Description
Utilizing The Sas Business Intelligence Platform In A Clinical Trial Environment
Business Analytics – Clinical
An Experis IT Technical Brief
Utilizing the SAS
Business Intelligence
Platform in a Clinical
Trial Environment
Brian Varney & Mindy Kiss, Experis IT
Portage, Michigan
1 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
Abstract
Clinical trial environments are rampant with similar tasks being performed over
and over again on similar data. The past two decades have seen substantial
standardization of data storage and reporting, and as a result the time is right
to leverage business intelligence software to maximize the value of these vast
warehouses of clinical data. The SAS Business Intelligence platform is a logical
path to take because of the easy integration with existing SAS programs and data
sources that are already proven and familiar. This will also allow non-traditional SAS
users such as statisticians, study monitors, biologists and data managers to access
the data without the use of traditional SAS code.
It should be noted that the optimal SAS product for clinical trial projects is SAS
Drug Development (SDD). This paper is intended to present an alternative to using
only the traditional SAS modules in a clinical trial environment. This is especially
useful for companies needing to perform ad-hoc analysis and reporting on their
data outside of formal submissions such as validating results from a CRO.
Introduction
This paper intends to accomplish the following:
1. Map clinical user groups to BI platform roles and tools.
2. Identify the components of the SAS Business Intelligence Platform and how
they ?t into the clinical trial process.
3. Provide a brief demonstration of integrating existing SAS Clinical Code into a
SAS BI Platform and exploiting it from the different reporting and analysis tools.
4. Outline the value that the SAS Business Intelligence Platform brings to a
company that has to analyze and report on clinical data.
a. Reduce bottlenecks in gaining knowledge from clinical data.
b. Widen the audience of users that have direct access to data.
c. Allow developers and programmers to focus on building robust data
architectures and facilitating data access rather than creating, running and
distributing ad-hoc reports/queries.
Concepts
Groups and Roles
The primary value realized when using the SAS BI platform is the empowerment of
users to extract their own information from the data, while eliminating dependencies
on designers and administrators. The designer and administrator groups should be
focusing on improving application and data architecture rather than responding to
report and analysis requests.
When considering a business intelligence tool purchase and implementation, it is
important to assess your current user base and document their preferences and
needs. Having these types of details gathered and documented will be bene?cial
during the implementation and training portion of the platform roll out.
2 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
Table 1 below maps typical business intelligence roles to typical clinical study roles.
Depending on the experience and background of the clinical team at your company,
this may need to be modi?ed for your site.
Table 1. Clinical Roles Mapped to BI Roles
BI Role Tool Clinical Role
Administrator
• SAS Management Console
• IT Administrator
• SAS Administrator
Developer/Power User
• SAS Management Console
• SAS Enterprise Guide
• SAS Stored Processes
• SAS Information Map Studio
• Data Architect
• Data Integrator
• SAS Application Developer
• SAS Programmer
• Statistician
Consumer
• SAS Add-in for Microsoft Of?ce
• SAS Web Report Studio
• SAS Information Delivery Portal
• Data Manager
• Investigator/Monitor
• Medical Writer
• Director or Manager of Biostatistics
SAS Business Intelligence Platform Components
• SAS Management Console – The SAS Management Console allows IT and SAS
administrators to implement and monitor the SAS BI Platform and appropriate
security settings to the SAS BI environment.
• SAS Enterprise Guide – SAS Enterprise Guide is a user-friendly graphical user
interface to the SAS programming language. Users can use project palettes to
browse, analyze and report on data. Users can also convert their project to a
stored process very easily to share with other information consumers.
• SAS Stored Processes – SAS Stored Processes are essentially SAS programs
which have a wrapper on them. This wrapper consists of a few lines of code at the
beginning and end of the program. If the program is a macro, the parameters can
be easily set up as parameters automatically presented in a graphical user interface.
• SAS Information Map Studio – Information Map Studio allows clinical data set
designers to map physical data structures to business data structures and de?nitions
that are ready for analysis and reporting. Information consumers and analysts can use
this data without having to know the physical attributes of the data.
• SAS Add-in for Microsoft Of?ce (AMO) – The SAS Add-in for Microsoft
Of?ce allows users already familiar with Microsoft Of?ce products to browse,
analyze and report on data. Users can even run existing SAS programs (stored
processes) from Excel, Word, PowerPoint or Outlook.
