CENTRALIZED BIOMETRICS - The Backbone of a Global Clinical Data Strategy

INTRODUCTION

Clinical trial data can be overwhelming and quite challenging for sponsors and participants alike. With reams of data spread across disparate systems – and more information being accumulated every minute, every day – clinicians would be wise to remember that more data doesn’t always mean more insight. Sometimes more data is just that – more data.

So how do we control the management and delivery of this vast amount of data? 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 having 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.

The following will detail the steps needed to implement a successful global clinical data strategy and how to approach developing a centralized process that results in transparency, traceability, accuracy, and collaboration. Using one set of SOPs (standard operating procedures) and standard data formats will make it easier, more transparent, and more efficient in meeting the expectations of a regulatory body and/or the potential purchaser of a product license.

WHY IS CENTRALIZED BIOMETRICS THE BACKBONE OF A GLOBAL CLINICAL DATA STRATEGY?

Centralized biometrics is an alternative outsourcing approach that is appropriate for any size organization and may be especially helpful for small- and medium-size companies that are not heavily staffed to meet the challenges associated with managing the huge amount of data involved in a clinical trial. In the centralized biometrics model, sponsors keep clinical data functions – biostatistics and programming, data management, medical writing, and an EDC system – all with one specialized vendor. The main driver for implementing centralized biometrics is data standardization that promotes efficiencies and leads to cost savings, which is not found in other models.

There is no manual available describing just how to produce a global clinical data strategy; however, regulations and guidelines are forcing us in that direction. The EU clinical data transparency legislation is demanding that Sponsors produce traceable and transparent data, while the new ICH GCP E6 (R2) guidelines are forcing Sponsors to look at how they collect and report data. A centralized biometrics approach gets Sponsors moving in the direction of a coherent strategy. 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 thereby optimizing the journey from Phase 1 right through to post-marketing.

GETTING STARTED – EARLY IS BETTER

Without a doubt, a global clinical data strategy is complicated and highly complex, which obviously leads to the question – where and when to start? The short answer is the earlier the better. There will be a variety of teams associated with developing a global clinical data strategy, eg, 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 consistent study metrics and performance to measure data quality is also critical.

When thinking about developing a strategy, there are several 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 decision-making?
-Is our company prepared for clinical data transparency?
-Are we aware of the regulator’s recommendations for a risk-based monitoring approach and what does that mean?
-Have we considered the regulatory requirements that will factor into our strategy?

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, or a statistical programmer. Perspective differs depending on the function, and it’s often 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!

THE IMPACT OF ICH E6 (R2)

The intention of ICH E6 (R2) is to “provide increased clarity and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting.”

Fundamental to this is a risk-based approach to the Quality Management System and a risk-based approach to study conduct. The storage system (irrespective of the media used) should provide for document identification, search and retrieval. If subcontractors are to be used by CROs, then there will need to be clauses in contracts to take into account sub-contracted third-party agreements.

The Investigator should have control of and continuous access to the CRF (case report form) data reported to the Sponsor. Keep in mind that responsibility for any non-compliance issues falls under the Sponsor, and when an issue occurs, the Sponsor needs to perform a root cause analysis and corrective action.

All of these elements are more predictable and easier to handle when a centralized strategy is adopted and will reassure the regulatory agencies that due care and attention is being given to the handling of the data.

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 in which the message is understood and clearly defined. This ensures 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 create 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
-Create due-diligence ready data sets
-Comply with regulatory requirements and industry standards

An experienced, data-driven full-service CRO can provide a cost-effective and efficient centralized clinical data package by providing data management, statistical analysis, programming, and medical writing services coupled with excellent clinical project management, regulatory consultancy, and accompanying eClinical solutions.

This centralized biometrics approach, when applied appropriately, converts a mass of processes and data into a coherent, information-driven pathway from which the vision can be achieved and success is more certain.

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Paul Fardy is VP of Data Services for CROS NT (www.crosnt.com). He carries over 27 years of experience in biometrics team management with particular expertise in Clinical Data Management procedures and processes. Most of his career was spent in large pharmaceutical companies managing functional teams in Data Management, Statistics, Statistical Programming, and Medical Writing, where he recruited the necessary resources and developed metrics and resource planning for clinical studies. He also has experience in leading operations in the CRO sector prior to joining CROS NT and has earned a reputation for quickly developing productive, cohesive, and motivated teams. Mr. Fardy earned his degree in Microbiology from the University of Surrey and is based in the United Kingdom. He can be reached at: paul.fardy@crosnt.com.