HAS Real World Stidy Guide: https://www.has-sante.fr/upload/docs/application/pdf/2021-06/real-world_studies_for_the_assessment_of_medicinal_products_and_medical_devices.pdf

The Haute Autorité de Santé (HAS), France’s National Authority for Health, is responsible for scientifically evaluating medicinal products and medical devices in terms of their medical, economic, and public health value. While clinical trials have traditionally been the foundation for these assessments, HAS is increasingly incorporating “real-world data” (RWE) into their evaluations.

Real-world data comes from sources other than conventional clinical trials and includes observational data and data on the use, efficacy, and safety of health products. This kind of data is particularly useful because clinical trials often have limitations; their controlled conditions can differ significantly from real-life medical practice, and their results might not be applicable in all cases. For example, new therapies involving gene technologies or machine learning bring uncertainties that can only be fully understood in real-world conditions.

Real-world studies offer advantages like understanding a product’s performance in actual clinical settings, identifying the patients most likely to benefit, and foreseeing potential risks. They also allow for the inclusion of patient perspectives, which are becoming increasingly important in the evaluation process.

HAS has begun updating its methodological guide on real-world studies to provide practical guidelines for such evaluations. This is due to increased access to health data and the growing recognition of the importance of real-world data to complement clinical trials. These guidelines aim to aid all stakeholders involved in the health product evaluation process, including manufacturers, research companies, and academic teams, in the design and implementation of real-world studies.

In summary, HAS is expanding its reliance on real-world data to enhance the quality and applicability of its health product assessments. This shift is aimed at capturing a more comprehensive picture of product effectiveness and safety, which ultimately benefits patient care.