Team Supports International Sites
The AIDS Clinical Trials Group (ACTG) Network boasts 60 Clinical Research Sites (CRS) around the world. A seven-person team stands at the ready to support these sites with opening studies, negotiating regulatory requirements, tracking site capabilities and orientating new sites. The team makes up the Network’s Site Coordination Group and is based at the ACTG’s Network Coordinating Center (NCC) at Social & Scientific Systems in Silver Spring, Maryland. They are overseen by the ACTG’s International Vice Chair Dr. Ian Sanne, FCP, FRCP, Principal Investigator of the ACTG’s University of Witwatersrand Clinical Trials Unit in Johannesburg, South Africa. Team members include Christina Harris, PhD; Nefertari Johnson, MS; Stephanie Holland, BS; Emily Sunwoo, BS; Allegra Cermak, MFA; and Akbar Shahkolahi, PhD. Shahkolahi serves as the team’s Group Manager.
“Coordinating the Network’s sites is an ongoing effort focused initially on Division of AIDS (DAIDS) site activation and then protocol activation,” says Sanne. “The interaction with the NCC team facilitates the support for site capacity, regulatory, laboratory and pharmacy. The team does an outstanding job of bringing all the components together.”
All US and non-US CRSs have daily support available to them through the NCC Site Specialists. Shahkolahi, Harris, and Johnson are the team’s Site Specialists, each responsible for supporting a number of US and non-US sites. Site Specialists hold regular site calls and perform site visits with the sponsor and Network leadership. They triage site needs; liaise between sites, DAIDS, ACTG Lab group and the Network leadership; and troubleshoot issues. ACTG Site Specialists also work with protocol teams to keep them up-to-date on site issues and status toward study participation.
“Site Specialists are problem solvers,” says Shahkolahi. “They stay current on sites’ needs and address any issues, including those related to regulatory challenges, shipping, drug procurement, study records, and an array of issues pertaining to their Network participation.”
Johnson says one of the best parts of her job is solving problems in person.
“Conducting in-country site visits provides the site specialist with an opportunity to engage and interact with clinical research site staff in real time, thus allowing issues to be resolved with less delay. I recall a site visit to Kenya in which three different CRSs were visited in one trip. Each site was addressing concerns that were specific to their CRS or region. The NCC Site Group was able to visit each site independently and provide training and in-person support to collaboratively resolve each site’s issues. As a result of the on-site support CRSs feel comfortable asking the Site Group for assistance, as they know we will work diligently to help them resolve any problems that may arise.”
One effort to make that process easier has been the development of a system for capturing the capabilities at each ACTG site including special skills, clinics and staff experience. Shahkolahi’s team designed a system for tracking sites’ capabilities. And as part of that process, the team reviews protocol complexity with internal and external NCC team members to identify complex protocols and programmers to create systems that meet NCC’s tracking needs. This system gives everyone an early heads-up that sites involved in a protocol may require special staffing expertise, site/lab/equipment needs, or expected recruitment difficulties. The team is also working on developing an interactive system tracking database in the MIS to access International Sites regulatory (IRB) submission and its progress real time. The database will complement the system used for tracking and identifying sites protocols progress at its early stages of its implementation.
Keeping the team in action are Holland and Sunwoo, who arrange, support and keep track of the many calls and communications necessary for the international team to update records and summaries. Conference calls with sites include not only the ACTG NCC team and the site, but also participants from the Division of AIDS (DAIDS), the Statistical and Data Analysis Center (SDAC), Frontier Science & Technology Research Foundation (FSTRF), protocol team members, and additional participants as needed. Each ACTG site has a Community Advisory Board or CAB made up of people infected or affected by HIV. These community volunteers assist a site with outreach and educational efforts as well as provide site staff with feedback on the feasibility of studies. Each site chooses a representative from their local CAB to serve on the Network-wide Global Community Advisory Board or GCAB. Holland and Sunwoo support the GCAB and other community calls for which most non-US participants are dialed in – very busy calls indeed.
The ACTG’s CABs are supported by Cermak. The CAB committees, like other ACTG committees, receive support for calls and meetings. The ACTG CAB has its own newsletter, educational requests and community efforts. They are supported in their participation with other community groups at DAIDS and in their local communities. Cermak also helps with any site questions and visits sites to provide training or assistance with CAB projects and concerns.
“I am motivated seeing what people at all the sites commit to this work and sharing their successes with the rest of the network,” Cermak says. “There are so many CAB members with diverse interests outside of the ACTG and that has created a stronger community with greater outreach. The community’s contributions have grown stronger every year and I think everyone now sees that it is integral to successful research.”
Pictured above from top left: Akbar Shahkolahi, Nefertari Johnson, Allegra Cermak, Stephanie Holland, Emily Sunwoo, and Christina Harris