• SAS Web Report Studio – SAS Web Report Studio is a thin-client reporting tool.
Information consumers only need a Web browser on their client machines to be
able to browse and report on data. Users can build reports that consist of tables,
listings, graphs and stored processes. These reports can then be made public or
kept in the user’s private folder.
3 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
• SAS Information Delivery Portal – The SAS Information Delivery Portal provides
a common front end for clinical trial information. Think of it as the clinical Yahoo
or Google with users able to customize their own “home pages,” as well as have
access to pages shared by the designers.
• SAS BI Dashboard – (special portlet within the SAS Information Delivery
Portal) The SAS BI Dashboard enables users to monitor their key measures in a
dashboard format. SAS BI Dashboards are created, maintained and viewed via
the Information Delivery Portal. Some examples of key measures that could be
tracked on a SAS BI Dashboard are # of data discrepancies (failed edits), # of
patients enrolled or at a certain point(visit) in each study, percentage of types of
adverse events experienced per drug arm, etc.
Figure 2 outlines a typical clinical data management process. While of course
these can vary slightly based on the type of study or company involved, it is fairly
representative. By using the SAS BI platform, the following areas of the above
process ?ow can be accomplished more ef?ciently.
Data Processing, Cleaning, Discrepancy Management, Coding
Relational database tables can be registered as libraries in the SAS Management
Console. This will enable the developers and power users to make the data available
to the information consumers in such a way that the consumers don’t need to
know the physical attributes of the data or how the data is joined together. The
data architects, data integrators and SAS programmers design and implement a
consistent, ef?cient structure so there are not unnecessary copies of data all over the
servers or desktops. Many inef?cient queries can also be avoided because only the
team members that are experts with the data architecture and the SAS BI platform
are controlling the query construction.
Figure 2. Overlaying the SAS Business Intelligence Tools onto a
Typical Clinical Study Process
Enrollment LPLV
QA
Lock,
Archive
Analysis &
Reporting
Database
Snapshot/
Transfer to
Stats
QC
STUDY
Protocol
Procedures
Database
Development
Protocol Review &
CRF Development
Data Processing,
Cleaning, Discrepancy
Management, Coding
4 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
The members of the developer/power user team can also design “canned”
reports to demonstrate data consistency and cleanliness. Although the information
consumers will be able to design their own discrepancy checks, many of the
standard ones can be wrapped up in one or more SAS stored processes or
designed as SAS Web Report Studio reports.
Quality Assurance (QA)
Using the SAS BI platform will reduce the manual effort required for producing
discrepancy management reports as well as custom data queries. The clinical data is
available to the information consumers via SAS Web Report Studio, the SAS Add-in
for Microsoft Of?ce or Enterprise Guide. The choice of tool(s) for surfacing reports and
queries will depend on user preference and connection into the network. For example,
a company may only want their investigators and study monitors to use a Web browser.
When the architecture and tools allow information consumers to access their own
data without understanding how to code queries or join tables together, they can
focus on reviewing and cleansing the data.
Analysis and Reporting
Using the SAS BI platform for clinical analysis and reporting can result in the similar
bene?ts as the QA effort. Running existing reports and/or creating new reports can
be accomplished via a Web browser or through thicker clients such as Enterprise
Guide or Microsoft Of?ce products. All queries that are supporting reports and
analysis are controlled by the SAS Metadata server so consistency is achieved for
background processing.
Conclusion
As one can see, there are many advantages to utilizing the SAS Business
Intelligence Platform in a clinical environment. One signi?cant bene?t realized is the
ability for non-developers to access information and make decisions without having
to request the time of a programmer/analyst or data architect. In addition, existing
SAS Macros can easily be converted to stored processes which can be run from
MS Of?ce or Internet Explorer, thus leveraging the code already in place.
References
• SAS BI Administrator and Usage Documentation
• Society for Clinical Trials 2007 “Essentials of Clinical Data Management”
Acknowledgements
We would like to take this time to thank everyone we have worked with
and learned from in our exciting clinical SAS adventures.
