As the only ones with firsthand experience of living with the disease day to day, patients bring irreplaceable perspectives to drug development that cannot be provided by any of the scientific, regulatory, or clinical experts. During the whole lifecycle of medicine development, practical consideration and inclusion of the patient's perspective in clinical trials will increase the quality of the development program. This can help to understand better/design the following areas:

• The clinical context for medicines development and product evaluation
• Product design features, including formulation and delivery modes that minimize burden and support adherence
• Development of endpoints that reflect benefits that matter most to patients and which adverse event endpoints are most important for patients
• Design trials that support better enrollment and retention and ensure a diversity of participants recruited to be reflective of the target population

However, we understand that, at the moment, strategies and methodologies to obtain patients' perspectives on a clinical trial are highly non-standardized. Significant regulatory authorities like ICH and FDA are developing guidelines to standardize the collection of patient feedback in clinical trial design. Therefore, we developed our internal methodology that considers the following essential features:

• includes patients and caregivers as partners to obtain optimal information (including patient advocacy groups)
• collecting data that are representative, valid, and reliable to assure proper planning and decision making
• gather information in a sustainable and timely manner
• Considers possible heterogeneity/subgroups

Also, information about patients' perspectives is gathered through different publicly available sources, including, e.g. Patient-Focused Drug Development (PFDD) Public Meetings-initiative facilitated by FDA focused on how to understand better patient's view of the most significant symptoms of their disease and treatments.