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

The 5th Winter Symposium of the Human Motion Project

On March 7th 2018, Sanofi’s PRO Team attended the 5th Winter Symposium of the Human Motion Project. The vision of the project is to improve human health by an open collaborative technology platform for the mobile medical monitoring of human motion. The 2018 symposium focused on novel endpoints generated by mobile accelerometry for use in clinical trials. PRO research has highlighted the significance of reduced physical capacity to patients with chronic illness. Accelerometry is a technique for objectively quantifying movement patterns during walking and has more applicability in the real world compared to more traditional gait analysis or laboratory-based testing environment. However, its use in clinical trials has been restricted by questions around its sensitivity, specificity, precision and algorithms for analysis, as well as a lack of standardization of endpoints. The 5th Winter Symposium of the Human Motion Project included presentations and discussions focused on these topics. Specific topics included defining standards in accelerometer implementation and endpoints, testing of new algorithms for step detection and speed estimation, and linking accelerometer data to hard morbidity and mortality outcomes.This is an important area for the future of clinical research and we are excited about developments allowing for more mainstream use and consistency in specification and interpretation.

12-Mar-2018 14:15 Read more

Sanofi at the 59th ASH Annual Meeting and Exposition

On Dec 9-11, 2017, a member of Sanofi’s Department of Clinical Outcomes (CO) Team attended the 59th American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta, GA, USA. It was a great opportunity to gather information on hematological treatments and methodological advances in the hematology field; particularly hematological malignancies including multiple myeloma.There were multiple presentations on patient perspectives, symptom experiences, health-related quality of life, financial burden, health economic models, resource utilization, costs, development of PROs, cost-effectiveness of treatment and economic burden of disease. Sanofi’s PRO Strategy for three Isatuximab studies were also discussed and presented at the meeting (ICARIA,IKEMA and IMROZ, NCT02990338, NCT03275285 and NCT03319667). In addition, the meeting provided information about cutting edge technology regarding treatment advances and measurement of the endpoints that matter to patients, providers, payers and employers; for example wearable devices to assess impact on and improvements in mobility and functionality due to disease and treatment.The insights gained during this meeting will help us to develop clinical outcome, publication and reimbursement strategies at Sanofi.

08-Jan-2018 13:41 Read more

Presenting at an FDA-CERSI workshop on advancing the use of patient preference information as scientific evidence – some reflections

In December 2017, a collaborative workshop was hosted by the Centers of Excellence in Regulatory Science and Innovation (CERSIs) and the Food and Drug Administration (FDA) titled “Advancing Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation”. The workshop aimed to discuss the current regulatory landscape for the collection, analysis, interpretation and presentation of patient preference information (PPI) and identify future research and capacity needs in order to improve the use of PPI in a regulatory context.Plentiful research highlights that patients have unique perspectives about the value of the potential benefits and the impact of potential harms and burdens of their medical treatments. The consideration of patients’ needs, values and preferences is one of the core principles of evidence-based medicine, but reliable and accurate methods are needed in order to effectively incorporate these into the benefit-risk appraisal of a new technology. PPI is qualitative input or quantitative data elicited from patients to provide estimates of how much different outcomes, endpoints or other attributes are valued by patients, and the trade-offs that patients state or demonstrate they are willing to make among them.The workshop focused primarily on eliciting PPI through stated preference methods - in which preferences are elicited by offering choices or posing contingent valuation questions to study participants - and revealed-preference methods in which patient preferences are obtained from the actual observed choices made by patients. Little discussion focused on qualitative data or data derived from quantitative patient-reported outcome instruments.Matt Reaney from the Sanofi PRO team was invited to provide an industry perspective on eliciting and utilising PPI. Matt welcomed the discussion of PPI and its potential use in individual decision-making. He noted that industry regularly conducts research to elicit PPI in order to develop target product profiles and probability of success documents, inform unmet need and disease burden, make investment decisions, and define what constitutes a meaningful benefit. However, Matt did identify some challenges in generating robust data specifically for regulatory decision-making, namely: The reliance of many methods on hypothetical scenarios The heterogeneity between and within patients over time The potential differences between contexts e.g. when there are no other treatments available, compared when safe and efficacious treatments are already approved The role of experience on preference framing Potential differences in preferences for initiating therapy and preferences for continuing therapy In addition, there are some institutional challenges in generating PPI for regulators. For example, different methods may be utilised to answer different questions and qualitative research, stated or revealed preference studies, cross-over trial design, and PROs have traditionally been managed by separate domains in the industry. In order for the right method to be selected based on the question asked, knowledge of all “preference methods” would be required within a single function. External guidance documents outlining the utility of PPI data in principle, and the research requirements and evidentiary standards to inform the role of PPI in decision-making would assist in the provision of such a function. Matt’s comments were included in a media piece for Biocentury.We hope that this workshop was the beginning of meaningful collaboration between patients, regulators, academics and industry in identifying how to make use of PPI in regulatory decision making – something which is important to all.

08-Jan-2018 13:37 Read more