2 0 1 1 FA L L B I O M E T R I C S W E B I N A R S E R I E S    Streamlining Data Management Start-upNov. 15, 2011 Present...
Cheryl Silva                                         Associate Director, Technical Operations                            ...
Today’s Topics3     ▪ Need for Streamlined Approach     ▪ Areas for Efficiencies        – Standards        – Parallel appr...
Need for Streamlined Approach                                  In 2003, health economists in the US estimated the average ...
Need for Streamlined Approach                                  In 2003, health economists in the US estimated the average ...
Need for Streamlined Approach2011 FALL BIOMETRICS WEBINAR SERIES
2005 Survey     Factors that Could Best Prevent Future Delays7                                 % “Best Prevent Future Dela...
Electronic Data Capture8                                           Medidata Rave…                                         ...
2009 Survey     Factors that Could Best Prevent Future Delays9                                 % “Best Prevent Future Dela...
Streamlining Study Start-up10      Without a streamlined study start-up process, the      following efficiencies gained th...
Efficiencies                Standards                Parallel Approach                Identifying Key Reviewers        ...
Standards12      ▪ Standard CRFs      ▪ Global Library objects      ▪ Standard Data Validation Plan (DVP) pre-populated   ...
Parallel Approach13              Identify tasks that can be performed in parallel                                         ...
Key Pieces to Parallel Approach14                 Resource                  Managing                                      ...
Parallel Approach15      Perform Parallel Reviews     2011 FALL BIOMETRICS WEBINAR SERIES
Parallel Approach16      Perform Parallel Reviews     2011 FALL BIOMETRICS WEBINAR SERIES
Identifying Key Reviewers17      Identify key reviewers based on:      1) Deliverable            – Edit check specificatio...
One size does not fit all18      Different types of trials have different study start-up needs                            ...
Premier Express19      Premise:      ▪ Process designed to meet the needs of small phase 1        pharmaceutical and devic...
Case Study20                                              DATA MANAGEMENT                                           45 da...
Case Study21                                           Phase 1 Single Center Pain Trial                     Number of Site...
Case Study22                                              DATA MANAGEMENT                                           45 da...
Case Study23                                     Mock eCRF Development                                               13 d...
Case Study24                                              DATA MANAGEMENT                                           36 da...
Case Study25                                     Annotated Case Report Form (aCRF)                                11 days...
Case Study26                                              DATA MANAGEMENT                                           28 da...
Case Study27        STANDARD                     Database Development                                             8 days ...
Case Study28                                              DATA MANAGEMENT                                           27 da...
Case Study29        STANDARD                     Edit Check Programming                                            13 day...
Case Study30                                              DATA MANAGEMENT                                           25 da...
Summary                Time benefits gained from the use of EDC can                 only be realized when an efficient DM...
Upcoming Webinars32      Register at www.premier-research.com/webinars      ▪ Strategies for Implementing CDISC        13 ...
Questions?             Cheryl Silva             Associate Director, Technical Operations             234 Copeland Street  ...
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Streamlining Data Management Start-up

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This webinar, led by Cheryl Silva, introduced a solution for streamlining study start-up activities and tailoring the scope of these activities to coincide with studies of varying complexity. In addition, the challenges driven by tight trial timelines for the data management team was reviewed.

