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Developing, Managing, and Evaluating a Standard Macro System

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 .

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Developing, Managing, and Evaluating a Standard Macro System

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  1. Developing, Managing, and Evaluating a Standard Macro System Albert Mo Biometrics XOMA, LLC Berkeley, CA

  2. Agenda • Introduction • Definition of SMS • Creation & Evolution of SMS • Developing SMS • Managing SMS • Evaluating SMS • Challenges & Opportunities • Conclusion • Q & A

  3. 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

  4. Creation & Evolution of SMS

  5. 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

  6. Benefits of SMS 1. Improved productivity Improved Productivity!!! Fewer Customized Programs More Standardized Programs +

  7. 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!!!

  8. 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

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.)

  14. 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.

  15. 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

  16. 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.

  17. Q & A

  18. Contact informationAlbert Momo@xoma.com

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