This web-based, educational, platform was developed by the Sjögren’s Foundation to train investigators involved with clinical trials in Sjögren’s. This platform can be used by biotechnology and pharmaceutical companies seeking standardized training for clinical trials, by investigators and their staff who participate in multi-center trials, and/or clinical research organization associates who monitor the correct use of Sjögren’s indices.
Each company who subscribes to STEP will be given a company specific portal which is password-protected and can be customized to include study-specific information. In addition, each company may decide which domains will be covered, how many questions on a specific domain will be included, add questions and personalize their site per the needs of their study. Questions on each ESSDAI domain are offered so that users become familiar with the domain, and, at the end of the test, complex clinical scenarios that mimic real patients are offered so that users practice how to determine multiple domains to be scored in one patient and then how to total ESSDAI scores. Users have the opportunity to review the ESSDAI training materials available on the site before and during the exam and to print the available resources for review and/or future reference in the clinic.
Co-chairing this effort were Dr. Theresa Lawrence Ford (private practice clinician and clinical trial center coordinator) and Dr. Raphaèle Seror (Université Paris Sud, France), along with support and guidance from our ESSDAI-ESSPRI Online Training Advisory Committee, appointed by the Foundation’s Clinical Trials Consortium Steering Committee. Drs. Lawrence Ford and Seror, along with Kathy Hammitt, Sjögren’s Foundation Vice President of Medical & Scientific Affairs, serve as program advisors responsible for ongoing program development, content accuracy, updated testing, and oversight.
If your company would like to subscribe or learn more about using STEP, please contact khammitt [at] sjogrens [dot] org