Benefit-Risk Evaluation


What is Ethnography?

Ethnography is a qualitative research methodology consisting of observing the practices and behaviors of individuals in their environment. It provides a unique opportunity to observe what people actually do which may vary from what they say they do. This methodology complements other qualitative research such as focus groups and in-depth interviews with stakeholders.

ParagonRx applies this methodology to healthcare by shadowing and observing clinicians in their practice as they interact with patients.

When would I need to conduct Ethnography?

Ethnography uncovers what truly goes on in clinical practice such as:
  • How patients are managed and the flow of activities
  • How clinicians interact with patients
  • How risks are managed
  • How existing risk management programs have been successfully (or not successfully) implemented
Because it provides deep insights into patient care, ethnography is recommended as part of an overall risk assessment and risk management planning to inform or confirm:
  • The current patient care process and how the new product will be integrated in clinical practice
  • Existing processes and/or tools currently used in clinical practice to manage risks
  • Gaps in the current care process that will expose patients to the risks of the new product and the supporting tools and/or materials that will be needed to mitigate the risks
  • Elements of a risk management program will fit in clinical practice

What are the benefits of conducting Ethnography?

Incorporating ethnography as an integral component of a product’s risk assessment and risk management planning provides real world insights into the current care process and reveals what healthcare professionals actually do when they manage their patients. A depiction of the flow of activities observed in clinical practice can be developed from the ethnography findings (See Care Process Mapping). These findings inform potential gaps in the current care process and allow for the design and development of risk mitigation tools and materials that are likely to be well accepted and integrated in clinical practice.

What makes ParagonRx Ethnography unique?

ParagonRx has extensive experience in conducting ethnography in the healthcare setting. We deploy our own healthcare professionals and scientists who are well-versed in the therapeutic area and possess a unique set of skills to ensure that their visit is conducted in a manner that is non-intrusive to the practice and conducive to stimulating discussions with clinicians. These skills combined with an extensive risk management experience provide clients with rich insights that are essential to the successful design and development of risk management programs. ParagonRx has conducted ethnography in numerous therapeutic areas with a variety of physician specialties.