In 2022, the FDA began developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address how healthcare stakeholders can incorporate the patient voice into the drug development process. These materials indicate that the need to listen to patients is a clear priority for the FDA, and soon, it may be more than just a “nice-to-have”; we are likely not far off from patient input in the clinical trial process being mandated.
The second of these guidance documents, “Patient-Focused Drug Development: Methods to Identify What is Important to Patients,” highlights the benefits and drawbacks of various qualitative, quantitative, and mixed methods research types. In response to this guidance, we have shared how inVibe’s asynchronous, anonymous Listening Platform makes it easy to collect qualitative data from patients with the efficiency and scalability of quantitative research. Yet, when we pair our voice response design with our quantitative capabilities, we open up a new world of nuanced mixed methods research.
The benefits of mixed methods research
When considered separately, quantitative and qualitative research each have their own strengths. Quantitative research is scalable, quick, and cost-effective: a perfect option for hearing from a large sample in a short time. While qualitative research typically involves a smaller sample, it provides unparalleled depth and detail behind respondent thoughts, feelings, and behaviors. Depending on objectives, there are plenty of reasons to use one methodology over another.
But if quantitative and qualitative are great on their own, they’re even better together. Combining these two approaches enables trial sponsors and CROs to get to the “why” behind the “what.” Through quantitative surveys, patients share what their thoughts are, often via closed-ended rating, visual scale, ranking, and yes/no questions. Qualitative research subsequently elicits why these quantitative answers were given, offering opportunity for elaboration in an open-ended context. These complementary methods are sure to generate a robust, multifaceted data set regardless of context, but a combined approach specifically in the clinical setting ensures the industry is developing products and services that truly address the needs of patients.
The inVibe approach to mixed methods research
At inVibe, we strive to blend qualitative and quantitative mediums at every step of the process to ensure one story is told seamlessly. Let’s look at two key elements of a mixed methods project — design and analysis — to see just how integrated our approach is.
Design: The inVibe research arm is one unit. While individuals in the department may have more experience in qualitative or quantitative research, we are not siloed by our expertise. This means that for a mixed methods project, we compile one team that embodies both our quantitative and qualitative capabilities. This team works together throughout the entire project lifecycle, starting with research design. All members first collaborate on the quantitative portion of the survey, designing a comprehensive set of questions that broadly elicits perceptions and behaviors across a range of topics. We then turn our sights to the qualitative portion, where we craft open-ended voice response prompts that probe on select aspects of the quantitative portion. By the end of this design phase, such a cooperative approach yields a unified yet multi-dimensional survey covering both general and specific areas of interest.
Analysis: Once all of the responses are in, we look at all of the data holistically. Since we intentionally devised complementary quantitative and qualitative questions in the design phase, we need to analyze them in tandem. Turning first to the quantitative findings, we gather the bird’s-eye view of what respondents are thinking. Moving on to the corresponding qualitative findings, we fill in the details of why that is the case. The seemingly disparate pieces of the puzzle fit together seamlessly, providing breadth and depth around each theme.
Analyzing qualitative data can be messy, but the inVibe methodology addresses these challenges in a structured, standardized, and scientific manner. By obtaining acoustic baselines for each individual respondent and asking all respondents the exact same questions in the exact same way through pre-recorded prompts, inVibe is able to structure what is traditionally unstructured qualitative data. This scientific data collection method is what makes it possible for us to analyze both acoustically through machine learning and linguistically through our expert linguistic analysts. The combination of the methodology with the technology then allows our team to identify similarities, differences, and trends, and roll up larger sample sets to reveal speech emotions and deep insights.
Get to the 'what' and 'why' now
In short, we believe that merging quantitative and qualitative research into a unified undertaking through our simple, systematic, and scalable methodology is the best of both worlds for clinical research. Cohesive design, analysis, and reporting unlocks levels of knowledge that is greater than the sum of its quantitative and qualitative parts. By understanding both the “what” and the “why” behind patient responses, we can make more impactful recommendations to ensure patient-focused drug development in your study and ultimately bring better and more personalized medicines for patients.