Contact Information
Your comments and
questions are valued and
encouraged. The authors
may be contacted at:
Brian Varney, Experis IT
Mindy Kiss, Experis IT
5278 Lovers Lane
Portage, Michigan 49002
(800) 831-6314
SAS and all other SAS
Institute Inc. product
or service names are
registered trademarks or
trademarks of SAS Institute
Inc. in the USA and other
countries. ® indicates
USA registration. Other
brand and product names
are trademarks of their
respective companies.
About Experis
Experis
TM
is the global leader in professional resourcing and project-based
workforce solutions. We accelerate organizations’ growth by intensely attracting,
assessing and placing specialized expertise in IT, Finance & Accounting and
Engineering to precisely deliver in-demand talent for mission-critical positions,
enhancing the competitiveness of the organizations and people we serve.
experis.com
Experis IT
Experis IT delivers the people, processes, infrastructure and technologies that
organizations need to effectively align IT with business objectives. We help clients
meet business and cost containment objectives through contract and permanent
IT professional resourcing, as well as project solutions for discrete, mission-critical
initiatives — always providing the expertise and tools necessary to maximize
productivity and create competitive advantage.
experis.com
About ManpowerGroup
ManpowerGroup
TM
(NYSE: MAN), the world leader in innovative workforce
solutions, creates and delivers high-impact solutions that enable our clients
to achieve their business goals and enhance their competitiveness. With over
60 years of experience, our $19 billion company creates unique time to value
through a suite of innovative solutions that help clients win in the Human Age.
These solutions cover an entire range of talent-driven needs from recruitment and
assessment, training and development, and career management, to outsourcing
and workforce consulting. ManpowerGroup maintains the world’s largest and
industry-leading network of nearly 3,900 of?ces in over 80 countries and territories,
generating a dynamic mix of an unmatched global footprint with valuable insight
and local expertise to meet the needs of its 400,000 clients per year, across all
industry sectors, small and medium-sized enterprises, local, multinational and
global companies. The ManpowerGroup suite of solutions is offered through
ManpowerGroup Solutions, Experis,
TM
Manpower
®
and Right Management
®
.
manpowergroup.com
doc_751190437.pdf
Utilizing The Sas Business Intelligence Platform In A Clinical Trial Environment
Business Analytics – Clinical
An Experis IT Technical Brief
Utilizing the SAS
Business Intelligence
Platform in a Clinical
Trial Environment
Brian Varney & Mindy Kiss, Experis IT
Portage, Michigan
1 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
Abstract
Clinical trial environments are rampant with similar tasks being performed over
and over again on similar data. The past two decades have seen substantial
standardization of data storage and reporting, and as a result the time is right
to leverage business intelligence software to maximize the value of these vast
warehouses of clinical data. The SAS Business Intelligence platform is a logical
path to take because of the easy integration with existing SAS programs and data
sources that are already proven and familiar. This will also allow non-traditional SAS
users such as statisticians, study monitors, biologists and data managers to access
the data without the use of traditional SAS code.
It should be noted that the optimal SAS product for clinical trial projects is SAS
Drug Development (SDD). This paper is intended to present an alternative to using
only the traditional SAS modules in a clinical trial environment. This is especially
useful for companies needing to perform ad-hoc analysis and reporting on their
data outside of formal submissions such as validating results from a CRO.
Introduction
This paper intends to accomplish the following:
1. Map clinical user groups to BI platform roles and tools.
2. Identify the components of the SAS Business Intelligence Platform and how
they ?t into the clinical trial process.
3. Provide a brief demonstration of integrating existing SAS Clinical Code into a
SAS BI Platform and exploiting it from the different reporting and analysis tools.
4. Outline the value that the SAS Business Intelligence Platform brings to a
company that has to analyze and report on clinical data.
a. Reduce bottlenecks in gaining knowledge from clinical data.
b. Widen the audience of users that have direct access to data.
c. Allow developers and programmers to focus on building robust data
architectures and facilitating data access rather than creating, running and
distributing ad-hoc reports/queries.
Concepts
Groups and Roles
The primary value realized when using the SAS BI platform is the empowerment of
users to extract their own information from the data, while eliminating dependencies
on designers and administrators. The designer and administrator groups should be
focusing on improving application and data architecture rather than responding to
report and analysis requests.
