The SAG will look to leverage the insights of clinical research sites and its own experts in CNS trials to incorporate the site and patient voice in the evaluation of psychiatry study protocols. One of the primary goals will be to develop protocols that are easier to operationalize and easier to enroll patients into.
The creation of the SAG for CNS studies comes as a previous study by the Tufts Center for the Study of Drug Development found that drugs to treat CNS diseases, such as epilepsy, Alzheimer’s, autism, schizophrenia and depression take 35% longer to develop than other drugs. In certain studies, progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.
“The protocol review SAG plays a huge role in improving the experience for sites. Having input from experienced sites into protocols much earlier on enables us to develop protocols that are much more realistic and easy, not only to conduct and operationalize, but much easier for the patients, too,” Clare Grace, VP of site and patient access, told Outsourcing-Pharma.com.
INC also is collaborating with the Society for Clinical Research Sites to develop a protocol review SAG.
“In the long term, we’d like to expand the use of our site advocacy groups. We’d like to look at different therapeutic areas that can benefit from using input from different groups of sites to design better protocols,” Grace added. “We’d also like to look at other areas that are that particularly challenging for sites like investigator payments, which we know is a real challenge in the industry. Through our site advocacy groups, we hope to better support our development of new processes, new systems and new tools to continue to innovate for the industry.”
She also noted that so far, clients have been receptive to the idea of the SAG, and ultimately the goal is to adapt the pilot program for the SAG model to all trials run by INC. The launch of the SAG included a recent face-to-face meeting at the company’s Austin, Texas-based site, which serves as a primary hub for its CNS clinical trials work.
Andrew Cutler, CEO and Chief Medical Officer of Florida Clinical Research Center, a member of the SAG, added: “When I look at studies that have been successful, a common theme among them is a strong connection and communication among sites, CROs and sponsors, and the Site Advocacy Group is a great forum to facilitate this collaboration.”