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Streamlining Data Management Start-up

  1. 1. 2 0 1 1 FA L L B I O M E T R I C S W E B I N A R S E R I E S Streamlining Data Management Start-upNov. 15, 2011 Presented by Cheryl Silva
  2. 2. Cheryl Silva  Associate Director, Technical Operations  Expertise in: – CRF design – Database development – Application support – Electronic data handling – Report programming  Programming/software development background  Bachelor’s degree in Computer and Information Science from the University of Massachusetts2011 FALL BIOMETRICS WEBINAR SERIES
  3. 3. Today’s Topics3 ▪ Need for Streamlined Approach ▪ Areas for Efficiencies – Standards – Parallel approach – Identifying key reviewers – One size doesn’t fit all ▪ Summary 2011 FALL BIOMETRICS WEBINAR SERIES
  4. 4. Need for Streamlined Approach In 2003, health economists in the US estimated the average cost of bringing a drug to market at US$802 million. Today, those Drug Approvals – From costs are forecasted in the range of $1.3 to - $1.7 billion. Clinical trials cost is one of the biggest expense categories for Invention to Market… biopharmaceutical companies. The Industry Challenge:Year Trip A 12- • More than 80% of clinical trials experience delay from one to six months costing pharmaceutical companies upwards of $35,000 per day, per trial. • Only 10% of trials are completed on time.2011 FALL BIOMETRICS WEBINAR SERIES
  5. 5. Need for Streamlined Approach In 2003, health economists in the US estimated the average cost of bringing a drug to market at US$802 million. Today, those costs are forecasted in the range of $1.3 to - $1.7 billion. Clinical trials cost is one of the biggest expense categories for biopharmaceutical companies. The Industry Challenge: • More than 80% of clinical trials experience delay from one to six months costing pharmaceutical companies upwards of $35,000 per day, per trial. • Only 10% of trials are completed on time.2011 FALL BIOMETRICS WEBINAR SERIES
  6. 6. Need for Streamlined Approach2011 FALL BIOMETRICS WEBINAR SERIES
  7. 7. 2005 Survey Factors that Could Best Prevent Future Delays7 % “Best Prevent Future Delays” 50% 45% 42% 40% 37% 35% 34% 30% 20% 10% 0% EDC Fewer More Money Standardized Sites Involved Technologies Intermediaries for Patient CRFs Earlier in the Recruitment Protocol Process Source: CenterWatch Survey of Investigative Sites in the U.S., 2005 (n=612) Multiple responses offered 2011 FALL BIOMETRICS WEBINAR SERIES
  8. 8. Electronic Data Capture8 Medidata Rave… Improving efficiency of study build and life cycle management Electronic Data Capture (EDC)… expedite time-to-market 2011 FALL BIOMETRICS WEBINAR SERIES
  9. 9. 2009 Survey Factors that Could Best Prevent Future Delays9 % “Best Prevent Future Delays” 50% 40% 31% 30% 29% 30% 27% 26% 20% 10% 0% Fewer Streamlined EDC More Money Standardized Intermediaries Contracting Technologies for Patient CRFs and Budgeting Recruitment Source: CenterWatch Survey of Investigative Sites in the U.S., 2009 (n=950) Multiple responses offered 2011 FALL BIOMETRICS WEBINAR SERIES
  10. 10. Streamlining Study Start-up10 Without a streamlined study start-up process, the following efficiencies gained through the use of EDC are diminished:  Real time data entry/data availability  Real time data cleaning 2011 FALL BIOMETRICS WEBINAR SERIES
  11. 11. Efficiencies  Standards  Parallel Approach  Identifying Key Reviewers  One size does not fit all – Premier Express2011 FALL BIOMETRICS WEBINAR SERIES
  12. 12. Standards12 ▪ Standard CRFs ▪ Global Library objects ▪ Standard Data Validation Plan (DVP) pre-populated with Standard edit checks ▪ Different companies maintain different Standards – Premier Research follows Clinical Data Acquisition Standards Harmonization (CDASH) industry standards ▪ Important: Agreeing to Standards up front saves time 2011 FALL BIOMETRICS WEBINAR SERIES
  13. 13. Parallel Approach13 Identify tasks that can be performed in parallel Edit Check Edit Check Start DVP Programming Testing Identify CRFs Live Database from Standards Start Database Database Study Training Build Testing Data Manager Data Programmer 2011 FALL BIOMETRICS WEBINAR SERIES
  14. 14. Key Pieces to Parallel Approach14 Resource Managing Standard Allocation and Timeline Timelines Management Shifts 2011 FALL BIOMETRICS WEBINAR SERIES
