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