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In the evolving landscape of clinical trials, the voice of the patient is no longer a “nice to have”—it’s a necessity. One way to include the patients’ voice in clinical trials/ drug development, is through in-trial interviews (ITIs). ITIs are qualitative, semi-structured interviews conducted with clinical trial participants to capture their personal experiences of disease and treatment.
They are a source of rich, qualitative data and can be performed before, during and after the clinical trial, either as part of the clinical trial (fully embedded in the clinical trial protocol) or as associated interviews (with a separate protocol).
In this article we share our experience at admedicum, as a specialized provider in designing, executing and analyzing ITIs, about how these qualitative insights can transform both the scientific rigor and the patient experience of clinical research.
In the next article on this topic, further insights will be provided on the relationship between ITIs and HTA-related activities specifically, as patient reported HRQoL improvements are considered meaningful information for regulatory authorities, which more frequently requested direct patient reported data (Michel et al. 2023).
Enrich research findings: The Power of the Baseline & End-of-Treatment Design of In-Trial Interviews
When conducted at both baseline (prior to randomization/study treatment) and end-of-treatment (EOT) in-trial interviews offer a unique longitudinal perspective. This design allows patients to narrate their disease journey before and after the intervention (study drug or placebo) — capturing not just what changed, but also how it changed and especially how and why it mattered to patients. This allows for a holistic understanding of the patient’s disease experience before and after treatment which from a research and methodological standpoints entails:
- Having two qualitative, patient-reported assessments of disease experience.
- Enhancing understanding of symptom burden, treatment expectations, and HRQoL (Health-Related Quality of Life) as well as individual risk-benefit assessment.
- Supporting the interpretation of change in symptom burden and HRQoL beyond predefined survey responses—patients can describe symptom fluctuations, coping strategies, and meaningful shifts in disease management in their own words.
- Offering valuable feedback on trial design, feasibility, and operational aspects allowing to design more patient friendly follow up trials.
- Strengthening the content validity of endpoint assessments and can inform future PRO (Patient-Reported Outcome) development.
This defines in-trial interviews at baseline and EOT as an extremely valuable data source which enriches study assessments as they allow to capture patients’ opinions, their personal experiences and especially what possible symptom and HRQoL changes mean for their lives.
Why add In trial Interviews to Questionnaire-based Patient-Reported Study assessments?
Questionnaires are structured. Interviews are stories. While questionnaires capture what we expect to hear, interviews reveal what we didn’t think to ask. Patients can express nuances—like symptom interactions, HRQoL impact or emotional impacts—that are often lost in closed-ended survey formats.
This is especially critical when assessing change (e.g., symptom burden or HRQoL impact) over time, which is often an important endpoint in clinical trials. These patient-reported nuances in change of symptom burden and HRQoL impact beyond strengthening endpoint assessment can provide extremely valuable insights for HTA assessment and market access strategies (Williamson et al. 2025).
In this sense, ITIs do not substitute questionnaire-based endpoint assessments, but are a meaningful addition to them, as they can provide quality insights of the patient experience that questionnaires often miss to assess.
Patient-Focus in Action
Beyond being methodologically meaningful, from the patient’s perspective, being interviewed twice during a trial is more than data collection—it’s recognition. It’s a moment to be heard and to feel that their experience matters. From our experience at admedicum, this sense of being valued:
- Enhances trial retention and engagement.
- Makes participation more meaningful.
- Reinforces trust in the research process.
Participating in a clinical trial represents a great a commitment for patients, a commitment of time (for the patient and sometimes also their caregiver) and a commitment of trust, as patients take a risk when taking non-approved medication.
We believe that conducting baseline and EOT ITIs is one way to value patients’ commitment as it allows for their disease and treatment experience to be heard and makes their participation more meaningful, which supports trial retention.
Based on our experience at admedicum, ITIs empower patients to view their participation in clinical trials as meaningful and impactful. This perception arises from the value patients place on a thorough and personally relevant assessment of their condition, including changes in symptoms and HRQoL.
Conducting interviews at both baseline and end-of-treatment stages, rather than relying solely on questionnaires, enables a deeper understanding of the patient experience.
It reinforces the sense that their condition is genuinely acknowledged and understood. By allowing patients to share their individual experiences, ITIs foster a feeling of being heard and taken seriously.
This contributes to a broader sense of purpose, as patients recognize that their involvement supports drug development efforts that may benefit others in their patient community. Since contributing to future patient well-being is a key motivator for trial participation, ITIs serve as a valuable tool for both recruitment and retention.
Beyond the comprehensive assessment of symptom burden and HRQoL, repeated interviews throughout the trial enhance patients’ sense of being supported by trained professionals.
While ITIs are not intended to replace structured psychological or clinical support provided by trial sites, they do offer a consistent touchpoint that helps patients feel closely monitored and less isolated.
This sense of accompaniment can be particularly reassuring during moments of doubts or uncertainty, strengthening patients’ commitment to the study. In this way, ITI’s not only enrich the quality of data collected, but can also play a pivotal role in improving patient and retention throughout the clinical trial process.
Why Work with an External Partner?
In-trial interviews are generally conducted by a 3rd party, trained interviewer, as advised by the FDA (Michel et al 2023). This is important as it provides a safe space for patients to reflect on their experience, expectations, challenges, and suggestions concerning the clinical trial. In fact, specialized, external partners bring:
- Expertise in conducting semi-structured, open-ended interviewing.
- A neutral stance that fosters honest patient dialogue.
- Capacity to operate globally with a network of trained interviews around the globe.
- Experience navigating regulatory expectations and methodological rigor.
In this way, collaborating with external experts ensures smooth, impartial and high-quality data collection and analysis. This not only elevates the overall quality of the clinical trial but also strengthens subsequent activities related to HTA and market access.
At the same time, it enhances the patient experience and satisfaction, contributing to a more positive and engaging trial journey. admedicum experiences with ITIs have shown that these interviews are not just a research tool—they are a bridge between science and empathy.
Ready to Hear What Your Trial is Missing?
Book a 30‑minute discovery call with admedicum’s ITI team and find out how participant voices can streamline your path to market.
Bibliography
Michel, Anne-Sophie, Paul Kamudoni, Alexia Marrel, Rocco Adiutori, Céline Desvignes-Gleizes, Sally Lanar, Peter Schache, Erica Spies, and Josephine Park. "Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review." Frontiers in medicine 10 (2023): 1197529.
Williamson, Nicola, Chloe Howse, Nicola Hodson, Julia Stein, and Rob Arbuckle. "Qualitative in-trial interviews: methods, challenges, and best practice." The Patient-Patient-Centered Outcomes Research 18, no. 3 (2025): 199-209.
