臨床メタデータリポジトリに期待すべき役割とは？

When clinical trial metadata is not managed efficiently, it can be unreliable, inconsistent, and outdated. Typically, metadata is stored over multiple locations, and is non-standardized. It can be difficult to find the correct forms to use, or the latest, approved internal standards to adhere to when collecting data. A clinical metadata repository can help overcome these problems.

A clinical metadata repository is a ‘single source of truth’: a centralized, reliable library of metadata assets such as forms, terminologies and datasets that are ready to use and reuse when you need them. By implementing a comprehensive clinical metadata repository, organizations can streamline their metadata management, improve submission data quality, get earlier data insights, and accelerate new drugs to market.

The term ‘metadata’ in clinical trials refers to the content that forms the building blocks of your clinical study, for example forms, annotations, terminologies, datasets, mapping and files. Metadata is ‘data that describes data’. An example of metadata within a dataset would be a ‘variable’. A ‘variable’ describes a particular measurement (e.g. height, age, weight) and how it should be recorded. It will allow for a range of possible measurement values within the data itself. The metadata is a description of the data (e.g. is it numeric or text, what are the possible values?) while the data is the chosen value.

• Better data quality

A key benefit to using a clinical metadata repository is the ability to improve data quality. By standardizing the way you collect clinical data up front (before any data is actually collected), you can ensure that you collect the right data, in the right format, giving you confidence that your submission to the regulator will be successful.

• Earlier decision making

By having access to standardized metadata from the get-go, healthcare professionals can easily access and retrieve relevant clinical data for research, analysis, and reporting purposes. They can make crucial decisions about the safety and efficacy of a drug more quickly, ultimately improving patient outcomes.

• Easier collaboration

Efficient metadata management plays a crucial role in the process of drug discovery. With the increasing volume and complexity of clinical trial data, it is essential to have a centralized repository that enables you to share, reuse and standardize metadata. Standardization of metadata in clinical trials ensures consistency and accuracy in data interpretation, enabling easier collaboration among different stakeholders. It also allows you to compare data for different studies more easily.

It’s not enough to simply find a clinical metadata repository and implement it. Different platforms have different capabilities, and not every offering will meet your requirements or enable you to maximize your clinical metadata management.

If the platform you’re looking at doesn’t meet some basic specifications, you could be wasting your time and money. So, what should you expect when it comes to choosing a clinical metadata repository?

The following functionalities really are a ‘no-brainer’. A clinical metadata repository should as a minimum:

• Give you easy access to CDISC-compliant templates to make study build faster and easier CDISC compliant
• Stay up to date with new versions of the standards, and support older versions
• Let you reuse your standards
• Have versioning in place
• Have built-in traceability
• Let you find your metadata easily and quickly

Beyond the list above, there are some additional features that could really make a difference to the performance of your clinical trials. We’ve identified four additional considerations for building successful clinical trials.

It’s really important to understand how content is used in your clinical trials. A metadata repository should provide clear visibility of:

• where your metadata is used
• how it’s used
• how often it’s used
• the impact of changing it (I know you mention this below but I think it should still be in the list

That way, when you have lots of change requests, you can easily see which ones you need to focus on.

If the content needs to be changed, you need to be able to see what the impact of those changes will be, so you can decide the appropriate way forward. For example, perhaps you’re thinking of making a change to a standard that’s used in many studies. Implementing this change will mean making lots of changes to lots of studies. That’s quite a bit of work that’ll take considerable time and resources. So, you need to know if making the change is worth it.

Do the benefits of making the change outweigh the work and resources needed to make it happen? If the answer is ‘yes’, then it’s worth making the change. That’s why it’s important that your metadata repository gives you the visibility to see the impact of that change before you make the change.

Metadata needs to be governed to ensure it doesn’t become out of date or invalid. Neglected metadata can lead to poor quality or incorrect data collection or processing. Plus, it probably doesn’t meet the needs of the stakeholders involved. Your metadata, then, needs to be subject to a governance lifecycle.

Data governance refers to the processes and policies that govern the management, quality, and security of clinical data. It includes establishing data standards, defining data ownership and stewardship, and implementing data access controls. Effective data governance ensures that the clinical metadata repository is maintained and utilized in a consistent and secure manner.

Here’s a simple example of a governance lifecycle:

Governance is one of the most important features of a metadata repository. It helps you:

• Improve data quality
• Control and understand the workflow of content

• Assess the impact of change
• Develop robust organizational standards

With good governance, you can trust your metadata is accurate. And if your metadata is accurate, your data will be accurate too.

If you can see the detailed lifecycle of a standard, there’s total transparency in your team, and you’ll avoid regulatory non-compliance.

Collaboration allows a team of people, regardless of their role or location, to work together easily. For example, a group of people with different roles maintaining a set of global standards need to be able to collaborate on those standards without worrying about poor document control or complex approvals processes.

From Data Managers to Biostatisticians, each person involved in clinical trial build brings their own set of requirements. A clinical metadata repository should accommodate the needs of each role while ensuring data transparency and robust processes. That way, stakeholders can easily see the impact of other people’s changes, communication is clear, and there’s less room for misinterpretation. The end result is a better experience for all users. You get much more consistent, higher quality data, faster.

A metadata repository should be at the centre of your clinical trial build. It should work with other systems and databases to make your whole organization more efficient and increase data quality.

Every clinical trial is different. For example, you might have to use different electronic data capture (EDC) systems for different studies, or even for different phases of one study. Having the ability to design studies and standards with specific EDC systems in mind, and the freedom to use multiple systems if required, makes building clinical trials much easier.

A clinical metadata repository with EDC integration lets you fully design your Case Report Forms (CRFs), including complex tasks like edit checks and conditions. You can see what your forms look like upfront, before you upload it to the EDC. You can carry out a simple review and approval process and you can generate specifications for review outside the system. Once you’re happy with your CRFs, you can automatically build your EDC system, which saves time and money by removing manual interpretation of your specs. Overall, your studies will be higher quality and more consistent.

You should also consider whether you need other systems to be able to pull metadata from your chosen metadata repository, and push data to it. If your metadata repository has an API, your other systems can talk to it and make it the central hub for knowledge in your organization.