WHITE PAPER

Unlock the Value of Clinical Data

Bring repeatability and automation to the data integration process with SAS Clinical Data Integration

UnloCk the ValUe of CliniCal Data

Table of Contents
Executive Summary .........................................................................................1 Introduction .....................................................................................................2 Improve Costs, Quality and Efficiency with Standards and Automation .......3 Driving Competitive Advantage for CROs and Biopharmaceuticals ..............4 CROs ............................................................................................................4 Pharmaceutical and Biotechnology Companies ..........................................5 Automating Data Integration and Standardization ........................................6 The Future of Standards ..................................................................................8 Closing Thoughts .............................................................................................8 About SAS ........................................................................................................9 A Closer Look .................................................................................................10

UnloCk the ValUe of CliniCal Data

Executive Summary
The life sciences industry is under pressure to accelerate time to market for new compounds at lower cost. A key to compressing the cycle is to streamline the data management tasks that consume as much as 65 percent of the clinical trial process, by some estimates. Traditionally, the process of managing clinical trials data has been cumbersome and resource-intensive. The data needed for analysis of drug safety and efficacy resides in multiple, disparate systems. Time-consuming and expensive manual coding is required to integrate all that data into analysis-ready form. Further data manipulations are required to prepare regulatory submissions. Every clinical trial brings a new data integration and transformation project, requiring just as much programming effort as the previous ones. There is much room for improvement in the traditional modus operandi by taking advantage of industry standards and automated data integration processes. Contract research organizations (CROs) can reduce the cost of their services while simultaneously growing revenues through new service offerings such as legacy data migration projects and Clinical Data Interchange Standards Consortium (CDISC) standards consulting. By efficiently standardizing legacy clinical data, pharmaceutical and biotechnology companies can unlock the scientific and business value hidden in their clinical repositories. In addition, these companies can leverage their standardized clinical data for more efficient and effective cross-study data analysis, review and utilization. With SAS Clinical Data Integration, clinical research professionals can improve efficiency, quality and speed in collecting, managing, analyzing, reporting and assessing data from clinical trials. Prebuilt models automatically transform legacy data to CDISC standards. Research analysts can readily customize the models using visual interfaces, create new ones and reuse the work of others. Embedded data quality routines ensure standard, trusted clinical data for analysis within and across clinical trials. Consistent, validated data structures enable timely, seamless flow of information among all the parties involved in a clinical trial. Industry analysts have stated that automated data integration and validation can trim 30 to 50 percent from the clinical trial cycle. Field experience with the SAS solution has shown that even greater savings are possible. This white paper makes a case for implementing data standards and applying automated processes for managing data throughout the clinical trials process, from study design to regulatory submissions.

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Introduction
Does the experience of this life sciences executive match the current reality in your organization? We also had a number of disparate systems holding various pieces of information and they didnt talk to each other, and we were actually incapable of having the information at our fingertips The workflow of clinical trials depends on multiple, complex data interactions that may occur across multiple organizations. Information collected from study subjects is deposited into a clinical repository, painstakingly transformed to suit study purposes, analyzed to determine product efficacy and safety, and then used to prepare the regulatory submission. By some estimates, as much as 65 percent of the time it takes to conduct a clinical trial is spent on data interchange among collaborating entities. The process entails a series of exchanges between sponsors and investigators, between sponsors and CROs, between CROs and labs, between sponsors and regulators, and so on. The growing volume and complexity of these data interactions is seen as a primary cause for escalating costs in drug development. The ideal of converging on a set of data standards such as those from CDISC to streamline collaboration is gaining momentum but facing three key obstacles as well:

1. Collaborating organizations rarely have compatible systems.

In many cases, the parties involved in the process of bringing a drug to market do not share a common corporate data network, electronic data capture tool, clinical data repository, statistical computing environment or clinical reporting system. Key clinical information is scattered across disparate IT systems or platforms that use different data definitions and formats. This inconsistent data must be aggregated and transformed before it can be used for meaningful analysis.

Clinical study data is typically

scattered among multiple clinical systems and stored in multiple formats across multiple operating environments and organizations.

