INC Research Holdings, Inc., a leading global phase I to IV contract research organization, announced the launch of the industry’s first Site Advocacy Group (SAG) devoted to the scientific and operational aspects of clinical research.
The SAG initially will focus on central nervous system (CNS) protocols – recognized as among the more complex therapeutic areas in clinical research – targeting psychiatry studies including, but not limited to, those in schizophrenia, attention-deficit/hyperactivity disorder (ADHD), depression and bipolar disorder.
“Through this forum, INC Research will collaborate with clinical research sites that have direct experience in psychiatry studies to gain their insights into the most common challenges and operational efficiencies that can be implemented for future studies,” said Clare Grace, vice president, Site and Patient Access. “We will leverage these expert insights to incorporate the site and patient voice in the evaluation of psychiatry study protocols for scientific merit and operational success. Ultimately, we expect our Site Advocacy Group to embed efficiencies in the planning phase and increase the quality and speed of these clinical trials for our customers.”
A recent 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 per cent longer to develop than other drugs. Progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.
“Creating this SAG underscores INC Research’s commitment to better leveraging the expertise of clinical research sites worldwide in developing treatments for important health conditions,” said Michael Gibertini, Ph.D., president, Clinical Development. “Engaging with sites early on and in a meaningful way is critical to enhancing protocol design and study conduct. Our focus is on driving improved collaborations and innovative approaches to connecting more effectively with sites across all therapeutic areas as we work together to deliver on our ultimate goal of bringing new medicines to market for patients in need.”
Members of INC Research’s scientific and operational SAG specialize in psychiatry, with at least 10 years’ experience in schizophrenia, ADHD, depression and/or bipolar disorder, and have five years’ experience as a principal investigator. The group will be involved on an ongoing basis in reviewing protocols and providing feedback and solutions to enhance the conduct of psychiatry studies. The launch of INC’s SAG included a recent face-to-face meeting at the Company’s Austin, Texas, location, which serves as a primary hub for its CNS clinical trials work.
“It’s exciting to be part of this groundbreaking collaboration to improve how we as an industry conduct clinical trials,” noted Andrew Cutler, M.D., chief executive officer and chief medical officer, Florida Clinical Research Center, LLC, and a member of the SAG. “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. Sites bring an important voice to help contribute to the clinical research process and ultimately improve it, to ensure trials are executed in the safest and most efficient way possible and newer, better medicines are ultimately developed for the patients who need them.”