There is no manual available describing just how to produce a global clinical data strategy. However, a centralized biometrics approach can provide an opportunity to do just that. It can also help to deliver a rich repository of disparate data from multiple sources that is verifiable, traceable and meets complex regulatory requirements. This can avoid delay and expense optimizing the journey from Phase 1 right through to post-marketing.
Getting Started – Early is Better
There’s no argument that a global clinical data strategy is complicated and highly complex which leads to the question – where do we start? The answer is the earlier the better. There will be a number of teams associated with developing a global clinical data strategy, e.g. clinical development and regulatory marketing teams, external teams, third party vendors, labs, all of the entities that provide different niche deliverables need to be onboard.
Continuity between the biometrics team and the sponsor is essential to design a template that includes better integration of studies across all phases with common assessment methods and data standards. There needs to be agreement on the traceability of data and one set of operating procedures. Agreement on centralization of study metrics and performance is also critical as is the use and re-use of global libraries – which elevates efficiencies and may lead to significant cost reductions.
When thinking about developing a strategy, there are a number of questions to ask:
- Is the data our greatest asset?
- What’s our outsourcing strategy?
- How can we best utilize our data and make sense of it to assure appropriate decisions?
- Is our company prepared for clinical data transparency?
- And, are we aware of the regulator’s recommendations for a risk-based monitoring approach and what does that mean?
These are topics that have come up in our experience and have different definitions depending on where you sit. You can be a program manager, a data manager, a statistical programmer etc. . Perspective differs depending on your function and often it’s difficult to have an overarching vision and understanding of where you need to be and how to get there. It’s complicated and complex to be sure!
Corporate Governance Committee: Keys to a Successful Global Strategy
Designing and implementing a global standards governance committee serves as the foundation for both standardization and centralization of clinical trial data. With the variety of different standards implicit in the many disparate documents involved in a trial, compounded by the fact that each have their own individual standards applied to them, it’s important to identify, create and utilize global, cross-therapeutic and therapeutic standards within the entire clinical development process.
Also important is the centralization of study metrics and reporting. Centralization creates a platform where the message is understood and clearly defined. This assures the validity of the data and provides an understanding of exactly what the data is “saying” and can be understood and clearly defined. While this is a difficult task with separate sources it’s much easier when the data is centralized. And, even better, there is a cost-reduction element. The centralization approach means that through re-usage and efficiencies of process those reductions should be immediately realized.
Steps to Implementing a Global Clinical Data Strategy
In short, a CRO with deep experience in leading sponsors to develop a global clinical data strategy will help with a path to:
- Design and implement a global standards governance committee
- Identify, create and utilize global cross-therapeutic and therapeutic standards
- Institutionalize and harmonize standards within the clinical development process
- Creating due-diligence ready data sets
This process will result in transparency and traceability and collaboration that will make it easier and more efficient to meet the expectations of a regulatory body and/or the potential purchaser of a product license.