Metadata is about data and describes the nature of given information. Metadata can be any one of the following:
- Data about data – metadata, in other words, data about itself and its content.
- Data about the database – data that describes the database schema or structure.
- Data about the database management system (DBMS) – data that describes capabilities of the DBMS, such as performance and security features.
- Data about the users and their interaction with the database – data that describes how users are using the DBMS.
A metadata repository is a place where all this information is stored and managed to support decision making, business use cases, operations, and IT processes such as change management or database maintenance on a day-to-day basis. For example, a metadata repository can store all types of information such as trial design, protocol documents, study setup specific information like sites participating in the trial, study instruments used for collecting patient data, team leads for each study site, and so on. It is essential in various groups involved in clinical research, from study setup to monitoring to the analysis phase.
There are several benefits to using a repository, such as the ryze clinical metadata repository and similar ones for clinical studies, and this article will list some of them:
- Improves Efficiency
Researchers create, maintain, govern, and use standards consistently throughout their projects with a metadata repository in place. The repository can be configured to automatically generate standard reference documentation for each study. It improves efficiency because researchers spend less time creating documentation, manually populating spreadsheets, and responding to audit requests.
The repository also enables researchers to collaborate on projects since it can share information seamlessly. In addition, researchers can more easily perform critical tasks such as tracking changes made to the study design or identifying which internal and external parties will require data sets during the trial.
- Helps Researchers Reuse Existing Assets
The pharmaceutical industry is facing increased demands for speed and efficiency in the discovery, development, and approval of new drugs. Pharmaceutical companies are under the gun to bring more drugs to market faster. And once on the market, these companies must demonstrate that their products are safe and effective while maintaining federal regulations.
Many pharmaceuticals have started to use metadata repositories to help them store and extract data that they have used before to assist them in new projects.
For example, researchers working on developing a new treatment for women with breast cancer could use a metadata repository to access the thousands of clinical records that have already been collected through previous studies (with patient consent, of course). The researchers could then selectively review those records for specific characteristics that may be applicable to their research.
Additionally, if their study will focus on a specific ethnic group or patients at a certain age, they can review past studies for those same characteristics. They can also look for information about factors that may affect the effectiveness of the treatment they are developing, such as using other medications or patient lifestyle choices.
- Enhances Traceability
A metadata repository can benefit clinical studies by enabling researchers to improve traceability.
Traceability is the ability to trace a study back to its source and forward it to the destination, including how data is collected and validated, how it changes as it moves throughout the organization, and how information is used in real-time.
Data coming into an organization often comes from multiple sources — such as study site systems, laboratory data management systems, and more — and gets integrated into one or more platforms.
With all of these different methods to collect data comes several formats that are challenging to translate into a standard format. It can strain the research organization because they must manage multiple systems while maintaining data integrity.
Institutions that have already invested in an enterprise metadata repository (EMR) have found that their study data can be quickly mapped into another platform, allowing for a universal view of the data.
Once all the systems are connected through an EMR, it’s also possible for researchers to use artificial intelligence tools like machine learning or deep learning (a subset of machine learning) to develop predictive models that can identify specific outcomes from particular types of data.
- Helps In Creating Accurate Mappings
A metadata repository can benefit clinical studies by allowing researchers to create accurate mappings.
The mappings are subsequently used to extract data from the metadata repository to populate study-specific databases. By studying the relevant information to the project and making it available, a metadata repository will help you get an overview of your project environment and gain insight into how it works.
The information relevant to your project is also valuable to other projects, and they will be able to use the information you have made available from your metadata repository.
In other words, you can make the information available to others but still keep control over it.
The framework for clinical data sharing is here, and it will only get stronger. The future of clinical trials is bright now that metadata repositories can provide the foundation for unified access to clinical study data.