Fighting COVID-19 with dataThilo Löwe, 08. Oktober 2020
The importance of medical data for combating diseases has never been more evident than during the corona pandemic. It is not only about recording the outbreak in as much detail as possible and on a real-time basis; the disease needed to be understood in the first place by exchanging observations and findings, and best-practice benchmarks had to be developed pertaining to specific patient groups and symptoms. This process is far from being completed, especially with regard to long-term health implications.
Using data to develop effective vaccines
Another task that will also need to be tackled, probably in 2021, is observing the efficacy and safety of COVID-19 vaccines on a long-term basis and in all segments of the population. Since the approval process is being carried out under immense time pressure, it is unlikely that trial data from all subpopulations, let alone long-term data, will be available before a vaccine's approval. Moreover, because of the overall low incidence of the virus, the Phase III trials conducted by then will only allow limited conclusions as to the efficacy of the vaccine. It will also be interesting to see whether and to what degree institutions such as the EU will accept trial results from other regions for their approval process. A conditional marketing authorization for COVID-19 vaccines is to be expected, with vaccine producers being required to conduct post-authorization efficacy studies to confirm the vaccine's efficacy.
Due to low incidence rates, it will be necessary to observe a wide sample of the population in this post-approval phase, and when safety is at stake, the data will ideally need to be available in real time. As such a wide sample will also need to be observed over a long period of time, the costs must be kept within reasonable bounds. Nevertheless, the corona crisis has already made it abundantly clear that we should not limit ourselves to a simple system with doctors reporting COVID-19 cases. The relevant data should be transmitted automatically, in real time, and, of course, anonymously.
Is Europe lagging behind?
It is well known that, for many years, there have been major reservations in Europe about the collection and use of medical data. Whether justified or not, these concerns have significantly delayed the digitalization of our healthcare system. Consequently, electronic patient records, which also allow patients to "donate" their data, are being implemented far too late for fighting COVID-19 in Europe, and billing data from health insurance providers can still only be used with a considerable time delay (and only by a very small group of people – those performing public research). It will therefore be extremely challenging to set up a system for tracking the efficacy of COVID-19 vaccines on a wide scale within 2021. In order to still create such a system in a short time, the European Medicines Agency (EMA) will, in all likelihood, need to closely cooperate with privately owned companies such as medical software providers as well as data and analysis platforms.
Insights gained from the United States
A look at the U.S. shows how such a system can be set up. Due to different data protection requirements, conditions there are of course not fully comparable to those in the EU. However, it is also possible to collect anonymized patient data without patient "opt-ins" in Europe to produce statistics for the public good (Article 9, paragraph 2, lit. j GDPR). Although it is not possible to aggregate patient data to form patient histories across healthcare providers (this will always require the patient's consent), cross-sectional studies and generalized cohort studies can be carried out. If the legislature decides that in the future, anonymizing patient data without the patient's explicit consent will no longer be limited to certain exceptional circumstances, as is being discussed at the moment, this would open up more options.
The Americans are also able to act quickly when it comes to setting up a "COVID-19 real-word evidence platform" because the Federal Drug Agency (FDA) is closely cooperating with privately owned companies, including young, VC-funded start-ups such as Aetion and Health Verity. Furthermore, private nonprofit foundations such as the Reagan-Udall Foundation are organizing forums where universities, healthcare providers, and pharmaceutical companies discuss what crucial questions need to be answered and what data is required for this purpose.
Unlike Europe, where a strict distinction is made between private companies and public research when it comes to data access, the U.S. is thus taking a collaborative approach. This includes involving start-ups and private foundations besides pharmaceutical companies and even entrusting private companies with many coordination tasks. Coordination- and format-related issues are addressed dynamically while this system is already being set up, which further accelerates the process.
Together with the covidX initiative, which is supported by the EU, and in close cooperation with CompuGroup Medical SE, we are currently developing a concept of how a comparable system could be organized within the "European Health Data Space" and be made available by 2021. For more information on this initiative, see: www.covidx.eu/healthmirror.