When considering a business intelligence tool purchase and implementation, it is
important to assess your current user base and document their preferences and
needs. Having these types of details gathered and documented will be bene?cial
during the implementation and training portion of the platform roll out.
2 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
Table 1 below maps typical business intelligence roles to typical clinical study roles.
Depending on the experience and background of the clinical team at your company,
this may need to be modi?ed for your site.
Table 1. Clinical Roles Mapped to BI Roles
BI Role Tool Clinical Role
Administrator
• SAS Management Console
• IT Administrator
• SAS Administrator
Developer/Power User
• SAS Management Console
• SAS Enterprise Guide
• SAS Stored Processes
• SAS Information Map Studio
• Data Architect
• Data Integrator
• SAS Application Developer
• SAS Programmer
• Statistician
Consumer
• SAS Add-in for Microsoft Of?ce
• SAS Web Report Studio
• SAS Information Delivery Portal
• Data Manager
• Investigator/Monitor
• Medical Writer
• Director or Manager of Biostatistics
SAS Business Intelligence Platform Components
• SAS Management Console – The SAS Management Console allows IT and SAS
administrators to implement and monitor the SAS BI Platform and appropriate
security settings to the SAS BI environment.
• SAS Enterprise Guide – SAS Enterprise Guide is a user-friendly graphical user
interface to the SAS programming language. Users can use project palettes to
browse, analyze and report on data. Users can also convert their project to a
stored process very easily to share with other information consumers.
• SAS Stored Processes – SAS Stored Processes are essentially SAS programs
which have a wrapper on them. This wrapper consists of a few lines of code at the
beginning and end of the program. If the program is a macro, the parameters can
be easily set up as parameters automatically presented in a graphical user interface.
• SAS Information Map Studio – Information Map Studio allows clinical data set
designers to map physical data structures to business data structures and de?nitions
that are ready for analysis and reporting. Information consumers and analysts can use
this data without having to know the physical attributes of the data.
• SAS Add-in for Microsoft Of?ce (AMO) – The SAS Add-in for Microsoft
Of?ce allows users already familiar with Microsoft Of?ce products to browse,
analyze and report on data. Users can even run existing SAS programs (stored
processes) from Excel, Word, PowerPoint or Outlook.
• SAS Web Report Studio – SAS Web Report Studio is a thin-client reporting tool.
Information consumers only need a Web browser on their client machines to be
able to browse and report on data. Users can build reports that consist of tables,
listings, graphs and stored processes. These reports can then be made public or
kept in the user’s private folder.
3 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
• SAS Information Delivery Portal – The SAS Information Delivery Portal provides
a common front end for clinical trial information. Think of it as the clinical Yahoo
or Google with users able to customize their own “home pages,” as well as have
access to pages shared by the designers.
• SAS BI Dashboard – (special portlet within the SAS Information Delivery
Portal) The SAS BI Dashboard enables users to monitor their key measures in a
dashboard format. SAS BI Dashboards are created, maintained and viewed via
the Information Delivery Portal. Some examples of key measures that could be
tracked on a SAS BI Dashboard are # of data discrepancies (failed edits), # of
patients enrolled or at a certain point(visit) in each study, percentage of types of
adverse events experienced per drug arm, etc.
Figure 2 outlines a typical clinical data management process. While of course
these can vary slightly based on the type of study or company involved, it is fairly
representative. By using the SAS BI platform, the following areas of the above
process ?ow can be accomplished more ef?ciently.
Data Processing, Cleaning, Discrepancy Management, Coding
Relational database tables can be registered as libraries in the SAS Management
Console. This will enable the developers and power users to make the data available
to the information consumers in such a way that the consumers don’t need to
know the physical attributes of the data or how the data is joined together. The
data architects, data integrators and SAS programmers design and implement a
consistent, ef?cient structure so there are not unnecessary copies of data all over the
servers or desktops. Many inef?cient queries can also be avoided because only the
team members that are experts with the data architecture and the SAS BI platform
are controlling the query construction.
