In October 2023, the US Food and Drug Administration (FDA) released their industry guidance for benefit-risk assessment of novel products¹, in which the role of patient experience data was highlighted in its capacity to “inform nearly every aspect of FDA’s benefit-risk assessment…throughout the drug lifecycle”. Further to this, Canada’s Drug and Health Technology Agency (CADTH), the European Network for Health Technology Assessment (EUnetHTA), and the European Medicines Agency (EMA)2-4  have each published guidance asserting the value of patient preference studies in regulatory and reimbursement decision-making.

With industry, the scientific community, regulatory agencies, and HTA agencies increasingly recognizing that the patient voice can, and should, be included at all stages of drug development and evaluation, investigators are encouraged to support their product’s value story with qualitative patient preference data. An increasingly popular format is the trial interview, in which qualitative data on the experiences, perspectives, and priorities of patients or caregivers can be captured before, during, and after a clinical trial.  

Close-up on the back of a middle-aged psychotherapist holding a pen and a blurry female patient's silhouette facing him

What are the use cases of trial interviews?

When implemented prior to the launch of a clinical trial, patient interviews can allow for pre-treatment experiences and expectations of the population of interest to inform or contextualize the subsequent trial and its outputs. Further to this, pre-treatment interviews could allow patients to describe potential barriers to participation in or adherence to clinical trials, thereby providing investigators with valuable information that could inform recruitment and retention strategies. 

Conducting interviews during or after clinical trials, on the other hand, can provide complementary insights to support and enrich trial data, in turn painting a more complete picture of treatment efficacy and safety. As well as providing the opportunity for patients to articulate the impact of treatment on their symptoms or any anticipated or unanticipated changes, in-trial or exit interview data can additionally support traditional trial endpoints (including patient-reported outcome measures), alongside allowing patients to comment on their experiences of participating in the trial itself. 

Moreover, combining two or more of entry, in-trial, and exit interviews can provide rich, longitudinal information on the changes in patients’ lives resulting from new therapies. Table 1 provides an insight into concepts frequently addressed in trial interviews, while Figure 1 shows associated use cases.   

Interview Concepts
Symptoms and impacts before the study
Expectations of changes or outcomes
Anticipated or unanticipated changes, and the impact of those changes
Treatment experiences
Satisfaction levels with treatment
Topics for Exploration
  • Symptoms experienced
  • Impacts of reported symptoms
  • Most bothersome/important symptoms
  • Pre-study expectations (can be compared with actual clinical outcomes)
  • Changes/outcomes noticed
  • Impact of treatment on most important/bothersome symptoms
  • Onset of changes
  • Impact of treatment on functioning and quality of life
  • Convenience of treatment
  • Managing treatment schedule (e.g., regimen, infusions, monitoring)
  • Challenging aspects of study treatment
  • Managing adverse events
  • Satisfaction ratings
  • Reasons for satisfaction
  • Table 1 Concepts frequently explored in patient interviews. Adapted from DiBenedetti 2018 5 
    Trial interviews_When are Qualitative methods helpful
    Figure 1 Use cases of trial interviews

    How do you do trial interviews well?

    For the patient perspective to be meaningfully captured and implemented in the context of trial interviews, proper design, conduct, and analysis is of paramount importance 

    Tip 1: Estimate the number of interviews, prepare your discussion points, and pre-define the sampling method.
    Tip 2: Recruit qualitatively trained, neutral third-party interviewers the quality of the data depends on specific skills and interviewing techniques.   
     Tip 3: Choose the appropriate mode of administration (e.g., in-person, online/via video conference, telephone).
     Tip 4: Choose the appropriate setting (i.e., one-to-one interviews versus focus groups).

    At Vitaccess, we have extensive experience in capturing patient experience data using methodologies that meet the research objectives and timeline restrictions of our clients – including entry, in-trial, and exit interviews. If you would like to find out more about our capabilities, get in touch today at 


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