Abbreviated protocol - Study protocols are reviewed multiple times across their development; this is one particular subset of this ongoing work.
Capacity building program - Structured training programs delivered by experts external to Sanofi that are intended to help strengthen patient advocacy groups (PAGs) through classroom learning and practical application, peer-to-peer support and review of case studies, and academic understanding of effective governance structures.
Clinical trial endpoint - A clinical trial endpoint is a specific, measurable outcome that researchers define before the trial begins to answer the central question: “Did this treatment work?” It is the primary metric in the study, designed to evaluate the safety and efficacy of an investigational drug.
Digital and decentralized clinical trial (DCT) - A DCT is a digital and decentralized clinical trial. By using telehealth, home healthcare, e-Consent, and wearable devices, DCTs expand patient access and provide convenience.
Integrated evidence generation plan - The integrated evidence generation plan is our internal roadmap and plan for gathering data throughout the life cycle of a product.
Patient experience data (PED) - Patients have the full day-to-day experience of their medical condition. They experience the daily ups and downs of their medical care and how the condition impacts their everyday life. Patient experience data is the term used to describe evidence which captures all of these experiences. Healthcare research can use this evidence to design better ways of managing a person’s condition and providing the most appropriate care. Learn more here.
Patient relevant drug label strategy - This means we seek labels that include data patients have indicated as important to them.
Real-world data (RWD) - Real-world data is data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. Learn more here.
Scientific exchange - Scientific exchange refers to joint discussions between clinical research or medical staff and patient advocacy group (PAG) leaders on scientific topics of mutual interest to Sanofi and the patient community. This can include review of recent product publications, pipeline developments, and clinical trial progress.
Structured benefit-risk assessment (sBRA) - An sBRA is a systematic evaluation of the positive therapeutic effects of a drug against its potential adverse effects, safety and other elements of patient preference.
