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