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State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers. Ken Getz Tufts CSDD and CISCRP June 22, 2010. Study Conduct Risk and Inefficiency. 90% of all clinical trials delayed Since 1999: Inquiry Rates dropped from ~3% to <1%

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State of clinical research management the ongoing quest to recruit and retain study volunteers

State of Clinical Research Management The Ongoing Quest to Recruit and Retain Study Volunteers

Ken Getz

Tufts CSDD and CISCRP

June 22, 2010


Study conduct risk and inefficiency
Study Conduct Risk and Inefficiency

90% of all clinical trials delayed

Since 1999:

Inquiry Rates dropped from ~3% to <1%

Randomization rates from 75% of screened to 59% of screened

Completion rates from 69% to 48%

20% of the sites are responsible for 50+% of the patients; 20% of sites fail to enroll a single patient; 30% under-enroll

Approximately 7% of ALL sites actually deliver what they proposed in the feasibility assessment

High levels of turnover and poor sponsor/CRO systems compatibility

20% of Sites = 55% of Patients

Source: CIS, Tufts CSDD


Growing levels of non compliance
Growing Levels of Non-Compliance

# of Complaints: 15 106 111 139 266 245

Complaints filed as a percent of Active INDs

Note: includes all research INDs overseen by CDER, adjusted for submissions held due to agency concerns

Sources: Tufts CSDD


Public confidence and trust
Public Confidence and Trust

Sources: Research!America (JAMA, 2005); Ohmann (2004); HarrisInteractive (2002, 2004, 2007)


By extension study volunteers
By Extension… Study Volunteers

‘Who makes a better

contribution to mankind?’

  • Desperate (~29% believe only seriously-ill participate)

  • Risk Takers (80% believe participants are ‘gambling’ with their health)

  • Ambivalently respected (34% ‘Don’t Admire’ study volunteers)

Source: CISCRP, 2006; N=900


Primary strategies
Primary Strategies

  • Assurances

  • Sources of Volunteers

  • Technology solutions

  • Distribution Channels


Primary strategies1
Primary Strategies

  • Assurances

    • Professional certification and training

    • FDAA and publishing requirements

    • IRB accreditation

  • Sources of Volunteers

    • Extended global reach

    • ‘Hedging’ recruitment risk



  • State of clinical research management the ongoing quest to recruit and retain study volunteers

    Global Backlash

    Lancet 371; 2008


    Hedging recruitment risk
    ‘Hedging’ Recruitment Risk

    Mean Number of Patients per NDA

    Number of PIs Per Active IND

    * Includes all research INDs, adjusted for submissions held due to agency concerns

    * Does not include volunteers that participated in clinical studies not included with the NDA submission.

    Sources: Tufts CSDD


    Primary strategies continued
    Primary Strategies (continued)

    • Technology solutions

      • Clinical Trial Management Systems

      • Communication portals

      • Historical and predictive recruitment metrics

      • Integrated collaboration support systems

      • Online training and virtual MCMs

  • Distribution Channels

    • Traditional channels

    • Rapidly expanding arsenal of approaches to reach study volunteers


  • Changing recruitment approaches
    Changing Recruitment Approaches

    Incidence of Volunteers from External Sources

    Source: CenterWatch Surveys of Investigative sites



    Blogs social networking and twitter
    Blogs, Social Networking and Twitter

    • Rapid proliferation of Web 2.0 solutions to add to the recruitment arsenal

      • Opportunity to expand reach into targeted and broad communities and solicit rapid response

  • Crowded space

  • Broad ethical, regulatory and business concerns raised

    • Feb 3 – Market leader ‘Healogic’ exits citing a ‘difficult market’ that won’t be ready to truly embrace this solution for another 10 years



  • Ciscrp s public outreach initiatives
    CISCRP’s Public Outreach Initiatives

    Public

    &

    Patients

    CRE Stakeholders

    National Outreach

    and Education

    Local Outreach

    and Education

    • PSAs – Medical Heroes

    • CISCRP Membership

    • Edutainment

    • Media Outreach

    • Original Research

    • House Resolution 248

    • ‘Appreciation’ legislation

    • Post-Trial Results

    • Search Clinical Trials

    • AWARE for ALL

    • Educational Materials

    • (pre- and post-trial)

    • Medical Heroes packets

    • Speakers Bureau

    • Media Outreach

    • Science Museums

    • HS Science Initiatives


    Pre educating study volunteers
    Pre- Educating Study Volunteers

    • Print and video educational materials

    • Sites that pre-educated study volunteers

      • Had fewer and more effective screenings

      • Had patient randomization rates four times faster than sites that did not

      • Randomized the majority (68%) of the patients for the study


    Impact of medical heroes
    Impact of ‘Medical Heroes’

    Note: Pilot test involved two pain studies; 30 sites across 18 markets throughout the US

    Source: Eli Lilly & Company, 2007


    Communicating post trial results
    Communicating Post-Trial Results

    • Pilot program sponsored by Pfizer

    • Multiple formats

    • Study staff integral to entire process

    • Extremely positive reception from volunteers and sites

    • Planning national roll-out with several sponsors


    Rising protocol design complexity
    Rising Protocol Design Complexity

    Annual Growth Rate

    Compensation per Procedure

    Sources: Tufts CSDD analysis of 10,038 protocols, 2000-2006


    Cycle time metrics
    Cycle Time Metrics

    69% - 75% Increase

    Median Days Elapsed

    12% – 20% Increase

    Source: Tufts CSDD



    State of clinical research management the ongoing quest to recruit and retain study volunteers

    Thank You

    Ken Getz

    Founder and Chairman, CISCRP

    kengetz@ciscrp.org

    www.ciscrp.org

    Senior Research Fellow, Tufts CSDD

    Kenneth.getz@tufts.edu

    617-636-3487