2. Data transformation processes tend to be highly manual.

In many cases, data preparation is treated as a unique project for each clinical study. Time-intensive manual coding and processes are required to prepare data for analysis. These processes are run protocol by protocol, often edited and updated to reflect the unique nature of the study, and then executed many times as data is updated over the course of the trial. And dont forget the dramatic schedule impact of last-minute changes identified by the project team.

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This highly manual approach is not repeatable across studies, nor does this process scale without adding expensive headcount. The company misses opportunities to reuse processes, code and information. As a result, more programmers are needed to support additional studies. And still there is the risk of data corruption from coding errors and inconsistencies.

Inefficiencies in the collection

and preparation of clinical data for analysis can slow the pace of drug development and dramatically increase the cost of bringing a new drug to market.

3. Standards are not necessarily seen as a top priority.

For one, they are not required yet. The US Food and Drug Administration (FDA) has recommended the submission of clinical data in CDISC SDTM (Study Data Tabulation Model) format, but has not mandated the use of standards. Within the life sciences industry, conversations about standards are generally moving from a discussion of what and why to how and when. But, when faced with competing priorities, is the implementation of standards truly a top priority within most life sciences organizations? Some may argue that with limited programmer resources high-priority drug development projects must take precedence over some possible future requirement. Some organizations would assert that they can perform business activities faster using their own unique processes and data formats. Internally, that may be true, but since so much clinical trial activity is collaborative outside the organization, unique processes and data formats hinder the overall flow of the process.

Improve Costs, Quality and Efficiency with Standards and Automation

Agreement on data standards enables seamless information flow through the entire pre-clinical and clinical research process, from protocol design to various sources for data collection, data management, analysis and reporting, regulatory submission and electronic data archive. CDISC standards such as SDTM, Analysis Data Model (ADaM) and Operational Data Model (ODM) support interoperability among all participants in the clinical trial process. First available in 2001, CDISC standards were initially slow to be adopted but are now gaining momentum. The business case is compelling. One study concluded that adopting standards could simplify data aggregation and reduce rework by 35-40 percent and increase overall efficiency of study startup, analysis and reporting by 30 percent. The study concluded that those who fail to adopt standards and appropriate automation tools will take 30 to 50 percent longer to complete clinical trials.

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The potential for cost savings is enough to make the most tradition-bound organization take notice. Consider a single clinical trial with an eight-month cycle time (excluding subject participation time) and an average daily study cost of $37,000 per day (an estimate developed by Tufts Center for Drug Development). The reduction in cycle time would yield $9 million in cost savings for a typical trial $15.7 million per submission for a trial on the critical path. In addition, the adoption of standards with automated clinical data integration would improve the quality of clinical research by: Decreasing startup and reporting time for clinical trials. Improving communications among project teams. Reducing the chance of human error in data management processes. Preserving knowledge from prior studies in a reusable fashion. Enabling investigators to analyze adverse events and trends across a series of trials.

CDISC standards implemented at the beginning of a clinical study can reap savings of 70-90 percent of the startup stage time and cost, for an overall study resource savings of 60 percent (outside of the subject participation time). The resulting efficiencies would allow the industry as a whole to save billions of dollars and also to concentrate on developing products that meet escalating safety, public health and regulatory requirements.
Statement from the Clinical Data Interchange Standards Consortium

Driving Competitive Advantage for CROs and Biopharmaceuticals

Delivering true competitive advantage is a difficult task in todays life sciences market. Using SAS Clinical Data Integration, many SAS customers are enjoying the benefits of competitive advantage derived from lower costs, higher revenues and better market awareness.

CROs
In order to remain competitive, CROs must deliver their services faster, better and cheaper than both competing CROs and the sponsors own internal departments. This is a major challenge for even the most efficient organizations. There is tremendous potential for CROs to extract significant competitive advantage from both a cost and revenue standpoint using SAS Clinical Data Integration. Major cost savings are possible for the delivery of analytic services based on efficient standardization and automation during analytical data preparation. More importantly, CROs have the opportunity to grow revenue through more competitive bids and the development of new service offerings to win legacy data migration projects and consulting projects.

CROs can extract significant

competitive advantage from both a cost and revenue perspective using SAS Clinical Data Integration.

