Evolution of clinical trials – A plea for trials within health insurance systems
Since RCTs normally come along with high costs and organizational expenditures, studies with alternative designs are also being conducted, such as so-called pragmatic trials. The objective is to design and conduct these trails similar to the functionality of the health system in everyday life. Hence, the trials have boarder inclusion criteria, and nonadherence and "loss to follow-up" were considered in the results as physicians have to deal with this and other problems daily. However, pragmatic trials are often difficult to analyze because, nonetheless, they are very similar to classical RCTs.
Furthermore, registry randomized trials exist, where patients get identified through disease registries and are then included in the trials. The disease registries contain infrastructure for the contacting of patients and for data collection. Unfortunately, these disease registries only exist for a few diseases so far as they are expensive to maintain. Dr. Choudhry concludes that the advantages of both alternative trials could be combined in trials within health insurance systems. In such studies, the data collected by health insurances can either be used to identify patients or to define study endpoints and evaluate them in the same step.
Not only could these trials investigate new medical procedures and drugs that are already approved by the authorities in realistic care settings, but also how insurance itself should be structured.
The author describes several examples of successful studies within health insurances but also bears in mind, that such studies are rare so far. He describes, what could be possible in the future if the different parties like health care providers, insurers and researchers would cooperate more closely and share their data with each other.
From our experience with digitalization processes within the healthcare and health insurance market at SKC we know, that the digitalization of the health care sector results in great opportunities for research, because more precise patient data is collected which can be analyzed across different disciplines if centrally available. Meanwhile, this is occasional applied, for example in antibiotics research, where hospitals and pharmacies share their data on antibiotics usage throughout the different wards with specific companies specialized on gathering and analyzing this data. Thus, the companies in cooperation with the hospitals monitor resistance and special implications of antibiotic usage in certain disciplines in a greater framework.
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