Qualitative research in healthcare: Driving innovation in the pharmaceutical industry

• Social science theories and methods are particularly well-suited to explore the complex interplay of factors that impact patient experiences and behavior
• Patient empowerment movements have led to increased acceptance of social science research methods in healthcare product development
• For social sciences to succeed in a quantitatively-biased culture, it must find a place in the system where it can reshape and restructure evidence generation in a systematic manner

The pharmaceutical industry, which has historically relied somewhat exclusively on natural sciences and quantitative research methods, is undergoing a positive shift toward qualitative research in healthcare. That is,  incorporating social science-driven qualitative research methods into health research and industry practice.^1-4  Recognizing the limitations of quantitative studies, and the need to understand the humanistic aspects of healthcare, researchers in the pharmaceutical industry are turning toward qualitative methods to uncover deeper and more complex insights into patient experiences and behavior.³  However, this shift is not without challenges. Toward understanding the opportunities, drivers, and challenges of this changing landscape within the pharmaceutical industry, we discuss the emergence of social science research methods with select industry representatives and qualitative researchers.

Why is it becoming an accepted practice for pharmaceutical companies to conduct qualitative research in-house, or by outsourcing to qualitative research services? Social science theories and methods (whether quantitative, qualitative, or mixed) are best fitted to understand and explore a complex interplay of factors. In this case, patient lifestyles, preferences around treatment regimens, cultural differences, stigma surrounding disease, cognitive impact on treatment use, and experience with medications, may not be properly captured by statistics or the quantitative measurement of molecules in a medicine’s effectiveness.⁵

Recently, an ethnographic study was conducted by the authors across four healthcare organizations in the United States, focusing on general practitioners and endocrinologists. The team wanted to understand how clinical employees interact with the digital tools used in clinical practice, such as software for journaling, devices for diabetes glucose tracking, etc. The data collected through ethnographic observations and follow-up interviews was analyzed to identify barriers and further hypothesize unmet needs around the ways patients and doctors exchange information and ultimately receive and deliver care.  Rasmus Jensen, User Experience Research Lead at Novo Nordisk observed, “with the insights drawn from this research, we can trigger ideas that help lead to solutions that fit the reality of the people we design for. We can also support the development phases of prototyped products in a way that makes them fit more organically into the lives of users.”

Yet, not everyone is so open-minded.

Qualitative research in the pharmaceutical industry is still criticized – and receives more scrutiny than its quantitative counterpart. Scholars have observed, measured, encouraged, or criticized the value and impact of qualitative methods in pharmaceutical product development. They have questioned not only whether it is being used correctly and to its full potential, but also whether it is being used through applications that undermine its validity and reliability.^3,6,7 For example, a study conducted in 2017 assessed 21 papers on qualitative methods in health research and found that 14 of the 21 had a very low level of theory use and that the data analyses did not sufficiently elaborate on interpretive processes.⁶ So what are the barriers to qualitative research in healthcare, when compared with quantitative approaches? And what is its development potential? According to Jensen:

Qualitative research in a development organization may be significantly different from similar research in a commercial organization of the same company. While marketing and communication teams may have extensive experience with this type of research, the most obvious example being consumer focus groups, employees in the earlier stages of the value chain may not be as familiar with the value of these approaches. While brands are often launched after a deep qualitative understanding of the consumers (their preferences, cultures, and behaviors), there is less history around products being built out of the same knowledge.

Arun Micheelsen, Senior Specialist for Patient Insights at Lundbeck, finds the “qualitative vs. quantitative dichotomy” slightly unproductive. “The issue is not about qualitative versus quantitative methods. Instead, it is about the different epistemologies of the social sciences and the natural sciences – specifically, the ways in which they understand and interpret human behavior, experiences, and social phenomena,” says Micheelsen.

As he puts it, “Pharma has a long tradition of building on knowledge generated through the positivistic approach,” where knowledge is based on what is seen to be objectively observed or experienced. Micheelsen added, “a research tradition based on observing the impact of delivering placebo versus active ingredient is rooted in natural sciences, and it has significantly shaped the industry culture.” For social sciences to succeed in this positivistic landscape, it must find a place in the system where it can reshape and restructure it in a systematic manner.  Micheelsen continues:

Even qualitative approaches that have been in the industry for a long time, such as Usability Research, are traditionally anchored in the natural sciences focusing on criteria for safe and effective use. They do not include investigations of symbolic relationships with medical devices, or the socio-economic factors influencing device use in everyday activities such as playing with children, cooking dinner, etc. But there is a shift, clearly, and the social sciences are being recognized as essential and complementary.

