Sanofi PRO Questionnaires

Capturing the patient’s perspective through Patient-Reported Outcome questionnaires

Health is more than the absence of disease. It has physical, social and psychological components that can only be understood by asking and listening to those who have ill health and/or require medication. For more than 20 years, Sanofi has explored how diseases and medication impact patients’ daily life through the use of Patient-Reported Outcome (PRO) questionnaires. These questionnaires capture the perspective of those who are living with the disease on many topics of central importance for them, such as disease signs and symptoms, physical functioning, quality of life, satisfaction, or medication side-effects.

We have implemented many existing PRO questionnaires in our clinical programs over the years. When existing questionnaires were inadequate or concepts of importance to patients had not been previously evaluated, we developed new PRO questionnaires. These questionnaires were developed alongside patients in a scientifically rigorous manner to ensure robust and holistic evaluation of things that matter to them. This website presents the PRO questionnaires developed by Sanofi and those currently in development, to all who may be interested: pharmaceutical companies, academics, clinicians, and patients.

Our PRO Questionnaires


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PRO questionnaires

Latest News

Artificial Intelligence (AI) Health and Pharma Summit; 14th June 2018

The inaugural AI Health & Pharma Summit was held recently as part of London Tech Week. The one-day meeting bought together the key stakeholders in pharmaceutical drug development and healthcare to discuss how AI technology can enhance scientific research through better decision-making, optimized innovation, improved efficiency of clinical trials, and new tool creation for physicians, consumers, insurers, and regulators. The event attracted start-up and established AI companies as well as pharmaceutical research and development, medical and commercial participants. Case studies were presented on how AI has been used to expedite timelines, identify data gaps and inform precision drug targeting, streamline clinical trials, and enhance patient safety monitoring. Examples were also give on how AI can improve patient-physician communication, enhance note taking, and predict patient outcomes in routine practice.The use of AI for healthcare has been actively growing and we are excited about the role of AI data in the development of products and services to enhance patient care and patient-relevant outcomes.

02-Jul-2018 12:23 Read more

FDA releases draft patient-focused drug development (PFDD) guidance

In accordance with the 21st Century Cures Act, the US Food and Drug Administration (FDA) is developing a series of four methodological PFDD guidance documents to address how patient experience data and other relevant information from patients and caregivers can be systematically and robustly collected and submitted for consideration in the regulatory review of medical products. The first guidance (Guidance 1) was released in draft for public consultation on June 12th. This guidance discusses sampling methods that could be used when planning to collect patient input, providing a general overview of the relationship between potential research question(s) and method(s), management and analysis. The remaining guidances will propose specific methods to elicit detailed, unbiased, and comprehensive input from patients, patient groups, and caregivers (Guidance 2; draft in 2019), explore how patient input should be used in development of clinical outcomes assessment strategies (Guidance 3; draft in 2020) and in developing and interpreting patient-focused endpoints for clinical trials (Guidance 4; draft in 2020).The PRO team at Sanofi are excited about the increasing acknowledgement of patient experience in regulatory decision making as indicated by the development of these guidances. We hope that the FDA will be cognisant of the broad implementation challenges that have come from the stringent requirements in the FDAs PRO guidance from 2009 and will not impose similar restrictions on generating patient experience data.Detail about the PFDD guidance series is available here: draft of Guidance 1 is available here:

02-Jul-2018 12:21 Read more

Sanofi present at ISPOR 2018

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) held its 23rd Annual International Meeting in Baltimore in May. The conference, attracting nearly 4000 delegates from over 70 countries, was focused on real-world evidence, digital health, and the new landscape for health decision making. Patient perspectives on health, wellness, medication and healthcare was a central theme. Specifically, there were numerous discussions about the use of patient insights, experiences and preferences for defining outcomes (i.e. patient-defined value); collection of outcome data outside a trial to give confidence to the generalisability of trial data; and definitions of populations to allow for precision-medicine development/indication. It was encouraging to see so many patients and patient groups active in the ISPOR community, and the acknowledged important of such perspectives across all sessions. Matt Reaney from the Sanofi Clinical Outcomes Generation team was invited to present during one of the three plenary sessions focused on patient preference information in regulatory decision making. This session is summarised in a press release from ISPOR:

11-Jun-2018 10:57 Read more