Figure 2. Overlaying the SAS Business Intelligence Tools onto a
Typical Clinical Study Process
Enrollment LPLV
QA
Lock,
Archive
Analysis &
Reporting
Database
Snapshot/
Transfer to
Stats
QC
STUDY
Protocol
Procedures
Database
Development
Protocol Review &
CRF Development
Data Processing,
Cleaning, Discrepancy
Management, Coding
4 | Utilizing the SAS Business Intelligence Platform in a Clinical Trial Environment
The members of the developer/power user team can also design “canned”
reports to demonstrate data consistency and cleanliness. Although the information
consumers will be able to design their own discrepancy checks, many of the
standard ones can be wrapped up in one or more SAS stored processes or
designed as SAS Web Report Studio reports.
Quality Assurance (QA)
Using the SAS BI platform will reduce the manual effort required for producing
discrepancy management reports as well as custom data queries. The clinical data is
available to the information consumers via SAS Web Report Studio, the SAS Add-in
for Microsoft Of?ce or Enterprise Guide. The choice of tool(s) for surfacing reports and
queries will depend on user preference and connection into the network. For example,
a company may only want their investigators and study monitors to use a Web browser.
When the architecture and tools allow information consumers to access their own
data without understanding how to code queries or join tables together, they can
focus on reviewing and cleansing the data.
Analysis and Reporting
Using the SAS BI platform for clinical analysis and reporting can result in the similar
bene?ts as the QA effort. Running existing reports and/or creating new reports can
be accomplished via a Web browser or through thicker clients such as Enterprise
Guide or Microsoft Of?ce products. All queries that are supporting reports and
analysis are controlled by the SAS Metadata server so consistency is achieved for
background processing.
Conclusion
As one can see, there are many advantages to utilizing the SAS Business
Intelligence Platform in a clinical environment. One signi?cant bene?t realized is the
ability for non-developers to access information and make decisions without having
to request the time of a programmer/analyst or data architect. In addition, existing
SAS Macros can easily be converted to stored processes which can be run from
MS Of?ce or Internet Explorer, thus leveraging the code already in place.
References
• SAS BI Administrator and Usage Documentation
• Society for Clinical Trials 2007 “Essentials of Clinical Data Management”
Acknowledgements
We would like to take this time to thank everyone we have worked with
and learned from in our exciting clinical SAS adventures.
Contact Information
Your comments and
questions are valued and
encouraged. The authors
may be contacted at:
Brian Varney, Experis IT
Mindy Kiss, Experis IT
5278 Lovers Lane
Portage, Michigan 49002
(800) 831-6314
SAS and all other SAS
Institute Inc. product
or service names are
registered trademarks or
trademarks of SAS Institute
Inc. in the USA and other
countries. ® indicates
USA registration. Other
brand and product names
are trademarks of their
respective companies.
About Experis
Experis
TM
is the global leader in professional resourcing and project-based
workforce solutions. We accelerate organizations’ growth by intensely attracting,
assessing and placing specialized expertise in IT, Finance & Accounting and
Engineering to precisely deliver in-demand talent for mission-critical positions,
enhancing the competitiveness of the organizations and people we serve.
experis.com
Experis IT
Experis IT delivers the people, processes, infrastructure and technologies that
organizations need to effectively align IT with business objectives. We help clients
meet business and cost containment objectives through contract and permanent
IT professional resourcing, as well as project solutions for discrete, mission-critical
initiatives — always providing the expertise and tools necessary to maximize
productivity and create competitive advantage.
experis.com
About ManpowerGroup
ManpowerGroup
TM
(NYSE: MAN), the world leader in innovative workforce
solutions, creates and delivers high-impact solutions that enable our clients
to achieve their business goals and enhance their competitiveness. With over
60 years of experience, our $19 billion company creates unique time to value
through a suite of innovative solutions that help clients win in the Human Age.
These solutions cover an entire range of talent-driven needs from recruitment and
assessment, training and development, and career management, to outsourcing
and workforce consulting. ManpowerGroup maintains the world’s largest and
industry-leading network of nearly 3,900 of?ces in over 80 countries and territories,
generating a dynamic mix of an unmatched global footprint with valuable insight
and local expertise to meet the needs of its 400,000 clients per year, across all
industry sectors, small and medium-sized enterprises, local, multinational and
global companies. The ManpowerGroup suite of solutions is offered through
ManpowerGroup Solutions, Experis,
TM
Manpower
®
and Right Management
®
.
manpowergroup.com
doc_751190437.pdf