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Regulatory submissions will require supporting evidence of content validity of primary or key secondary endpoints.

Insights will be sought on clinical parameters not measured in a trial (such as the onset of action or duration of therapy).

The natural history of the disease is poorly known or not well-described in the literature.

The qualitative data gathered via patient interviews can be valuable in any therapeutic area but are particularly useful in studies of rare diseases, chronic diseases, and surgical interventions. When patient interviews are important to clinical trials

Patient interviews can be performed during the initial screening interview, be part of scheduled assessments during the trial, or conducted as exit interviews at the end of the trial. They can be conducted in person, by phone, via video conference, at the trial site, or in the patient's home. Interviews with patients in clinical trials are one-on-one, semi-structured interviews conducted with patients or caregivers to better understand, characterise, and document the impact of a disease, potential therapy, or a clinical program from a patient's perspective. The trial participant is, of course, the only direct source of experience with the investigational product before approval. These may, for instance, speak to ways to improve patient engagement during future trials and the patient's propensity to continue treatment or recommend it to another patient. After all, physiological measures and biomarkers donвЂ™t detect changes in patients' perceptions of their overall health, nor can they explain why treatment benefits are meaningful.ДЄnd finally, interviews with patients can enhance value communications with direct quotes, specific narratives, and a broad assessment of the trial experience. Patient interviews can further explain the evidence generated at a more operational level and shed light on the significance of specific quantitative outcomes вЂ“ insights of interest to regulators, HTAs, and payers. Patient interviews also help in refining the conceptual model of the study and support the development of patient assessments that are appropriate and valid. In the planning stages, they provide insight into the natural history of a disease, the burden of illness, and concepts of interest related to a condition вЂ“ all of which inform the research strategy and ensure that it will serve patients' needs. Patient interviews can be used to further the goals of patient centricity on multiple levels. Essential knowledge gained in patient interviews Interviewing patients in clinical trials is a valid approach to understanding the patient perspective of a disease or treatment, providing context for explaining and interpreting quantitative clinical data, and informing future outcome assessment strategies and trials.

What better way to do this than via direct interaction with patients to elicit their thoughts and experiences? Second, qualitative research methodologies have matured. Indeed, regulatory bodies and health technology assessment (HTA) bodies encourage companies to understand what is important to patients in clinical studies and disease treatment. First, the life sciences industry is committed to taking a patient-centric view of clinical development. Qualitative research is important in clinical development this is true for two reasons. Interviewing patients in clinical trials is an opportunity to let the patient voice be heard.

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