IMPLEMENTATION OF EMBEDDED QUALITATIVE INTERVIEWS IN CLINICAL TRIALS: INSIGHTS FROM THE LITERATURE
Author(s)
Jaymin Patel1, Khang Nguyen, PharmD2, Denise Garner, BA, PharmD2, Danny Yeh, PhD3;
1AESARA, Associate Director - HEOR, Wake Forest, NC, USA, 2AESARA, Chapel Hill, NC, USA, 3Aesara, Burlingame, CA, USA
1AESARA, Associate Director - HEOR, Wake Forest, NC, USA, 2AESARA, Chapel Hill, NC, USA, 3Aesara, Burlingame, CA, USA
OBJECTIVES: Patient experience data are central to regulatory decision making under Patient Focused Drug Development guidance. Qualitative interviews embedded in clinical trials can reveal benefits beyond conventional clinical outcome assessments, yet public sources offer limited detail on implementation. This study characterized current approaches to embedded qualitative interviews in trials.
METHODS: We searched PubMed and Embase for reports published from 2016 through 2025 that included results from qualitative interviews conducted within clinical trials. For each study we extracted therapeutic area, interview intent, timing within the trial, language, site selection approach, and reported limitations and operational challenges.
RESULTS: Thirty two studies met inclusion criteria; twenty six were published from 2021 to 2025 and six from 2016 to 2020. Only 41% of the studies disclosed inclusion of qualitative interviews in protocols uploaded to ClinicalTrials.gov. Embedded interviews were most common in oncology (34%) and rare diseases (41%) and were frequently conducted in phase 3 studies (59%). Most interviews explored perceived treatment benefit (84%) and were implemented as exit interviews at or near study completion (66%). Interviews were often limited to a subset of trial sites (81%) and conducted in participants’ native languages. Variability in operational approaches and reporting practices highlighted challenges related to representativeness, recall bias, maintenance of blinding, and generalizability.
CONCLUSIONS: Embedded qualitative interviews provide unique insights from patient experience data, and their use has expanded in recent years. Broader and more consistent implementation would benefit from clearer documentation standards, pre-specification of sampling and timing, and practical guidance to mitigate biases and site level variability. These steps can strengthen interpretability and inform decision making.
METHODS: We searched PubMed and Embase for reports published from 2016 through 2025 that included results from qualitative interviews conducted within clinical trials. For each study we extracted therapeutic area, interview intent, timing within the trial, language, site selection approach, and reported limitations and operational challenges.
RESULTS: Thirty two studies met inclusion criteria; twenty six were published from 2021 to 2025 and six from 2016 to 2020. Only 41% of the studies disclosed inclusion of qualitative interviews in protocols uploaded to ClinicalTrials.gov. Embedded interviews were most common in oncology (34%) and rare diseases (41%) and were frequently conducted in phase 3 studies (59%). Most interviews explored perceived treatment benefit (84%) and were implemented as exit interviews at or near study completion (66%). Interviews were often limited to a subset of trial sites (81%) and conducted in participants’ native languages. Variability in operational approaches and reporting practices highlighted challenges related to representativeness, recall bias, maintenance of blinding, and generalizability.
CONCLUSIONS: Embedded qualitative interviews provide unique insights from patient experience data, and their use has expanded in recent years. Broader and more consistent implementation would benefit from clearer documentation standards, pre-specification of sampling and timing, and practical guidance to mitigate biases and site level variability. These steps can strengthen interpretability and inform decision making.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR204
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas