Avoiding The Gas-Guzzler: 8 Steps To More Productive Observational Studies

By Jeff Trotter, Executive Vice President, Phase IV Development

The automobile industry is in a precarious state. With factories designed to churn out light trucks, SUVs and other gas-guzzlers, the industry has been ill-prepared for the shift toward energy-efficient vehicles. Whether its denial or archaic thinking or lack of responsiveness or inflexible factory design it’s pretty clear that Detroit (and even Tokyo) has  encountered a perfect storm certainly exacerbated by a global economic meltdown, but one nonetheless largely on their own making.

Is this an allegory for the pharmaceutical industry? Perhaps. I’ll limit the metaphor, however, to the subject of research studies, and specifically to observational, non-interventional studies. Suffice it to say that our industry needs to retool in order to costeffectively respond to the need for these unique types of studies. Analogous to producing an SUV when a Smart Car is what’s really needed, while observational studies may be able to utilize certain standard parts from the research process assembly line, a fundamentally different perspective is required overall to respond to what the consumer really wants.

They go by different names: “real world” research; noninterventional study; observational initiative; “late stage” research programs; epidemiological survey; post-marketing surveillance; patient registry; post-approval, non-interventional, observational, real world outcome trial. The common theme is to measure without interfering with what’s being measured; in other words, to observe and, of course, to learn something along the way. However, the specific words and phrases employed to describe a study, while not unimportant, tend to cloud study’s underlying intent. The strategic purpose – the business rationale – behind the study all too often gets lost in the dust when getting a research program started. This is far more critical than many industry professionals realize, as it’s the study’s strategic purpose that drives how the study should be “operationalized,” and as such, directly impacts not only its budget, but also its outcome. This is most acute in the case of post-approval, observational studies, for which the industry often employs practices and perspectives designed for pre-approval, interventional research and, in so doing, ends up with a gasguzzling study.

So in shopping for the energy-efficient vehicle that is an observational study, the first step is to:

1. Re-think What Transportation is Needed! – The observational study is a means to and end; a mechanism for getting you to your destination. The other words, an observational study can be a response to a number of business issues, ranging from a mandate for safety data to the need to document a product’s „real world‟ economic value or, as is the case increasingly, somewhere in between. The goal is to demonstrate safety and/or economic value, typically in a post-approval setting; the vehicle is the observational study. IT is critical to consider this context as it will inform how the study is designed and undertaken – what specific type of care you need to get you where you’re going. Don’t assume the car you’ve always bought is the right way to go this time!