PURPOSE:

The purpose of this workshop is to discuss operational considerations for conducting robust and meaningful qualitative research aimed at understanding the patient experience related to disease and treatment burden in special populations. Special populations may include such groups as children, elderly, people with mental and/or physical disabilities, people nearing end-of-life, or people with rare disease.

DESCRIPTION:

There has been an increasing emphasis to take a patient-focused approach to medical product development and regulation. With this initiative (Patient-Focused Drug Development), there is a critical need to obtain patient input to identify what matters most to patients to be measured in clinical trials. Qualitative methods are one method to elicit patient input. However more information could be provided on how best to operationalize this method, especially in special populations.

The workshop will outline some suggested best practices from regulatory, research, and industry perspectives. The regulatory perspective will outline considerations for how stakeholders can collect relevant information from these populations in qualitative studies for medical product development and regulatory decision making. The research perspective will illuminate specific challenges related to these populations and provide exemplars of how best to overcome them. Examples include, the need to create a familiar environment to offset the novelty of the interview experience in pediatrics and ways to establish trust with the elderly or terminally ill patient who may feel isolated in their experience. Finally, the industry perspective will highlight internal facilitators and barriers associated with conducting qualitative research in special populations.

Discussion leaders will engage attendees to share their perspectives, as well as to provide insight gained from their own research, which may be helpful in informing planned regulatory guidances.