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Pharmaceutical and Biotechnology Companies

Most pharmaceutical and biotechnology companies have a wealth of existing clinical trial data that is a largely ignored, yet invaluable corporate asset. Standard clinical data can easily be used to derive additional value by reducing the number of new trials, identifying new indications or marketing claims for a compound, or designing more efficient study protocols. SAS Clinical Data Integration can efficiently standardize these clinical information assets at a lower cost than existing practices. Once a repository of historical standard clinical data has been developed, pharmaceutical and biotechnology companies can unlock the significant scientific and business value hidden in their clinical data assets. The possibilities for driving competitive advantage are significant: Identify new comparative effectiveness signals that uncover new revenue opportunities through the identification of previously unknown advantages over competitor therapies. Leverage existing data to make new marketing claims or uncover potential new indications. Improve trial design and planning. Automate the cross-study integration effort to derive value from existing data assets with reduced cost and improved data quality. Speed data preparation for medical publications. Ease the integration effort from M&A and licensing deals by automating migration for acquired data assets through data standards. For current clinical research programs, SAS Clinical Data Integration can efficiently prepare and validate SDTM data for submission, speed timelines for analysis and reporting by standardizing in-process data and support the exploration of data across trials for business and scientific value.

Pharmaceutical and biotechnical

companies can easily automate cross-study integration efforts, reducing cost and increasing quality to derive value from existing clinical data assets.

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Automating Data Integration and Standardization

SAS Clinical Data Integration brings repeatability and automation to the processes associated with creating analysis-ready data. Clinical research professionals now have an easy-to-use visual interface for transforming, managing and verifying the creation of standard data, for CDISC or other standards. The solution provides the essential capabilities in four key areas: Aggregating data from multiple sources. Mapping disparate data to a uniform, consistent data structure. Cleansing the data to ensure a trustworthy basis for analysis. Validating the transformation of data to CDISC or internal standards. Data aggregation brings together clinical study data that is scattered among multiple clinical systems and stored in multiple formats across multiple operating environments and organizations. Typical data sources include laboratory data, EDC data, IVRS data, patient diary data, pre-clinical data, CDMS data and CTMS data among others. SAS Clinical Data Integration can access all of this data regardless of the source and format. Data mapping transforms clinical data to standard data (such as CDISC SDTM), transforms operational data to analysis data sets, or combines data from multiple studies to support cross-study data analysis. Automated data transformation processes replace the inefficient, costly manual coding used for most data mapping efforts today. The SAS solution has prebuilt transformations for CDISC models; those transformation routines can be extended and customized as needed. Data transformations are designed in easy-to-use visual interfaces using standard SAS Data Integration Studio functionality. Through metadata, the solution documents a full mapping of data source (where the data came from), data manipulations (how the data has been altered) and the final destination for data. Impact analysis reports clarify the impact of any change to the process, such as changes to incoming data formats, data standards or additional data required for analysis data sets. Data preparation processes cleanse the data to deliver consistent, trusted and verifiable clinical information. Embedded data quality routines eliminate the problems of inaccurate, contradictory and inconsistent data. With an accurate, real-time view of clinical information, you can address potential issues before they affect a study. Plus, you can understand your compound faster through more frequent interim analysis of high-quality data.

The ability to provide fast, efficient

access to clinical data, regardless of the location or source, is becoming a critical capability for organizations to improve time to market and contain clinical research costs.

Build and document data

transformations with a user-friendly GUI interface. Data transformations are easy to explain to get new team members up to speed quickly and easy to reuse, to reduce the need to write unique code for each study.

SAS Clinical Data Integration

provides an accurate real-time view of clinical information through the application of automated data quality and data transformation routines.

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Data standardization and validation automates the process of validating CDISC standards and/or an organizations internal data standards. The solution is flexible enough to map to different standards, such as different versions of SDTM or custom standards as required by a specific therapeutic area, development program or organizational entity. SAS Clinical Data Integration can evolve to support emerging and future health care data standards, with lifecycle management for standards as they evolve.

Visually convert legacy data to

standard data validating both data structure and content for conformance to CDISC and/or internal standards while ensuring proper use of standards.

