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ORIGINAL RESEARCH article

Front. Psychiatry
Sec. Schizophrenia
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1377174

Using Qualitative Exit Interviews to Explore Schizophrenia Burden and Treatment Experience in Clinical Trial Patients

Provisionally accepted
Adam Simmons Adam Simmons 1David McDonnell David McDonnell 1,2*Amy K. O'Sullivan Amy K. O'Sullivan 1Julia Carpenter-Conlin Julia Carpenter-Conlin 1Michelle K. Carty Michelle K. Carty 3Cory Saucier Cory Saucier 3
  • 1 Alkermes Inc, Waltham, Massachusetts, United States
  • 2 Alkermes Pharma Ireland Limited, Dublin, Ireland
  • 3 QualityMetric, LLC, Johnston, RI, United States

The final, formatted version of the article will be published soon.

    Evaluation of the efficacy and safety of investigational pharmacologic treatments for schizophrenia generally involves the use of well-known and validated quantitative measurement scales and clinician assessments. In 2022, the US Food and Drug Administration provided a final guidance to drug developers encouraging the collection of patient experience data related to the burden of disease and burden of treatment. In that guidance, the use of qualitative research methods was recommended as one way in which these data may be obtained. This report describes a novel approach to the integration of qualitative research into an open-label phase 3 clinical trial. In addition, patient perspectives of the symptoms of schizophrenia and their impact, coping mechanisms used to deal with the illness, past treatment experiences, unmet treatment needs, and patient perspectives about the experience of treatment with a study medication that was in development (at the time of the interview) were obtained using the patient's own voice.

    Keywords: antipsychotic medication, Content Analysis, Drug Development, exit interview, patient experience, Thematic analysis

    Received: 26 Jan 2024; Accepted: 31 Jul 2024.

    Copyright: © 2024 Simmons, McDonnell, O'Sullivan, Carpenter-Conlin, Carty and Saucier. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: David McDonnell, Alkermes Inc, Waltham, 02451, Massachusetts, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.