slide1 n.
Download
Skip this Video
Loading SlideShow in 5 Seconds..
Developing, Managing, and Evaluating a Standard Macro System PowerPoint Presentation
Download Presentation
Developing, Managing, and Evaluating a Standard Macro System

Loading in 2 Seconds...

play fullscreen
1 / 18

Developing, Managing, and Evaluating a Standard Macro System - PowerPoint PPT Presentation


  • 189 Views
  • Uploaded on

Developing, Managing, and Evaluating a Standard Macro System. Albert Mo Biometrics XOMA, LLC Berkeley, CA. Agenda. Introduction Definition of SMS Creation & Evolution of SMS Developing SMS Managing SMS Evaluating SMS Challenges & Opportunities Conclusion Q & A .

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'Developing, Managing, and Evaluating a Standard Macro System' - Leo


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
slide1

Developing, Managing, and Evaluating a Standard Macro System

Albert Mo

Biometrics

XOMA, LLC

Berkeley, CA

agenda
Agenda
  • Introduction
  • Definition of SMS
  • Creation & Evolution of SMS
  • Developing SMS
  • Managing SMS
  • Evaluating SMS
  • Challenges & Opportunities
  • Conclusion
  • Q & A
introduction definition
Introduction & Definition

What is a Standard Macro System?

  • Globally developed
  • Fully integrated
  • Centrally managed

What is NOT a Standard Macro System?

  • Standard Macro Libraries
  • Project (TA) level macros
structure of sms

End-user Macros:

%demog_table(…);

High-level Utility Macros:

%setup(colvar=treat, …);

%contsum(var=age, …);

%catsum(var=sex, …);

%catsum(var=race, …);

%print(…);

Analysis

Data Sets

(demog)

Application Program

(t_demog.sas)

%demog_table

(…);

TLG

(t_demog.pdf)

Low-level Utility Macros:

%printset(…);

%pageset(…);

%nobs( …);

%wordcnt(…);

%chkparm(…);

Figure 1. SMS System Flowchart

Structure of SMS
benefits of sms 1 improved productivity
Benefits of SMS 1. Improved productivity

Improved

Productivity!!!

Fewer

Customized

Programs

More

Standardized

Programs

+

benefits of sms 2 savings from centralized effort
Benefits of SMS2. Savings from Centralized effort

Centralized team effort in:

  • Developing
  • Supporting
  • Training

Savings:

  • Developed once!
  • Tested once!
  • Validated once!
  • Re-used again and again!!!
benefits of sms 3 company wide standardization

CRFs

Input

Analysis

Data Sets

SMS

Output

TLGs

CSRs

Clinical

Database

Data sets

Site

Investigators

(External)

Clinical Data Management (CDM)

Statistical Programming

Biostatistics &

Other Clinical

Operations

Figure 2. SMS Stakeholders and their Roles with SMS

Benefits of SMS3. Company-wide standardization
developing sms
Developing SMS
  • Assemble a SMS team
  • Establish coding standard
  • Think globally, yet work locally
  • Guarantee backward-compatibility
  • Respect users’ working environment
  • Apply Software Development Life Cycle (SDLC)
software development life cycle sdlc

User

Needs

User

Requirements

Implementation

User Acceptance

Test

User

Community

Analysis

Unit

Testing

Design

Coding

Figure 3. Software Development Life Cycle (SDLC)

Software Development Life Cycle (SDLC)
managing sms
Managing SMS
  • Secure upper management’s support and commitment
  • Provide proper leadership to the SMS team
  • Establish a steering committee
  • Organize a SMS User Group (SMSUG)
  • Establish 24/7 technical support
  • Conduct regular training & education sessions (eHandbook)
evaluating sms critical success factors csfs
Evaluating SMS- Critical Success Factors (CSFs)
  • Management support
  • Error-free confidence and reliability
  • Robustness and flexibility
  • Quick response
  • Continuous improvement
  • Continuous education & training
  • Continuous promotion (raising awareness)
challenges complexity stemmed from having many stakeholders
Challenges- Complexity stemmed from having many stakeholders
  • All input data(empty data sets, existence of data sets/variables, missing values, zero divisions, large sizes, etc.)
  • All customers(statistical programmers, biostatisticians, clinicians, clinical data managers, drug safety, medical writing, and other clinical operations personnel, etc.)
  • All statistical methods(PROC FREQ, PROC NPAR1WAY, PROC GLM, PROC LIFETEST, PROC LIFEREG, etc.)
  • All tables(missing columns, missing cells, empty columns/cells, etc.)
  • All output(styles, margins, formats, titles/footnotes, “No Report Generated”, etc.)
challenges concerns about job security
Challenges- Concerns about job security
  • Fears:
    • “Now that we have SMS, I will no longer be needed, or have a job…”
  • Focus on:
    • Creation of analysis data sets
    • Validation of application programs
    • Project planning/management
    • Participation of SMS development and testing
    • Development of other selective customized TLG programs: There is an 80-20 rule: 80% of TLGs can be generated by SMS, while 20% of TLGs still need to be created with customized programs.
opportunities
Opportunities
  • Emergent trends of company-wide standardization:
    • Standard CRF modules
    • Standard Analysis Dataset (ADS) Specification
    • Standard Statistical Analysis Plan (SAP) templates
    • Standard CSR templates
    • SOPs and other Operational Guides
  • Emergent trend of industry-wide standardization:
    • CDISC (Clinical Data Interchange Standards Consortium) standard
conclusion
Conclusion
  • SMS is probably the biggest investment in Biostatistics operation. But it will pay off.
  • Our ultimate goal of “A new TLG is just another standard macro call away!” is closer to becoming a reality.