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

Defining value in health care; thoughts on the 20th Annual European ISPOR Congress

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a global scientific and educational organization for health economics and outcomes research. The team at Sanofi recently attended the 20th Annual European Congress to present and discuss research findings.The congress was themed “the evolution of value in health care”; a timely reminder that definitions of value are changing, and an endorsement of the increasing role of patient organisations and representatives in defining value. This change is welcome and shows a progression often lacking in drug development research. However, the question of whether a clear and consistent definition of value can be provided and empirically supported remains open. Indeed it was apparent from presentations and discussions at the congress that some seek to embrace heterogeneity, while others seek simplicity and consistency.  It is likely that in the future public and private organisations will come together to provide some clear guidance on defining value, outlining whose perspectives to embrace and when. Although the totality of this guidance remains unknown, it is clear that the patient perspective will be central to this.In order to support this, the Clinical Outcome Assessment community at ISPOR and elsewhere need to think “bigger” than traditional quantitative outcomes. We need to embrace ways of engaging patients to understand experiences and perspectives beyond traditional endpoints. This will help ensure that we develop technologies to improve people’s lives, not just their health. The Sanofi team look forward to helping shape this movement.

15-Nov-2017 15:45 Read more

Expansion of the Clinical Outcomes Team at Sanofi

The Clinical outcomes team at Sanofi, which advises on the conceptualisation, utilisation, development, analysis, translation, and interpretation of patient-reported outcomes and other clinical outcome assessments, has recently welcomed two new members to the team. The team is now represented in two US locations, and three European locations.Both new team members are extremely experienced PRO Scientists who have a good understanding of the scientific principles that underpin subjective assessment, and have been involved in numerous pre-competitive research projects and collaborations to ensure interpretable capture of patient experience and patient outcome measures.

15-Nov-2017 15:40 Read more

The FDA Patient Engagement Advisory Committee (PEAC) meeting on Patient Engagement in Medical Device Clinical Trials

The Patient Engagement Advisory Committee (PEAC) to the US Food and Drug Administration (FDA) met on October 11-12, 2017 in Silver Springs, MD to discuss and make recommendations on patient input into clinical trials, with a specific focus on medical devices, despite being also relevant to drug development. The discussion topics included patient involvement in the design of clinical trials, patient recruitment, enrollment, retention and the communication of study results to trial participants.Round table discussions with members of the FDA and the audience including industry, patients/patient representatives and research organizations took place to discuss patient involvement in clinical trials, recruitment, enrollment, retention, and dissemination of study results to trial participants and other patients. FDA representatives summarized the discussions at the end of each roundtable discussion.Over the course of two days there were 16 open public hearing speakers that presented and provided comments to FDA. Speakers included patients, research organizations, industry, patient advocacy groups and other members of the public.Key takeaways from the meeting included the importance of getting patient input into all aspects of medical device [drug] development and to consider patients as the end users of these devices [drugs], the importance of measuring patient-centric PROs (patient-reported outcomes that matter to the patient), and applying patient-centered solutions to patient-centered problems/questions regarding unmet needs, benefits and risks. Applying such strategies will bring products that matter to patients to market faster, and help to identify earlier in the development process products with higher risks to patients than benefits. The meeting summary and presentations can be found on the PEAC meeting page.

30-Oct-2017 09:47 Read more