Evaluating data is one of the most important tasks in medical research, yesterday as well as today. This is because researchers can learn from data how a particular disease progresses and which factors influence its course in order to derive, for example, a possible therapy. The size of the data set or the cohort under consideration plays an important role here. To put it simply, the more patients and their data can be used for the analysis, the more meaningful the result will be in the end. However, it is not possible to specify a minimum number of patients as a general rule. This must always be determined for the individual case, taking into account a variety of factors, such as the frequency of a disease. Before the researchers then start collecting data, the so-called feasibility analysis is an important next step. This allows an assessment of whether it is at all possible to answer the specific research question, for example in terms of the required and available human resources, the necessary financial resources and ultimately also the available patients and their medical data. Often, however, the number of patients treated at the researcher’s own site is not sufficient and patient data from other sites must also be used. Especially in the case of rare diseases, sufficiently high case numbers are naturally difficult to find. This is exactly where the MIRACUM research portal comes in and is intended to be the first point of contact for researchers when it comes to the question: who can contribute how many patients and what data to the required cohort and thus support the answer to the research question? Ultimately, the portal should guide researchers from the initial feasibility assessments to the ultimate submission of a data use request.
Using the portal should be as easy as possible, while maintaining data privacy and sovereignty. Accordingly, most of the functions can be used without prior authentication. Only the access to the central MIRACUM portal for data use applications is possible after logging in. There, concrete feasibility inquiries can be formulated as well as data usage requests can be submitted. Currently, all researchers at the 10 MIRACUM sites can gain access, initially upon request. Thanks to the Federated Authentication System (FAS), which has been established between the MIRACUM sites since the early days of the Medical Informatics Initiative (MII), researchers can then conveniently log into the portal using their usual, site-specific login credentials.
The MIRACUM research portal, accessible at https://www.miracum.org/en/miracum-forschungsportal/ currently offers the functionalities shown in Figure 1. These support the feasibility assessment by researchers in various aspects, which are briefly outlined below:
Helpful for an initial assessment of feasibility is in particular to answer the question whether a sufficiently large cohort of potentially matching patients is available at all. The MIRACUM datamap is intended to provide an initial overview by presenting various numbers aggregated across all sites. The presentation is based on the core data set modules of the MII, currently focused on the basic modules. Technically, the federated infrastructure of the MIRACUM-DIC is behind this, consisting of the Connector Component Federated Search (CC-FS), which is installed at each DIC and regularly transmits those aggregated numbers to the central broker.
2. Metadata Repository:
In addition to the number of potentially matching patients, the next step is to determine which data points are potentially available from all patients in a cohort. A look at the MIRACUM Metadata Repository (M-MDR) will help with this. Here, all data elements, that are basically available via the MIRACUM-DIC, are described in a common structured way, according to the generic metadata standard ISO 11179. This provides researchers with a great deal of helpful information for the specific formulation of feasibility queries and data use applications. The standardized and structured metadata can also be used by other software components via interfaces, e.g. for the future planned selection of data elements by click in the application form for a data use project.
3. Feasibility/Data Request/Project Proposal:
Using the central application portal ProSkive, researchers can first conduct a more in-depth feasibility query based on their initial findings through Datamap and M-MDR. To do this, they are redirected to a graphical query editor, currently built on the i2b2 data warehouse solution. Criteria selected from a catalog, retrieved in the background from M-MDR, can be assembled into a query using simple logical expressions. The query is then deployed via the central Federated Search Broker (FSB) within a federated infrastructure and all MIRACUM-DIC can download and execute it via the Connector Component Federated Search (CC-FS) and report the aggregated result back to the broker. This in turn returns the aggregate result, summarized over all answering sites, to the researchers. This process is completely automatic and the researchers receive the result after one to five minutes.
Based on this result, the researchers can then submit a data usage request or project proposal. During the review phase by the DIC, ethics committees, data protection officers and the use and access committees at the sites, the feasibility analysis can be further detailed in dialogue with the DIC, for example with regard to the need for additional prospective data collection. Based on this, and also on feedback from the local committees, the application may need to be sharpened and adjusted.
4. Project Registry/Data Use:
Medical research benefits from transparency and openness to collaboration, especially, for example, for patients with rare diseases, where it is naturally difficult to find sufficient patient numbers. In addition, patients themselves should be given the opportunity to see what happens to their data in research. To this end, all MIRACUM-wide data use applications are collected in a central registry, described, and important milestones are reported during their respective project duration. Currently, the registry is maintained manually; in the future, data will be automatically transferred from ProSkive.
5. Trial Registry:
To facilitate the search for suitable participants for studies, MIRACUM has established a central trial registry. All trials in which at least one of the MIRACUM sites is participating are listed there, including a description and inclusion and exclusion criteria. Since this information is, with FHIR, provided in a common structured and standardized format, it can also be used for the IT-supported participant recruitment as developed in MIRACUM as part of a use case. As a result, all patients currently undergoing treatment can be automatically checked overnight for their suitability for one of the trials and can then be proposed to the responsible study personnel for recruitment.
If you have general questions about the research portal, please feel free to contact the MIRACUM-Central Office (mailto:email@example.com). If you are a member of one of the MIRACUM sites and have questions about using the portal, please feel free to contact your local data integration center.