Metadata The Power Behind Automated, Repeatable Clinical Data Integration

The automated capabilities described in this paper are made possible by metadata data about data. Metadata records and tracks the sources, transformations, uses and destinations of data. With shared metadata, clinical data integration becomes a repeatable, auditable and automatic process. Suppose you get a request to rerun a data transformation, perhaps because an SDTM model or its source data was updated, or there was a suspected error in the process. Without metadata, you would have to look at every piece of the puzzle to determine what actually needs to be done to address the situation. The detective work might have to span many transformations. For example, if the request is being driven by a new demography data set, you would need to manually find every place where that demography data set has been used. In contrast, a metadata-driven process automatically identifies what parts of the process need to be rerun and then runs them.

A largely hands-off, automated approach reduces workload but also makes the next project extremely straightforward. You already have a working model for many or even all of the data transformations that might be required. Simply update the data source references (one small subset of metadata) and go. Each subsequent project can build on the previous ones, each project being in turn less resource-intensive and more efficient than the previous ones. With SAS Clinical Data Integration, you can build data transformation processes to standardize legacy and other disparate data to CDISC models, customize the embedded CDISC models and create new models to match your organizations business requirements. In the process, you ensure the proper use of CDISC or custom standards, deliver cleaner data for analysis and submissions, while decreasing costs and time to submission.

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The Future of Standards

SAS maintains a strong commitment to the development and implementation of data standards in the health sciences industry. As a CDISC member since 2000, SAS has been a leader in the development of vital data standards for the life sciences industry. SAS is making certain that our products and solutions support the implementation of key CDISC models. Data standards for the health sciences will continue to evolve and the importance of both HL7 and CDISC standards will increase. Future breakthrough health care discoveries will be powered by simplifying access to key health care information through the power of industry data standards. In order to take full advantage of constantly evolving industry standards, your organization requires software that both supports and easily incorporates new standards. You can rest assured that SAS has a strong track record for supporting key industry data standards within SAS software both now and in the future.

Closing Thoughts
In an industry being reshaped by mega-mergers and acquisitions, regulation and globalization, commoditization and competition, every day counts. Every dollar counts. Every resource counts. Pharmaceutical companies must seize every opportunity to compress the clinical trial cycle. Automating the data aggregation, transformation and validation tasks associated with analytical data preparation for clinical trials can potentially trim significant time and costs from the clinical trials process. The SAS Clinical Data Integration solution provides value for sponsors, CROs and regulatory authorities through mature data transformation capabilities, embedded CDISC capabilities, the ability to automate repeatable processes and the flexibility to support the evolution of both new and custom models. One SAS customer, a leading CRO, significantly reduced the time required to standardize data to SDTM. What used to take a week can now be finished in a morning, in just 6 percent of the time formerly required. The organization estimates that efficiency gains will yield cost savings of between $2 million and $2.3 million in three years, plus an estimated $3 million in new revenues due to having SAS Clinical Data Integration as a competitive differentiator in the CRO market.

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Time and cost savings as compelling as they are are only part of the story: Prebuilt and customizable data transformations ensure the proper use of standards, especially CDISC. Embedded data quality routines deliver cleaner, more trustworthy data. Automated processes dramatically reduce the time required to manage and report on clinical data. Common metadata makes data processes repeatable, auditable and automatic. Standardized data fosters greater communication among project teams and across projects thereby improving the quality of scientific discovery. To find out more about SAS Clinical Data Integration and other SAS solutions for life sciences organizations, contact your SAS account representative or visit www.sas.com/industry/pharma.

About SAS
SAS is the leader in business analytics software and services, and the largest independent vendor in the business intelligence market. Through innovative solutions delivered within an integrated framework, SAS helps customers at more than 45,000 sites improve performance and deliver value by making better decisions faster. Since 1976, SAS has been giving customers around the world THE POWER TO KNOW.

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A Closer Look

Figure 1. Design data flow and transformations in a visual interface with specific clinical data functionality.

Figure 2. Detailed reports describe data standards usage patterns. These reports can be used to determine the impact of changes to an existing standard or version changes like migrating from SDTM 3.1.1 to SDTM 3.1.2.

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Figure 3. Status reports about mapping and adherence to a standard are also available either by study or for all active studies.

Figure 4. Administrators can add, remove and modify industry data standards and internal data standards, as well as manage clinical studies including standards use, default content for new studies and controlled terminology packages.

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