EVIDENCE BASED INSIGHT
Clinical Evidence Generation — Why and How
In RCTs’ simplest form, patients are randomly allocated into two groups (“arms”) that undergo specific interventions, e.g. a treatment with different dialyzers. Well-designed RCTs provide the highest level of evidence, because known and unknown patient factors are balanced between the two arms through the randomization process. Over the years, numerous RCT variants have been developed. However, RCTs frequently call for often complex inclusion and exclusion criteria that may limit generalizability of results to the larger population of interest.
In conventional RCTs, patients are randomized; in cluster randomized trials, the unit of randomization is a group, such as an entire dialysis clinic or geographic region. Cluster randomized trials are the main tool used in pragmatic clinical trials (Figure 2). Given the sheer scale of Fresenius Medical Care, with its thousands of dialysis clinics worldwide, this trial design holds great promise. Fresenius Medical Care North America has practical experience with this type of randomized trial. Pragmatic trials may test the same interventions as explanatory trials, but they are conducted in real-world clinical practice settings and the eligibility requirements are often relaxed. In general, pragmatic trials demonstrate a better sense of how an intervention works in the real world.
To be successful, CEG requires an elaborate communication strategy (Figure 3). CEG is most effectively communicated through publications in journals respected by all stakeholders. A spectrum of publications is necessary to cover various aspects of a product, such as a new dialyzer. These individual publications, large and small, are like dots in pointillistic artwork: They create an all-encompassing description of a product. Of course, a successful product launch requires a host of additional activities such as marketing, product placement, and pricing, to name a few.
CEG is not a tick-box exercise. It requires a deliberate, focused, and well-coordinated cross-functional approach, bringing together different skill sets from across Fresenius Medical Care (Figure 4). Given the organization’s many talented and dedicated top-notch employees versed in planning and conducting research, the company is well-equipped to successfully execute CEG research. In doing so, Fresenius Medical Care is dedicated to serving patients, caregivers, healthcare professionals, and larger societal health goals, in conjunction with meeting company objectives.
Meet The Experts
- Sackett DL. Evidence-based medicine. Seminars in Perinatology 1997 Feb;21(1):3-5. https://doi.org/10.1016/S0146-0005(97)80013-4.
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