Interviewing patients in clinical trials is an opportunity to let the patient voice be heard.
Qualitative research is important in clinical development; this is true for two reasons. First, the life sciences industry is committed to taking a patient-centric view of clinical development. Indeed, regulatory bodies and health technology assessment (HTA) bodies encourage companies to understand what is important to patients in clinical studies and disease treatment. What better way to do this than via direct interaction with patients to elicit their thoughts and experiences? Second, qualitative research methodologies have matured. Interviewing patients in clinical trials is a valid approach to understanding the patient perspective of a disease or treatment, providing context for explaining and interpreting quantitative clinical data, and informing future outcome assessment strategies and trials.
Essential knowledge gained in patient interviews
Patient interviews can be used to further the goals of patient centricity on multiple levels. In the planning stages, they provide insight into the natural history of a disease, the burden of illness, and concepts of interest related to a condition – all of which inform the research strategy and ensure that it will serve patients' needs. Patient interviews also help in refining the conceptual model of the study and support the development of patient assessments that are appropriate and valid.
Patient interviews can further explain the evidence generated at a more operational level and shed light on the significance of specific quantitative outcomes – insights of interest to regulators, HTAs, and payers. After all, physiological measures and biomarkers don’t detect changes in patients' perceptions of their overall health, nor can they explain why treatment benefits are meaningful.
And finally, interviews with patients can enhance value communications with direct quotes, specific narratives, and a broad assessment of the trial experience. These may, for instance, speak to ways to improve patient engagement during future trials and the patient's propensity to continue treatment or recommend it to another patient. The trial participant is, of course, the only direct source of experience with the investigational product before approval.
Types of patient interviews
Interviews with patients in clinical trials are one-on-one, semi-structured interviews conducted with patients or caregivers to better understand, characterise, and document the impact of a disease, potential therapy, or a clinical program from a patient's perspective.
They can be conducted in person, by phone, via video conference, at the trial site, or in the patient's home. Patient interviews can be performed during the initial screening interview, be part of scheduled assessments during the trial, or conducted as exit interviews at the end of the trial.
When patient interviews are important to clinical trials
The qualitative data gathered via patient interviews can be valuable in any therapeutic area but are particularly useful in studies of rare diseases, chronic diseases, and surgical interventions. We recommend that they be used when:
- The natural history of the disease is poorly known or not well-described in the literature
- Insights will be sought on clinical parameters not measured in a trial (such as the onset of action or duration of therapy)
- Regulatory submissions will require supporting evidence of content validity of primary or key secondary endpoints
- A small patient sample and lack of valid, specific measures will limit benefit/risk assessment and value communication
- Regulators are likely to challenge the clinical meaningfulness of the magnitude of change or difference
- It will be important to develop strategies to promote adherence to the therapy
A final recommendation
Qualitative research in the form of patient interviews can enrich clinical trial planning, operations, and outcomes, but only if the interviews are carried out according to the highest research standards. The interviews should follow a carefully crafted discussion guide that allows for flexibility to explore new information or probe on points of interest, while honing in on the topics that need covering. And interviews must be conducted by an experienced interviewer who can remain neutral, has the skills needed to help patients articulate their views, and is familiar with the ethics of interviewing vulnerable populations. It is not a task to be delegated to healthcare providers, care providers, or study staff, but rather should only be trusted to seasoned interviewers familiar with study materials, focused on the goals of the research protocol, practiced in qualitative methods, and unrelated to a patient’s actual care or personal life, allowing for candid appraisals by the patient. It is the patient voice we need to hear.
 Lapuerta P. 2012, Ervin CM 2017, Anthony L 2017, Nunn A 2016, Ori M 2013, Pederson B 2017, Bharmal M. 2018, Jenkins N 2011, Turner KM 2008.