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.
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.
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.
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 info@vitaccess.com.
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By Fatemeh Amini, Sally Vincent, Sam Llewellyn
References
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products
- https://www.cadth.ca/sites/default/files/Drug_Review_Process/patient_input_guidance.pdf
- https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-parallel-ema/eunethta-21-joint-scientific-consultation_en.pdf
- https://www.ema.europa.eu/en/documents/report/report-workshop-patients-voice-evaluation-medicines_en.pdf
- https://www.ncbi.nlm.nih.gov/books/NBK542736/
- https://www.frontiersin.org/articles/10.3389/fmed.2023.1197529/full
