Written by Linda Deal, Head of Health Outcomes Research, ERT
On August 23, 2011, the National Institutes of Health released a guidance entitled “Best Practices for Mixed Methods Research in Health Sciences”. The mixed methods refer to the combination of qualitative and quantitative approaches to addressing the treatment and prevention of illness and important public health issues such as treatment adherence and disparities among patient populations.
While this guidance targets researchers applying for NIH funding, it also serves as a useful supplemental reference to the FDA’s 2010 guidance to industry on patient reported outcomes. This NIH best practices guide provides useful definitions and parallels to the challenges faced by outcomes researchers in the Pharma and Biotech industry that are tasked with exploring and uncovering novel points of medical differentiation for the products they support. For example, in describing the nature of qualitative research and its evidence, the NIH guidance states “… Qualitative data help researchers understand processes, especially those that emerge over time, provide detailed information about setting or context, and emphasize the voices of participants through quotes. Qualitative methods facilitate the collection of data when measures do not exist and provide a depth of understanding of concepts.” When searching for the novel point of differentiation, it is often the case that existing measures are inadequate or lack the depth to capture salient concepts that are meaningful and understood only by the patients that experience an illness and during particular circumstances.
Another parallel of interest for the outcomes researcher is a section addressing teamwork, infrastructure, resources, and training. All four are of critical importance to the Industry outcomes researcher challenged not only to develop the measurement strategy to support a point of medical differentiation but to oversee a plan for executing that strategy. When developing a measurement strategy, it is important to acknowledge that “the questions driving the research initiative should determine the expertise required to address them.” Multidisciplinary compound development teams require a breadth of disciplinary membership but also the depth of subject matter experts such as health outcomes scientists. By understanding the NIH guidance and familiarizing with its references, health outcomes researches increase opportunities for securing a seat at the strategy table, exercising the depth of knowledge to facilitate an appreciation and regard for our science. Infrastructure, resources and training are all critical components to successfully implementing an outcomes measurement strategy. For an organization to reap the benefits of a measurement strategy, execution must be done well. Understanding the existing infrastructure and processes is essential before refinements addressing a measurement strategy can be addressed. This is especially important in an industry where delays in timelines can affect the future stream of revenues and resources are allocated among competing programs within a portfolio.
For access to the full NIH guidance, http://www.nih.gov/news/health/aug2011/od-23a.htm