EVIDENCE BASED INSIGHT

Clinical Evidence Generation — Why and How

FIGURE 1 | Clinical evidence generation is an ongoing process overseen by a governing body

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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.

FIGURE 2 | Comparison of randomized controlled trials with cluster randomized trials

Comparison of randomized controlled trials with cluster randomized trials

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.

FIGURE 3 | CEG communications strategy and partnerships

Clinical evidence generation in the middle of a venn diagram of the global medical office, marketing leadership and global research and development

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.

FIGURE 4 | CEG cross-functional matrix organization

Trail design and development, statistics, epidemiology, and publications

Meet The Experts

 

Peter Kotanko head shot

PETER KOTANKO, MD, FASN
Research Director, Renal Research Institute

Franklin W. Maddux head shot

FRANKLIN W. MADDUX, MD, FACP
Global Chief Medical Officer, Member of the Management Board, Fresenius Medical Care AG and Co. KGaAA

Olaf Schermeier head shot

OLAF SCHERMEIER, PhD
Chief Executive Officer, Global Research and Development, Fresenius Medical Care

References

  1. 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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