PURPOSE: Conducting embedded interviews within clinical trials is a new research paradigm that can provide a variety of benefits, including understanding treatment benefit and safety/tolerability from the patient perspective, and estimating thresholds for meaningful change. Using a mixed method approach, embedded interview data can enrich our understanding of the patients’ experience to illuminate and complement the PRO and biomedical outcomes collected in the trial. This workshop will illustrate how embedded interviews can be utilized to generate in-depth and meaningful patient input through the drug development process.

DESCRIPTION:

After a brief introduction of the purpose of this type of research and value for different stakeholders, the speakers will present examples of embedded interview use within clinical trials and address resulting contributions to drug development research in each case study.

• (10 minutes) Introduction to description, uses and value of mixed methods embedded interview research to stakeholders. (Miriam Kimel)
• (10 minutes) Overview of value-added contributions of mixed method embedded interviews to support regulatory inquiries. (Naomi Knoble)
• (10 minutes) Case study on use of mixed methods assessment of patient treatment experience, including disease changes and tolerability in oncology. (Laurie Eliason)
• (10 minutes) Case study on use of longitudinal mixed methods approach to assess treatment benefit-risk assessment in a rare disease. (Carla Dias Barbosa)

Audience Interactive element

• (20 minutes) SMALL GROUP DISCUSSION

The audience will be invited to further the knowledge gained by developing a list of potential applications for embedded interview research through the drug develop process, with stated objective(s) and possible challenges for each example.

At the end of the workshop, participants will be able to:

• Identify at potential benefits that might be realized from incorporating a mixed methods design within their clinical trials
• Identify key challenges to embedding qualitative interviews into clinical trials
• Describe methods for meeting these challenges