Pharmaceutical Product Development, LLC (PPD) has launched PPD’s SiteCoach, providing clinical research training, coaching and support to physicians, hospitals and academic institutions that are new to clinical research. SiteCoach aims to expand access to clinical trials and accelerate the development of life-changing medicines. By adding high-performing research sites and broadening the pool of patients potentially eligible for trials, the program is designed to address the industry challenge of site and patient access for pharmaceutical and biotech companies developing promising new therapies.
Approximately 50 percent of principal investigators who participate in a clinical trial for the first time do not participate again, citing complexity of trials as the main reason, according to the Tufts Center for the Study of Drug Development’s analysis of data from the U.S. Food and Drug Administration. By providing advanced training tailored to the needs of the investigative site and staff, PPD intends to enhance a new site’s probability of being successful in clinical research and to offer PPD customers access to additional sites that can participate in future studies. The ongoing training and support offered through SiteCoach is designed to encourage repeat site participation in trials.
SiteCoach includes appropriate tools and comprehensive training at each critical stage of the clinical trial process. Training is conducted between site qualification and activation, before the study, during the study and after the study to provide a full continuum of support. Training can be delivered virtually, face-to-face or combined, as needed. Features include a user-friendly online interface, a learner community portal offering resources and tools, a learner forum and mobile gaming designed to increase learner retention.
“This new model is an easy-to-use program for health care practices that are interested in joining the research community so as to offer their patients new treatment opportunities,” said Rhonda Henry, vice president of site collaboration and patient centricity for PPD. “Training more health care providers to conduct clinical research will give patients greater access to trials closer to home, making it more convenient for patients to participate. By placing more trials in the community, we also intend to enhance participation of patient populations traditionally underrepresented in clinical research.”
Jay Dixon, Senior Vice President of quality and enterprise learning at PPD, said, “Through our extensive experience in clinical trials and adult learning we are able to deliver effective training to new-to-research investigators. Our proven, award-winning training methods will help develop high-performing sites that provide quality data on multiple studies.”
The SiteCoach program is underpinned by PPD’s industry-recognized clinical research training program, which has been providing comprehensive coaching for more than 30 years. SiteCoach is part of the TransCelerate site qualification and training initiative, a mutual recognition program for ICH E6 good clinical practice training.
The pilot program for SiteCoach provided training to new-to-research investigators in remote areas of Thailand whose patients otherwise would not have benefitted from participation in a clinical trial. The enrollment rate for sites participating in the pilot was 70% higher, whereas screen failure rates and quality findings were almost 10% lower than other research sites in the study.
SiteCoach now is being adopted by several universities to increase student and faculty capabilities and success in research involving clinical trials. In early deliveries, survey results show 89% of trainees found the training to be a worthwhile investment and 100% of trainees reported they would be able to apply the knowledge and skills learned to their job. PPD is also partnering with Envision Research, a division of BRF, to train sites in rural Louisiana to enable physician practices to participate in clinical research, as well as offer their communities access to additional health care options.
Sites can register to participate in SiteCoach through PPD's website.