Enhancing the CRO-Sponsor Collaboration to Ensure High Quality of Clinical Data. Charles Yan, PhD. Shanghai Clinical Research Center

Transcription

1 Enhancing the CRO-Sponsor Collaboration to Ensure High Quality of Clinical Data May 17,2011 Beijing, China Charles Yan, PhD Shanghai Clinical Research Center

2 Agenda Potential Advantages and Risks for Outsourcing Outsourcing for Clinical Data Management Considerations in Selecting a CRO Key Factors for High Data Quality Best Outsourcing Relationship 2

3 Potential Advantages for CROs Reduce: Time to develop and commercialize a new drug Sponsor s fixed costs with personnel, equipment and facilities needed for its clinical development Provide: Ready access to needed expertise and/or technology Greater access to potential investigators Knowledge of regulatory climate in foreign markets 3

4 Potential Risks of Outsourcing to CROs Reduced control of the clinical trial process by the Sponsor Delays in completion of studies Lost or poor data quality Regulatory infractions produce indirect consequences FDA regulations/gcps Fraud and Abuse IP 4

5 Outsourcing for Clinical Data Management Data Management Plan CRF Design, Annotated CRF Database Setup and Edit Check Development Data Entry and Discrepancy Management Lab Data Management AE/SAE Management Coding (MedDRA + WHO DD) Database Locking QC and QA Electronic Data Capture Site User Training, Administration and Support EDC: Site Guides 5

6 Considerations in Selecting a CRO Company information Historical overview of the organization, Length of time in the industry, Financial stability of the organization Organizational structure Products and services Experience Product demonstration Commercial Business sustainability Cost of services 6

7 Considerations in Selecting a CRO Compliance Understanding of global regulations(fda, SFDA, etc) Archiving system Quality systems and proof of compliance to their quality requirements Quality assurance Documentation of system validation for regulated processes Evaluation of the vendor s QC/QA process Disaster/contingency plan(s) to protect business operations Adaptation to sponsor s SOPs Results of previous regulatory inspections 7

8 Considerations in Selecting a CRO Capacity and Flexibility Expansion with changing needs Resources to deal with uncertainties Handling additional assignments Capability and Credibility Diversity of experience Experienced people Adequate facilities Training and incentives for people Confidentiality 8

9 Considerations in Selecting a CRO Documentation change control processes Review of required accreditation Personnel qualification, job descriptions, organizational charts, training plans etc. Data transfer process References from previous customers Outcomes of previous regulatory inspections Security of physical locations where services are provided (server rooms, file rooms, etc.) The number of sponsors or studies currently supported by the available CRO staff 9

10 Key Factors for High Data Quality Detailed start-up meetings ( face-to-face) Overview of the whole program Ensure that processes for both companies are described in detail (SOPs and training) Define the roles and responsibilities for sponsor and CRO Discuss expectations of both teams in regard to deliverables, timelines and resource Communication and decision-making strategy Issue resolution process Budget planning and management Expectations and performance metrics 10

11 Key Factors for High Data Quality The Most Common Sources of Conflict In recent industry survey, both Sponsor and CRO agree that the top sources of conflict are related to mismatched expectations. Pharma: 88% agree Service Providers: 92% agree For Sponsor Expected innovation does not materialize Scope changes lead to additional costs Off-contract purchasing undermines expected savings Project delays due to supplier For CRO Expected volumes do not materialize Changes in requirements lead to increased & unrecoverable costs Customer does not provide committed resources Project delays due to customer Quality problems 11

12 Key Factors for High Data Quality Define Acceptable Metrics in Data Management (Time, Cost, Quality and Quantity) Data Management Process Study prepare phase Study conduct Study closeout KPI CRF design duration Database setup duration CRF received->data entry Data entered -> query generated Query generated-> query reviewed Query resolution time LPLV-> database lock Error Rate (data entry, CRF vs database) 12

13 Key Factors for High Data Quality At Study Setup Phase To clearly define the roles and responsibilities for DM CRO Data Management Task Description Sponsor CRO Data Management Plan CRF Design and Annotated CRF Database Setup Validation Program CRF tracking Data Entry Discrepancy Management Coding (MedDRA or WHO DD or both)... 13

14 Key Factors for High Data Quality At Study Conduct Phase To have a good communication channels (weekly basis or as needed) CRO Report any findings during study conduct Submit weekly progress report Summary data quality CRF pages received CRF pages entered/cleaned Missing and/or expected CRFs Queries sent/outstanding/resolved Interim Analysis Sponsor Decision maker on any issues reported Or approval lfor the actions As reviewer Focus on QA or QC Safety and efficacy data Timeline 14

15 Key Factors for High Data Quality At Study Closeout Phase To follow database lock procedures and to lock database on time CRO Database lock Prepare DB lock checklist All data entered Any open query SAE reconciliation Coding QC Lock database and dataset transferring Sponsor Timeline for Database lock Special query handling Data quality review SAE reconciliation resolving Database locking approval Check all docs completed and signed Paper CRF Datasets DMP 15

16 Best Outsourcing Relationship Understand, learn and respect each other Careful selection and detailed contract vital for a long term successful relationship Sponsors need to carefully assess the requirements of CRO CRO needs to understand expectations of sponsor Mutual benefit from the relationship Support from senior management Set measurable goals and objectives Performance measurement and feedback Periodic, formal and fact-based relationship Progress review process in place Communications and conflict resolution process Feedback and evaluation 16

17 Thank you! Q&A Contact info: 17