When asked about the reasons behind this shift, Micheelsen suggests that patient empowerment has been pivotal to the recognition of the value brought by social science-driven insights. In the past decades, healthcare systems have become more and more attentive to patients, including a bigger role for patients in shaping care that has required an understanding of the human-centered and social perspectives of healthcare encounters. Micheelsen concludes, “Because ‘care’ is a social and humanistic phenomenon and medical treatment is by extension a part of ‘care’, healthcare systems, as well as industry, have had to increasingly embrace a more humanistic approach.”

Today, both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provide clear guidance and requirements for patient insights. Albeit not free from critique, their patient-focused drug development guidance is effectively nudging the clinical operations areas of pharmaceutical companies to adopt a more holistic perspective on the impact and experience of treatments. This may lead to an increase in the integration of social science research methods into product development.

Caroline Buhl, Industrial PhD student at the University of Copenhagen, is enthusiastic about the FDA recommendations for more patient engagement throughout the development process of medicines and medical devices. However, working at Biograil – a Danish-based startup – she also wonders what impact such guidance would have on smaller companies and startups if it becomes a requirement. “Conducting qualitative research, engaging patients at multiple stages of product development, running interviews and focus groups are fundamental activities, but they can be very costly,” says Buhl. She wonders: “What happens if only major companies with established patient panels and large resources to conduct sampled research multiple times can afford to meet such requirements?”

Mark Guarraia, Vice President, Future User Experience at Novo Nordisk has led multidisciplinary teams comprising different professional backgrounds, from anthropologists, psychologists, and UX researchers to designers and engineers. His teams have conducted research within the social sciences to support the development of physical and digital medical devices, such as pen injectors for insulin, across different therapy areas. According to Guarraia, “to make a successful product means ensuring that it fits and adapts to the life of the users – which, in the case of Pharma, is typically patients, caregivers, and/or physicians. And understanding whether a product may or may not fit, requires research.”

For Guarraia “the insights derived from the research should lead to clear actionable indications, and not merely remain knowledge” – a key competence needed for professionals taking the role of bridging empirical research methods and pharmaceutical practice. “Researchers should work alongside stakeholders to translate the outcomes of a study into tangible directions, such as design recommendations, input for product development, guidance, and actions,” says Gurraia. Achieving this enhances a company’s maturity in integrating social sciences research methods into practice, and facilitating smoother collaboration between the natural and social sciences.

Translating knowledge into action is, however, risky. “With quantitative methods, you may realize that the labeling materials in your new product are not well understood by 30% of the patients,” commented Buhl, “but only qualitative observations will show you what causes that 30% to misinterpret the label – be those cultural, cognitive, or contextual barriers. And if you don’t know what these barriers are, then you won’t know what to change.”

Unfortunately, learning what really matters does not necessarily tell us what to do to fix the problem. In other words, research is often descriptive, rather than prescriptive. Instead, research outcomes may result in new hypotheses to explore questions on how to fix a problem that has been identified. “The research process should be iterative, and it will most often require mixed methods. We often quantify things we know we want to measure, but if we don´t know what to measure, it’s the qualitative research that will help us find out what that is,” says Buhl.

So, is the industry equipped with the relevant profiles to embrace, support, and drive a social science transformation within the pharmaceutical industry? And does it mean that social science researchers may be in more demand soon?  

We think so. However, qualitative researchers must be prepared to address the perceived shortcomings that come with qualitative research.⁶ As qualitative research in healthcare has been shown to lack transparency regarding data collection and the interpretive processes implicit in the data, it is critical that researchers take time to address such concerns by making interpretations and interpretive processes explicit at all stages of research. Moreover, it is important that the theoretical foundations that serve as the background of the study are made clear, and it is essential to explain how these theories fit or do not fit into existing literature. 

Finally, to really make an impact, qualitative research in healthcare must avoid reductionism or studies that reduce or limit qualitative themes through overly quantitative processes, such as reporting how many participants referred to a thematic cluster, or comparing the frequency of certain observed behaviors. 

In an environment traditionally driven by quantitative methods, it is easy to be biased towards a positivist approach. Social science researchers have the task of showing both the practical and illuminating benefits of qualitative research to drive innovation in the pharmaceutical industry–a missing key to unlocking better health and patient care experiences worldwide.