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Real-World Evidence as a Trailblazer of Data Medicine

Dr. Thilo Löwe, 10. April 2020

Real-world evidence is about to become the buzzword of the healthcare industry. Be it a cost- and timesaving supplement for randomized controlled trials in pharmaceutical research, a basis for AI-based diagnostics, personalized medicine, or the certification or proof of efficiency for digital health applications, the magnitude of real-world evidence as the cornerstone of data medicine—not least of all in economic terms—has since become beyond dispute. This is not surprising, for over the past few months, a number of startups, mostly American ones, have succeeded in obtaining sizable funds to develop real-world evidence platforms. In Germany and Europe, by contrast, this development is still at its inception. We at nxt statista are working with our clients on changing this soon.

In the United States, generous amounts of financing have been amassed by a category of startups that have largely flown beneath the radar in this part of the world: so-called real-world evidence platforms that aggregate medical treatment data from various sources, thereby supporting medical research projects. Among these are:

Illustration 1: Recently-established medical startups with a connection to real-world evidence

An additional example is the oncological real-world evidence platform Flatiron Health, which was acquired by Roche for USD1.9 billion in 2018.

What is the reason for these high valuations? The aforementioned platforms follow different business models—from pure data collection and aggregation, to solutions for data swapping, to software tools for customized patient therapy in cancer centers. Their common ground is the aspiration to reduce costs in developing medications and to increase the accuracy of fit in therapies by using real-world data. In the long term, the use of machine learning and AI will also play an important role. The following sketch illustrates this approach for the pharmaceutical industry:

Illustration 2: Influence of real-world data on the development of new medications

As early as 2016, IQVIA calculated savings of 15% in pharmaceutical research using real-world evidence would add up to a worldwide total of more than US$27 billion.

Sources of „Real World Evidence“

In comparison to the U.S.A., the availability of real-world evidence in Germany remains quite restricted. In Germany, for example, the electronic patient file (which has been mandatory in the USA with the HiTECH Act since 2009) will not be introduced until next year. For this reason, the „Zentralinstitut für die Kassenärztlichen Vereinigungen“ (ZI) only provides billing data of public health insurance companies to physicians and scientific research institutions (with a considerable time delay).

With the introduction of electronic patient files and digital health applications as well as the comprehensive rollout of the teleinformatic infrastructure, this situation will change in Germany in the years ahead. It is already possible to construct physician panels by way of plug-ins into medical practice management software and obtain data about specific patient groups using digital health applications. But even here, we have to contend with a time requirement of one to two years until a representative amount of data has been achieved.

You can find an overview of the most important potential data sources for real-world evidence here:

Illustration 3: Potential data sources for real-world evidence

Beginnings of Real-World Evidence Platforms in Germany

In Germany, the setup of real-world evidence platforms primarily belongs to the world of university research. In addition to the national longitudinal study (NAKO Gesundheitsstudie), the data integration centers of the Medical Informatics Initiative of the Federal Ministry for Education and Research, or BMBF as well as the „Hamburg City Health Study(HCHS) are especially worth mentioning here. Here, the focus resides primarily in the preservation of data in a clinical and/or in-patient context The chief private provider of real-world evidence data is currently the American company IQVIA, which runs a panel with several thousand physicians in clinical as well as in-patient sectors. Yet at the moment, this situation is changing, and since 2019, increasing numbers of initiatives are coming into existence, in Germany as well, to set up real-world evidence platforms. Among them are:

  • Data4Life: A charitable initiaitve of the Hasso Plattner Institute. At the moment, the focus is on the development of a European solution for distributing and collecting health data within the framework of the "Smart4Life" consortium.
  • Urogista / Uroscience: Initiative of the "Deutsches Institut für fachärztliche Versorgungsforschung" (DIFA) and the "Berufsverband der Deutschen Urologen e.V." (Professional Association of German Urologists) to automate notifications for the cancer registry via "plug-ins" into the medical practice management system, store them in a central database, and with that said, facilitate the participation of urologists in studies and health care research projects.
  • Docmetric: Initiative of CompuGroup Medical AG to use the CGM medical practice management systems to obtain real-time statistical information on diagnoses and treatments.

We at nxt statista advise and support various clients in setting up health-related databanks and real-world evidence for health services research. At the same time, we apply our wide-ranging Statista know-how to automize the integration and quality assurance of various data sources, our data science and machine-learning expertise to prepare data and to obtain data-driven insights, as well as the nxt statista team's 15 years of experience in setting up digital business models for guaranteeing long-term monetization.

Contact us if you also wish to tap into the revenue and efficiency potentialities of real-world evidence for your business.

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