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Neuroscience

The Power of Qualitative Exit Interviews in Psychiatry Trials: Elevating the Patient Voice

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Qualitative exit interviews are emerging as a valuable addition to clinical trials for central nervous system (CNS) disorders like schizophrenia, offering crucial insights into patient and caregiver experiences for sponsors, regulators, and others involved in the development, approval, and commercialization of new treatments.  

While symptom scales and other quantitative tools remain essential, they can miss the nuanced and subjective aspects of treatment effect. This is where qualitative exit interviews excel, providing a more comprehensive, patient-centered view of the treatment journey. As their utility increases, qualitative methodologies are poised to play a larger role in the future of CNS clinical trials. 

Revealing the human impact of treatment beyond numbers 

Unlike quantitative scales, which focus on measuring symptoms and physical functioning, qualitative exit interviews capture the patient’s voice, providing deeper, more nuanced insights into the personal and social impact of a condition.i  

For example, in a recent study of 41 patients with schizophrenia, participants shared that living with this disorder affects much more than symptoms like hallucinations or paranoia.ii They described the toll it takes on relationships, self-esteem, and daily activities – areas often overlooked by quantitative tools such as the Positive and Negative Syndrome Scale. Through structured, open-ended interviews, this study found that patients reported improvements in emotional or mental well-being (63.4%), self-esteem (61.0%), social activity (61.0%), and daily functions, contributing to an overall sense of normalcy and engagement in life.ii 

Traditional quantitative assessments typically miss these aspects of emotional and social recovery, which are significant to both patients and caregivers. While quantitative measures might indicate a reduction in hallucinations, they do not capture the relief a patient feels in reclaiming confidence to attend social gatherings or engage in day-to-day routines. These findings emphasize the value of understanding improvements that matter most to patients and highlight quantitative assessment limitations. 

Overcoming challenges to derive deeper patient insights 

Conducting qualitative interviews with patients facing mental illnesses like schizophrenia can be challenging, yet their exclusion restricts the depth of insights clinical research can achieve. Critics suggest that patients with CNS disorders may have cognitive impairments or reduced self-awareness, casting doubt on their feedback’s reliability. However, the schizophrenia study highlighted above counters those concerns, demonstrating that such challenges can be overcome with a rigorous methodological approach and thorough interviewer training.ii  

Another concern is new adverse event (AE) reporting during qualitative interviews. Ensuring that AEs are flagged to the investigator and reconciled with clinical trial records is critical for maintaining regulatory compliance. The above schizophrenia study demonstrated that this can be achieved without compromising the integrity of the qualitative data.ii By embedding safeguards into the process, the potential drawbacks of qualitative interviews are mitigated and transformed into strengths that enhance the overall robustness of the trial. 

Incorporating qualitative exit interviews in clinical trials, therefore, goes beyond managing methodological obstacles. It enriches the drug development process by capturing patient-centered insights that can be pivotal in shaping regulatory decisions and improving real-world patient outcomes. Omitting this approach might mean missing the opportunity to develop more effective treatments that address the needs of patients. 

Shaping the future of CNS drug development and regulatory success 

The use of qualitative exit interviews in CNS clinical trials has implications for regulatory decision-making, particularly in enhancing the understanding of treatment efficacy and impact. The FDA has previously recognized the importance of incorporating patient perspectives to gain deeper insights into the real-world effects of treatments.iii 

Through its Patient-Focused Drug Development (PFDD) initiative, the FDA encourages sponsors to integrate patient experiences, needs, and priorities throughout the drug development and evaluation process.ii This is especially relevant for CNS conditions, which often involve complex symptoms related to mood, cognition, and quality of life that cannot be fully captured by traditional quantitative measures. 

By placing greater emphasis on patient-reported outcomes (PROs) and qualitative data, the agency is fostering a more holistic approach to assessing treatment effects.iv This approach offers additional context for interpreting quantitative data. 

To fully leverage the potential of qualitative interviews in supporting drug labeling, it is useful to incorporate qualitative exit interviews early in the clinical drug development process. Engaging FDA for input at the formal End-of-Phase-2 meeting is an optimal strategy. Before this meeting, however, several key considerations must be addressed: 

  1. Patient-centric approach: Sponsors are encouraged to integrate patient perspectives throughout the trial process. Qualitative exit interviews offer a structured way to collect firsthand accounts of the patient experience, revealing benefits and side effects that traditional metrics may overlook. 
  1. Contextualizing clinical outcomes: Exit interviews should provide valuable context, complementing quantitative data by offering insight into subjective elements such as emotional and social well-being, which are not reflected in standard assessments. 
  1. Regulatory guidance: FDA-issued guidelines stress the importance of rigorous methodology when incorporating PRO and qualitative data.iv  
  1. Study design and validity: Sponsors must ensure the validity and reliability of these qualitative exit interviews, encompassing bias minimization, seamless integration with trial design, and rigorous methodological approaches for data analysis. It is necessary to engage professionals with qualitative research skills and domain-specific indication knowledge, providing them with thorough training that covers interview techniques, and the challenges associated with interviewing patients with CNS disorders. Site investigators can be helpful contributors in this process. 

It is worth flagging that the European Medicines Agency and other health authorities have initiatives like the FDA’s PFDD, focusing on integrating patient perspectives into drug development and regulatory decisions.v 

Complementing data to illuminate the patient perspective 

In CNS clinical trials, qualitative exit interviews offer a powerful complement to quantitative measures by capturing the nuanced, patient-centered insights that traditional scales often miss. When implemented rigorously and early, qualitative methodologies enhance the drug development process, support regulatory decision-making, and ultimately drive the creation of more effective, patient-centered treatments. 

To learn more about how qualitative exit interviews can benefit your clinical trials, contact Premier Research today. Our team of professionals can help you capture the treatment benefits that matter most to patients and regulators alike. 

i Arnould, B., Gauchoux, R., & Meunier, J. (2023). Integrating qualitative interviews in drug development and the use of interview data by health authorities: A review. Frontiers in Medical Technology, 5, 1173988.  

ii Simmons A, O’Sullivan AK, Carpenter-Conlin J, Carty MK, Saucier C, McDonnell D. Using qualitative exit interviews to explore schizophrenia burden and treatment experience in clinical trial patients. Front Psychiatry. 2024 Aug 21;15:1377174. 

iii Food and Drug Administration. (2024, August 14). CDER Patient-Focused Drug Development.  

iv Food and Drug Administration. (2009). Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims.  

v European Medicines Agency. (2021, June 4). Progressing the concept of patient-centred development in practice. EMA.