  15. 15. Parallel Approach15 Perform Parallel Reviews 2011 FALL BIOMETRICS WEBINAR SERIES
  16. 16. Parallel Approach16 Perform Parallel Reviews 2011 FALL BIOMETRICS WEBINAR SERIES
  17. 17. Identifying Key Reviewers17 Identify key reviewers based on: 1) Deliverable – Edit check specification will not necessarily have the same reviewers as Data Entry Guidelines – Create a table of deliverables and identify reviewers & approvers Deliverable Reviewers/Approvers Data Management Plan Project Manager, Lead Data Manager Edit Check Specifications Lead Data Manager, Database Developer Batch Data Load Specifications Database Developer, Clinical Programmer Dataset Listings Lead Data Manager, Clinical Programmer 2) Role – Example: Chief Operating Officer does not need to review CRFs – Example: CRA does not need to review dataset specifications 2011 FALL BIOMETRICS WEBINAR SERIES
  18. 18. One size does not fit all18 Different types of trials have different study start-up needs Phase 3 Phase 1 Global Multicenter Single Center Oncology Trial Pain Trial Number of Sites 258 1 Number of Subjects 1200 48 Duration 3.5 years 4 months Number of CRF page 60 unique pages 24 unique pages 2011 FALL BIOMETRICS WEBINAR SERIES
  19. 19. Premier Express19 Premise: ▪ Process designed to meet the needs of small phase 1 pharmaceutical and device studies ▪ Timelines for these studies are short Key components: ▪ Standard data collection pages ▪ Don’t need to collect and subsequently analyze more data than necessary – Standard single module edit checks – Limited sponsor reviews of key documents to expedite execution of trial 2011 FALL BIOMETRICS WEBINAR SERIES
  20. 20. Case Study20  DATA MANAGEMENT 45 days  Mock eCRF Development 13 days STANDARD 9 WEEK TIMELINE Mock eCRF Development & Internal Review 6 days Sponsor v1.0 Review and Comments Provided 3 days 13 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 1 day Sponsor v2.0 Review and Comments Provided 2 days Mock eCRF v2.0 Updated Based on Sponsor Comments 1 day Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 11 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 3 days 11 days for aCRF development aCRF Updates Based on Sponsor Comments 1 day Sponsor v2.0 Review Comments Provided 3 days aCRF Updates Based on Sponsor Comments 1 day Approval Annotated CRF 0 days  Database Development 8 days Database Developed 2 days 8 days for database development Database QC & DM Testing 4 days Data Entry Screens Tested by Sponsor (UAT) – optional 2 days Database Activation 0 days  Edit Check Programming 13 days Edit Checks Programmed 5 days 13 days for edit check development Data Management Testing 8 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  21. 21. Case Study21 Phase 1 Single Center Pain Trial Number of Sites 1 Number of Subjects 48 Duration 4 months Number of CRF page 24 unique pages  Goal: database and edit checks activated within 5 weeks  Plan: 1) Use existing Premier Research CDASH Standard CRFs 2) Sponsor waived their review of CRFs and annotated CRFs 3) Limit internal CRFs and annotated CRFs reviews to relevant parties and implement review meetings to streamline communication 4) Execute activities in parallel 2011 FALL BIOMETRICS WEBINAR SERIES
  22. 22. Case Study22  DATA MANAGEMENT 45 days  Mock eCRF Development 13 days ACCELERATED 5 WEEK TIMELINE Mock eCRF Development & Internal Review 6 days Sponsor v1.0 Review and Comments Provided 3 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 1 day Sponsor v2.0 Review and Comments Provided 2 days Mock eCRF v2.0 Updated Based on Sponsor Comments 1 day Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 11 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 3 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 1 day Sponsor v2.0 Review Comments Provided 3 days aCRF Updates Based on Sponsor Comments 1 day Approval Annotated CRF 0 days  Database Development 8 days Database Developed 2 days 7 days for database development Database QC & DM Testing 4 days Data Entry Screens Tested by Sponsor (UAT) – optional 2 days Database Activation 0 days  Edit Check Programming 13 days Edit Checks Programmed 5 days 11 days for edit check development Data Management Testing 8 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  23. 