassing a leadership council with representatives from across the global research community representing academic sites, practice-based sites and site networks.
“The response has been unbelievable,” said Pierre. “People said, ‘It’s about time!’ Sites need this desperately. But also, industry needs the sites to have their own community, because the sites have largely been absent from the discussion. I don’t think sponsors and CROs try to exclude sites, but where do these organizations go when they say: we want to hear what sites think? There hasn’t been a central place. By default, the Site Solutions Summit had, in many ways, become a de facto trade association for sites.”
In fact, the Site Solutions Summit, held every October, will now serve as the venue for the new group’s annual meeting. SCRS members will meet during the Summit weekend.
The summit already is known for gathering information about the sites from the sites, through its annual survey, and then generating benchmarking data. SCRS, said Pierre, will take that further by amassing a database of sites that associate member CROs and sponsors can access to aid in their site selection. Sites will enter very detailed information about recent trials, therapeutic areas of focus, enrollments goals, randomization, FDA audits and outcome.
“We will have the only cross section on performance, enrollment and FDA audits,” said Pierre.
SCRS will launch a quarterly newsletter, called InSite. It will begin as a news organ for sites, but Pierre said she anticipates it morphing into a peer-reviewed journal for clinical research sites as SCRS gathers more data and publishes reports and studies on key dynamics in the site sector.
SCRS will have a public policy committee, but Pierre doesn’t anticipate lobbying on Capitol Hill. Rather, the group likely will join other industry groups in their lobbying efforts. Nor does Pierre anticipate getting into the accreditation world, but rather plans to endorse certain certification and accrediting bodies, generalized GCP training and education.
“While we put on the Site Solutions Summit, and we may have some courses we offer our members, we really see ourselves partnering with and endorsing other organizations that are doing a fabulous job,” she said.
The membership fee for an individual site—which allows all site employees to become members—is $997 per year. The annual fee for corporate site networks is $5,000, with an additional $295 for each of its affiliated sites. A nonprofit or government entity will pay $4,000, plus $250 for each additional site or department. Associate members (which include CROs, sponsors and suppliers) pay $997 if they have revenues under $50 million and $2,500 if their revenues are above $50 million.
Pierre said she’s eager for sites to tell her and the group’s leadership council what they hope their new trade organization will accomplish for them, both individually as sites and as a sector.
“We’re looking for the membership to help us define what would best suit their needs,” she said. “But we’ll start by, on their behalf, advocating, connecting, educating and mentoring.”