-Guest Blog by Andrea J. Simon, PhD.-
In the past year, pressures to integrate observational or ethnographic research (which really are one and the same) in pharmaceutical and biotech industries are increasing as the value of this research is becoming better understood. In particular, Phase IV research involving the management and use of a drug protocol is becoming more and more important; i.e., when a drug is in widespread use, risks need to be better understood. At the same time, there is a growing sense of uncertainty around ethnography’s legitimate role, how to integrate it into quantitative research, and when to use its information and insights to support or alter a previously defined direction. Along with this greater scrutiny, there is rising debate about ‘best practices’ in observational research processes, especially regarding the need to define protocols to ensure that research is conducted with proper rigor and is producing suitable, credible results.
To some degree, the popularity of the TV series “Undercover Boss” has generated its own spin-off of interest in shadowing staff or customers, spending a ‘day in the life’ of a customer or staff member, or using similar ethnographic tools to better ‘see, feel, and think’ about what is happening in a critical part of a business, hospital, or physician-patient interaction.
Is there legitimacy in the application of this type of field work, observation, and ethnographic research in pharmaceutical and biotech applications, resulting in better-designed products, delivery systems, and drugs, and ensuring their safe use?
As a corporate anthropologist, I offer a resounding yes. Recently, I have become very interested in the application of classic qualitative research to the pharmaceutical and biotech industries at a time when other research techniques may simply not provide sufficient and accurate data points necessary to design practical solutions. In these fast-growing industries, there is unmistakably a growing demand for observational research – for example, how to find solutions that will mitigate risks in REMS communication plans and medication guides. This type of research is becoming particularly relevant to the discovery work needed to demonstrate effectiveness around REMS implementation plans and the Phase IV clinical trials associated with post-commercialization communication processes. Manufacturers are increasingly becoming convinced of the necessity to use innovative research tools that are not revisions of earlier approaches used to support a drug’s original development.
It is well worth noting that ethnographic studies have been used in the pharmaceutical and biotech arenas for some time. DuPont Pharmaceutical’s development of its software system in the late 1990s to manage anticoagulant Coumadin was partially the result of ethnographic research conducted to better understand why some doctors readily prescribed Coumadin, while others were reluctant to prescribe it to patients who were clear candidates for the drug. The research-generated insights led to the realization that the drug was not the issue – it was the management of the patient taking the drug. Without addressing that part of the equation, healthcare providers were assigning a higher than necessary risk to the drug.
Today, drug manufacturers are experiencing more pressure than ever to go further than the actual drug clinical trials—in essence, to delve into how a drug is prescribed, used, and integrated into a patient’s larger health plan. As Jeff Trotter writes in his CRO blog, “Pharmaceutical companies are facing increasing pressures not only to bring new medicines to market, but also to demonstrate both long-term safety and ‘real-world’ value (i.e., clinical performance, cost-effectiveness, and improved quality-of-life). There is increasing recognition in all sectors that the conditions under which products are examined for approval are not the conditions under which they may actually be used” (http://blog.pharmanet.com/post/Observational-Research-Observing-Drugs-e2809cin-the-Wilde2809d.aspx). I heartily agree.
On a parallel track, the use of observational study offers an approach that helps account for the complexity of group behaviors, reveals qualities of interactions in behavior that are unknown to the participants themselves, and allows researchers to plot trends and patterns in behavior that would be difficult to capture through interviews, focus groups, or quantitative research.
There is considerable evidence from a variety of applications that this kind of research is enormously valuable. At the same time, it is rather amorphous and often requires better clarity in its form and application. In its January 2010 issue, The Lancet announced its intention to register protocols for observational studies. Its argument was that observational research was highly valuable as a way to provide necessary information to improve “decision making, aid systematic reviews, and reduce waste from duplication of research. The crucial question is whether registration, by improving the transparency of observational research, would lend greater credibility to its findings, or if such a move would stifle creativity and delay the communication of important insights.” (The Lancet, Volume 375, Issue 9712, Page 348, 30 January 2010)
Yet, while recognizing the need for informed research design, they have vigorously encouraged ethnographic research to better understand the use of drugs in real-life settings. In January 2006, for example, they encouraged the use of “…rigorous qualitative research methods, including focus groups and key informant interviews,2 and ethnographic investigations3 could provide an empirical basis for theory-based interventions (e.g., diffusion of innovations4) and social marketing strategies5 to support successful fieldwork and preparation on the part of trial investigators and to develop best practices in engagement with local communities. “ ( The Lancet, Volume 367, Issue 9507, Page 302, 28 January 2006)
This is particularly important when we set observation into the context of a growing body of research from the neuro- and social sciences which make it increasingly clear that people have a difficult time describing what they are doing, when in fact their deep habits and long-held patterns of behavior are driving their actions. They often prefer to tell you what they think you want to hear rather than what’s really going on. Repetitive habits take over; mind-mapping influences what they think and believe they are doing.
This phenomenon is why marketers have long believed that ‘buyers are liars.’ Although well-intentioned, people really do not know what they are doing or why. Focus groups have their place but often generate more of the ‘ought’s’ or rules rather than the realities. People are pleasers and therefore can be highly influenced by an individual or by the interactivity of a group. Insert some observations into the inquiries and you will be able to see, feel, and think about what a person or a group is doing in ways that they are unaware of. This is why we value ethnographic research – it challenges the brain’s mind map and helps us see things in ways that the participants cannot. (Soon C, Brass M, Heinze H, Haynes J (2008) Unconscious determinants of free decisions in the human brain. Nature Neuroscience 11:543-545; Webb T, Sheeran P (2006) Does Changing Behavioral Intentions Engender Behavior Change? A Meta-Analysis of the Experimental Evidence. Psychological Bulletin 132:249-268.)
Ultimately, the tension between having protocols registered for observational research and the need to conduct research more often and in the right way is going to intensify. That is why it is particularly valuable at this stage to establish some of the current parameters for observational research among anthropologists and others who apply ethnographic techniques. This research allows us to better see, feel, and think about cultural situations where information is best gathered by observing what people are doing and listening to their stories about those activities. Hopefully this will be helpful as you evaluate when to use ethnography appropriately and how to use it in the right context as a powerful tool to answer questions about culture, behaviors, the values behind those behaviors, and the beliefs that people hold to be true. Far from being anecdotal observations incidental to a critical decision, observational research will lead to better data, information, insights, and best of all, solutions.
As with most investigation, observational research has a process. In the next series of blog postings I am going to discuss these further. Rather than debate the pro’s and con’s of observational research in the pharmaceutical arena, my preference is to provide a perspective on what it is, how it is done and how to customize the approach to fit different questions about how to improve our understanding of the use, misuse and abuse of drugs as REMS grows in importance.. The intent is to provide a guide or checklist for you of some of the aspects to consider before employing observation for better insights surrounding the utilization of a drug in its real-life application.