Leveraging CRO Partnerships to Increase Speed of Study Execution Time Kevin J. Anderson, MBA Associate Director, Clinical Operations
Leveraging CRO Partnerships to Increase Speed of Study Execution Time
Kevin J. Anderson, MBA
Associate Director, Clinical Operations
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Context
• Team was in a situation where:
○ A significant number of new sites were needed
○ Current selected sites were taking too long to open
▪ Start up processes were inefficient and slower than anticipated
○ Current open sites were not enrolling
▪ Having a hard time finding patients
▪ Lacking the tools to reach out to them
○ We needed to come up with quick solutions
▪ Patients in desperate need (few other options in rare disease)
▪ Trial progress closely monitored by senior management
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Systematic Process Examination
• Sponsor team went to vendor for 2 days of brainstorming
• Broke down key processes involved within:
○ Regulatory submissions/approvals
○ IRB/EC submissions/approvals
○ Contract execution
• Assessed within each arena:
○ What was working optimally
○ What could be improved and how
• Made recommendations to senior management on changes to
implement and were approved
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Recommendations
• Increase up front costs and build out the team
• Integrate Sponsor/CRO teams in Regulatory/EC submission processes
and leverage their expertise
• Approve countries at-risk
• Synchronize Sponsor/CRO contract execution activities
• Employ evidence based site selection
• Implement a branding and social media strategy for patient recruitment
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Increase Up Front Costs
• Pay now or pay later
• Increased costs today, while significant, are small compared to loss of
future revenue due to delayed timelines
• Sponsor staff levels lean
• Key roles were lacking on CRO team - determined that adding them was
essential to improving execution speed
○ Global Start Up Lead
○ Regulatory Advisor
○ Medical Monitor
• Novel role determined to likely add value:
○ Clinical Trial Educator
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Utilize CRO expertise and expand the team
• Global Start Up Lead
○ Central point of contact for Sponsor team
○ Ensure efficiencies are realized across regions
○ Ensure process consistency across the program
• Regulatory Advisor
○ Strategic assistance to Sponsor Regulatory team
○ Provide oversight across country submissions
○ Ensure efficiency/process consistency across regions
• Medical Monitor
○ Additional manpower for Sponsor Medical Monitor
○ Speaks local languages
○ Backup study medical contact for Medical Monitor
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Utilize CRO expertise and expanding team (cont.)
• Clinical Trial Educator1 role:
○ Educating the principal investigator and site staff in successful enrollment
techniques
○ Networking with health care facilities/providers that may refer potential study
patients
○ Reducing screening loss of otherwise excluded patients from trials through
identification prior to initiation of other therapies
○ Sharing best practices in focus groups of study coordinators or investigators
○ Using their insight to offer creative solutions to recruitment barriers and providing
suggestions to the trial team for development of recruitment tools
1 Quintiles Clinical Trial Educator Proposal, 22 Aug 2014
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Integrate teams in Regulatory/Ethics Committee (EC) Submissions
• Regulatory Kick Off Meeting to:
○ Systematically review country specific documentation/activity requirements and
process flow for EC/Regulatory submission
○ Map out risks and mitigation by country
• Countries to be tiered:
○ In order of 1st step activities (e.g. Reg. submission, EC submission, contract
execution)
○ In order of average start up time
• Daily communication/weekly calls between Sponsor/CRO Regulatory and
Start Up groups
• Joint SharePoint folders for EC/Ministry of Health (MOH) submission
coordination
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Engage in At-Risk Activities
• Sites will not be selected prior to review of final Site Selection Visit
reports, however, countries to be selected in advance
• Once sites with strong recruitment potential (determined in global
feasibility exercise) express interest, discussion held with Medical
Monitor and official “Go” given to CRO on country
• Upon receipt of sponsor approval, Global Start Up Lead and Regulatory
Advisor to work together with local country leads on:
○ Country specific ICF/patient material translations
○ Contract templates/budget preparation for ECs
○ Delegation Letter execution
○ Ensuring compliance with local data protection requirements
○ Obtaining insurance certificates
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Synchronize Sponsor/CRO contract execution activities
• List of current potential sites/countries to be reviewed by Sponsor/CRO
Legal/Contracts groups on an ongoing basis:
○ Known “problem” countries/sites are identified early
○ Library of contracts parameters are being reviewed for those countries
○ Applying forward contracts language previously utilized by Sponsor or CRO
• Once a country is selected: o CRO pulls existing contract template or develops a new one
o Modifies based on specific study requirements to be ready when site selected
• Weekly calls between Sponsor/CRO Legal/Contracts groups to review and
coordinate ongoing contract activities
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Employ Evidence Based Site Selection
• Challenging estimates provided by sites in global feasibility
• Utilizing De-Identified Pre-Screen logs:
○ Checklist of key inclusion/exclusion criteria to be met
• Logs to be sent to sites in advance of Site Selection Visit (SSV)
• Potential patient profiles to be reviewed at SSV
• Patient profiles are to be a key driver for site selection decision
• Currently in discussion with CRO Medical Informatics group, exploring
the utilization of their database assets to:
○ Identify new sites based on ICD-9/other treatment data
○ Determine accuracy of information provided through feasibility surveys
○ Build analytics around percent of patients eligible to help drive future decisions
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Implement a Branding and Social Media Strategy
• Traditional printed outreach:
○ Dear doctor/Dear patient letters
○ Patient/Health Care Provider (HCP) posters/brochures
• Digital outreach:
○ Search engine optimization
▪ Paid search terms
▪ Google Plus Pages
▪ LinkedIn show case page
▪ Study Landing Page
○ Targeted LinkedIn posts and advertisements to HCPs
○ Study outreach through Patient Advocacy websites
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Summary
• Recommend:
○ Increasing up front costs and building out the team
○ Integrating Sponsor and CRO teams in Regulatory/EC submission processes and
leveraging their expertise
○ Approving countries at-risk
○ Synchronizing Sponsor/CRO contract execution activities
○ Employing evidence based site selection
○ Implementing a branding and social media strategy for patient recruitment
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Key Take-Aways
• Pay now in up front costs so you can avoid paying later in longer
timelines/higher costs
• Employ a robust CRO team from the beginning
• Capitalize on creative solutions your CRO can offer:
○ Roles such as the Clinical Trial Educator
○ Evidence based site selection
○ Expertise in patient recruitment
• Leverage the “intelligence” of your CRO regulatory/legal/contract groups
• Synchronize all key activities