23. Case Study23  Mock eCRF Development 13 days STANDARD Mock eCRF Development & Internal Review 6 days Sponsor v1.0 Review and Comments Provided 3 days 13 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 1 day Sponsor v2.0 Review and Comments Provided 2 days Mock eCRF v2.0 Updated Based on Sponsor Comments 1 day Sponsor Approval 0 days Initial eCRF development and review reduced from 6 to 4 days by copying eCRFs Premier Research’s standard pages. Sponsor leveraged Premier Research CDASH and study start-up expertise regarding the look/feel of the data entry pages and the alignment of the data collection requirements with the protocol.  Mock eCRF Development 13 days 4 ACCELERATED Mock eCRF Development & Internal Review 6 days 4 Sponsor v1.0 Review and Comments Provided 0 3 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 0 days 1 day Sponsor v2.0 Review and Comments Provided 0 2 days Mock eCRF v2.0 Updated Based on Sponsor Comments 0 days 1 day Sponsor Approval 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  24. 24. Case Study24  DATA MANAGEMENT 36 days  Mock eCRF Development 4 days ACCELERATED 5 WEEK TIMELINE Mock eCRF Development & Internal Review 4 days Sponsor v1.0 Review and Comments Provided 0 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 0 days Sponsor v2.0 Review and Comments Provided 0 days Mock eCRF v2.0 Updated Based on Sponsor Comments 0 days Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 11 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 3 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 1 day Sponsor v2.0 Review Comments Provided 3 days aCRF Updates Based on Sponsor Comments 1 day Approval Annotated CRF 0 days  Database Development 8 days Database Developed 2 days 7 days for database development Database QC & DM Testing 4 days Data Entry Screens Tested by Sponsor (UAT) – optional 2 days Database Activation 0 days  Edit Check Programming 13 days Edit Checks Programmed 5 days 11 days for edit check development Data Management Testing 8 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  25. 25. Case Study25  Annotated Case Report Form (aCRF) 11 days STANDARD aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 3 days 11 days for aCRF development aCRF Updates Based on Sponsor Comments 1 day Sponsor v2.0 Review Comments Provided 3 days aCRF Updates Based on Sponsor Comments 1 day Approval Annotated CRF 0 days Initial aCRF development and review remains the same since aCRF generation is usually standard. Sponsor leveraged Premier Research CDASH and start-up expertise regarding the names of the database objects.  Annotated Case Report Form (aCRF) 11 days 3 ACCELERATED aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 0 3 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 0 days 1 day Sponsor v2.0 Review Comments Provided 0 3 days aCRF Updates Based on Sponsor Comments 0 days 1 day Approval Annotated CRF 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  26. 26. Case Study26  DATA MANAGEMENT 28 days  Mock eCRF Development 4 days ACCELERATED 5 WEEK TIMELINE Mock eCRF Development & Internal Review 4 days Sponsor v1.0 Review and Comments Provided 0 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 0 days Sponsor v2.0 Review and Comments Provided 0 days Mock eCRF v2.0 Updated Based on Sponsor Comments 0 days Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 3 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 0 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 0 days Sponsor v2.0 Review Comments Provided 0 days aCRF Updates Based on Sponsor Comments 0 days Approval Annotated CRF 0 days  Database Development 8 days Database Developed 2 days 7 days for database development Database QC & DM Testing 4 days Data Entry Screens Tested by Sponsor (UAT) – optional 2 days Database Activation 0 days  Edit Check Programming 13 days Edit Checks Programmed 5 days 11 days for edit check development Data Management Testing 8 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  27. 