the way of water
Implementation science: the way of water
In his commencement speech at Kenyon College in 2005, the author David Foster Wallace began with a parable:
“There are these two young fish swimming along, and they happen to meet an older fish swimming the other way, who nods at them and says, “Morning, boys. How’s the water?”
And the two young fish swim on for a bit, and then eventually one of them looks over at the other and goes,
“What the hell is water?””
The point of the story is that the most obvious, important realities are often the ones that are hardest to see and talk about. Anyone familiar with the world of strategic marketing for pharmaceuticals will be aware of the view that product positioning should inform Phase III clinical development rather than be conceived as a response to its outcome. The same people will also recognise that this scenario is rarely realised: marketeers are used to making the best of whatever pops out of the pipeline, the familiar refrain of ‘if only’ notwithstanding.
A similar case is now being made for the emerging discipline of implementation science. The goal here is to avoid the long delay that typically occurs between the fruits of clinical research becoming available and their widespread application in clinical practice.
No-one assumes that the mere publication of ‘practice changing data’ will lead automatically to practice change. It’s not just whether something works, but whether it can be delivered in a wide variety of real-world settings.
Implementation science is the study of methods to promote the integration of research findings and evidence into healthcare policy and practice.
Rather than clinical effectiveness, the endpoints of interest for implementation studies include things like
- acceptability,
- appropriateness,
- feasibility,
- implementation cost,
- and sustainability.
An impassioned case for pharma to embrace implementation science has been made recently by Melvin Olson and Linda Rootkin from Novartis, who maintain that while the value of implementation science is increasingly recognised, it has not yet been broadly adopted by industry.
They point out that implementation is as relevant to healthcare delivery as safety and efficacy but is typically addressed only after regulatory approval and access authorisation have been secured. The result is delay in answering key questions and ongoing challenges to patient access. Olson and Rootkin advocate the integration of implementation science at an early stage of the development pipeline, suggesting this is:
‘not a ‘box-ticking’ exercise [but] a change in mindset and a departure from the traditional models of drug development’.
Implementation scientists, they say, should feed into study design early in Phase II and Phase III clinical research.
It could be argued that most in pharma are like the young fish in in Foster Wallace’s parable, and that Olson and Rootkin are merely playing the role of the older one. After all, interest in driving the widespread adoption of evidence-based practices is hardly new, and many will recognise implementation science as their day job.
Nevertheless, there is perceived to be value even in simply having implementation science as an umbrella term, particularly in giving coherence to a multidisciplinary endeavour that is usually pursued, like much in pharma, across distinct siloes. And awareness that implementation science ‘is a thing’ will help to ensure issues such as those raised by Olson and Rootkin are brought into focus and properly considered.
As David Foster Wallace put it, the key thing is to maintain
‘awareness of what is so real and essential, so hidden in plain sight all around us, all the time, that we have to keep reminding ourselves over and over: this is water’
END.
References:
Wilson P and Kislov R. Elements of Improving Quality and Safety in Healthcare: Implementation Science. Cambridge University Press 2022. DOI 10.1017/9781009237055
https://www.cambridge.org/core/elements/implementation-science/9E9361E2F6C1A3B894C6D202031ECD19
Bauer MS, et al. BMC Psychology An introduction to implementation science for the non-specialist. 2015;3:32
https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-015-0089-9
Olson M and Rootkin L. The triple win – implementation science benefits patients, healthcare systems and industry alike. J Comp Eff Res 2022;11(9):639–642
https://becarispublishing.com/doi/full/10.2217/cer-2022-0058
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