In partnership with Myovant Sciences, Martha Gauthier and Brooke Witherspoon of Lumanity’s Patient-Centered Outcomes group recently authored a manuscript characterizing the experience of living with endometriosis from a patient perspective.

The study leveraged exit interviews with participants in Myovant’s SPIRIT 1 and SPIRIT 2 (Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain) Phase III clinical trials to explore their experience with endometriosis. In addition to providing feedback related to clinical outcomes assessments (COAs) used in the trial to evaluate key endpoints, clinical trial participants shared their experiences with the signs, symptoms and impacts of endometriosis. These exit interviews were highly impactful in that they helped address questions related to the COA strategy and fill a gap in patient-based literature about the impact of endometriosis on women living with the condition.

Interviews in a Clinical Trial Setting

Exit interviews are a type of clinical trial-embedded interview (which may also include entry or interim interviews) that provide a unique opportunity to engage with trial participants to collect feedback on (but not limited to) diagnostic journey, disease burden, trial experience, meaningfulness of changes in health status, and COAs administered in the trial.

  • Entry interviews are ideal for characterizing disease burden at baseline, prior to treatment
  • Interim interviews can help sponsors understand what is happening to patients during the treatment period and why some elected to discontinue treatment
  • Exit interviews help uncover what happened to patients that may not have been captured by the pre-specified clinical trial measurement strategy, if the changes they experienced were meaningful to them and how they may have translated to impacts on their daily lives

Click the button below to access the manuscript on PubMed

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