27. Case Study27 STANDARD  Database Development 8 days Database Developed 2 days 8 days for Database QC & DM Testing 4 days database Data Entry Screens Tested by Sponsor (UAT) – optional 2 days development Database Activation 0 days Because Standard CRF are used, database objects may be copied in from Standard Global Library. This reduces initial development and QC time by 1 day. Sponsor UAT testing increases from 2 to 3 days because this is the first time sponsor is seeing data entry screens. ACCELERATED  Database Development 8 days 7 Database Developed 21days day 7 days for Database QC & DM Testing 4 days 3 database Data Entry Screens Tested by Sponsor (UAT) – optional 2 days 3 development Database Activation 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  28. 28. Case Study28  DATA MANAGEMENT 27 days  Mock eCRF Development 4 days ACCELERATED 5 WEEK TIMELINE Mock eCRF Development & Internal Review 4 days Sponsor v1.0 Review and Comments Provided 0 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 0 days Sponsor v2.0 Review and Comments Provided 0 days Mock eCRF v2.0 Updated Based on Sponsor Comments 0 days Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 3 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 0 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 0 days Sponsor v2.0 Review Comments Provided 0 days aCRF Updates Based on Sponsor Comments 0 days Approval Annotated CRF 0 days  Database Development 7 days Database Developed 1 day 7 days for database development Database QC & DM Testing 3 days Data Entry Screens Tested by Sponsor (UAT) – optional 3 days Database Activation 0 days  Edit Check Programming 13 days Edit Checks Programmed 5 days 11 days for edit check development Data Management Testing 8 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  29. 29. Case Study29 STANDARD  Edit Check Programming 13 days Edit Checks Programmed 5 days 13 days for Data Management Testing 8 days database Edit Checks Activated 0 days development Because Standard database objects are used, edit checks may be copied in from Standard Global Library. This reduces initial development and QC time by 1 day. Note: The example used in this case study required more edit checks than usual because of the complicated enrollment criteria. Typically, the use of Premier Express would nearly eliminate all programming time. ACCELERATED  Edit Check Programming 13 days 11 Edit Checks Programmed 5 days 4 11 days for Data Management Testing 8 days 7 database Edit Checks Activated 0 days development 2011 FALL BIOMETRICS WEBINAR SERIES
  30. 30. Case Study30  DATA MANAGEMENT 25 days  Mock eCRF Development 4 days ACCELERATED 5 WEEK TIMELINE Mock eCRF Development & Internal Review 4 days Sponsor v1.0 Review and Comments Provided 0 days 4 days for CRF development Mock eCRF v1.0 Updated Based on Sponsor Comments 0 days Sponsor v2.0 Review and Comments Provided 0 days Mock eCRF v2.0 Updated Based on Sponsor Comments 0 days Sponsor Approval 0 days  Annotated Case Report Form (aCRF) 3 days aCRF Development & Internal Review 3 days Sponsor v1.0 Review Comments Provided 0 days 3 days for aCRF development aCRF Updates Based on Sponsor Comments 0 days Sponsor v2.0 Review Comments Provided 0 days aCRF Updates Based on Sponsor Comments 0 days Approval Annotated CRF 0 days  Database Development 7 days Database Developed 1 day 7 days for database development Database QC & DM Testing 3 days Data Entry Screens Tested by Sponsor (UAT) – optional 3 days Database Activation 0 days  Edit Check Programming 11 days Edit Checks Programmed 4 days 11 days for edit check development Data Management Testing 7 days Edit Checks Activated 0 days 2011 FALL BIOMETRICS WEBINAR SERIES
  31. 31. Summary  Time benefits gained from the use of EDC can only be realized when an efficient DM approach is used  Efficiencies in study start-up can be gained through the use of standards, advanced planning, and tailoring the process to meet the project needs2011 FALL BIOMETRICS WEBINAR SERIES
  32. 32. Upcoming Webinars32 Register at www.premier-research.com/webinars ▪ Strategies for Implementing CDISC 13 December at11:00 am EST Speaker: Thomas Kalfas Listen to past webinars: ▪ The Role of Data Monitoring Committees Speaker: Ron Kershner, Ph.D. ▪ IVR/IWR…More than just Randomization Speaker: Ryan Michaud 2011 FALL BIOMETRICS WEBINAR SERIES
  33. 33. Questions? Cheryl Silva Associate Director, Technical Operations 234 Copeland Street Quincy, MA 02169 Telephone: 617.237.1120 cheryl.silva@premier-research.com2011 FALL BIOMETRICS WEBINAR SERIES

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