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Getting a Clinical Research Protocol Started The CTSA Response

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Vice Dean for Clinical Investigation. Director, Institute for Clinical and Translational Research ... Enhancing Clinical Investigation by. Improved Management ... – PowerPoint PPT presentation

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Title: Getting a Clinical Research Protocol Started The CTSA Response


1
Getting a Clinical Research Protocol Started The
CTSA Response
  • Daniel E Ford, MD, MPH
  • Vice Dean for Clinical Investigation
  • Director, Institute for Clinical and
    Translational Research
  • Johns Hopkins School of Medicine

2
Current State
  • Time to initiate studies longer for US than most
    countries
  • Steps required to start study are increasing (ex,
    billing for services provided in clinical trial)
  • Recent NCI analysis found that for cooperative
    group phase 3 trials time from original idea to
    activation of study was 808 days (481 distinct
    processes)

3
June 22-23, 2008
  • Enhancing Clinical Investigation by
  • Improved Management
  • A Workshop Convened by the
  • Clinical and Translational Science Award (CTSA)
    Consortium/
  • Regulatory Knowledge Workgroup/
  • Clinical Research Management Taskforce

4
Organizing Committee
  • Teshia Johnson, MBA Yale
  • Michael Joyner, MD Mayo
  • Robert Califf, MD Duke
  • Daniel Ford, MD, MPH Johns Hopkins
  • Daniel Rosenblum, MD NIH NCRR

5
Premeeting Survey
  • Three surveys similar
  • to each of 24 CTSA institutions
  • CTSA PI (representing researcher perspective)
  • IRB Director
  • Research Administration (contracts) Director

6
PI Survey Results
  • 4 Institutions post performance measures for IRB
    and contracting
  • IRB barriers
  • Incomplete applications from research teams
  • Infrequent meetings of IRB or subcommittees
  • IRB committees too picky about wording

7
PI Survey Results
  • Major barriers for contracting
  • Even if Master agreements in place, they are not
    followed by companies
  • Legal review too slow
  • Difficult negotiations related to
    indemnification, publication rights and data
    transfer

8
PI Survey Results
  • 84 contracting longer than IRB
  • 5 IRB longer than contracting
  • 11 equal time for both
  • Where delays occur
  • 36 sponsors
  • 48 academic centers
  • 21 PIs and research teams

9
Research Administration Survey
  • Huge variation in organizational structure
  • 36 of staff have left in past three years
  • 78 of contracts tracked electronically
  • 34 of those faculty can view status of contracts
  • 50 report not meeting with one sponsor in 2007
    to discuss contracting

10
IRB Survey
  • Average of 2025 protocols approved in 2007 (682
    convened)
  • Average of 18 staff
  • 50 turnover since 2005
  • 50 of protocols tracked electronically
  • 50 of institutions do not pay their IRB members
  • 55 met with no sponsors/NIH in last year

11
Agenda for Workshop
  • Stakeholder perspective on problem
  • Walter Koroshetz, MD NINDS
  • Nancy Trapp, Eli Lilly Sponsor
  • Tony Perez, JD IRB
  • Gary Chadwick, PhD Alternative IRB
  • James Moran, JD Contracts
  • Sara Rockwell, PhD Faculty

12
Agenda for Workshop
  • Discussion groups addressing specific questions
  • Poster session where everyone could share best
    practices and recent quality improvement programs

13
Why do we need research study initiation
performance measures?
  • Perception of sponsors and research faculty we
    are inefficient
  • No other accreditation organization has taken on
    this role
  • Association of Human Resource Protection Programs
    (AHRPP)
  • Office of Human Research Protections (OHRP/HHS)
  • Federal Drug Administration (FDA)
  • Opportunity for the doers to be proactive and
    lead the way

14
Why do we need research study initiation
performance measures?
  • Measurement is the first step to understanding
    the process
  • Same metrics across multiple academic sites
    allows comparisons and identification of best
    processes (ask for more resources if not
    performing as expected)
  • Measurement of performance metrics tends to
    reduce variability

15
Why do we need research study initiation
performance measures?
  • Posting metrics for sponsors and public
    demonstrates responsibility and accountability
  • Once we demonstrate accountability, can ask for
    same from sponsors and research teams

16
Challenges to Measuring Performance
  • Selecting the right performance measures
  • Are study protocols included in the performance
    measure representative or informative?
  • Are the performance measures easy to measure?
  • Can the performance measures be measured with
    reliability?
  • Does the performance measure vary too much by
    type of study to be informative? (pediatric vs.
    adult, first site versus 50th site)
  • Do the performance measures provide hints about
    the process or what the path to improvement might
    be?

17
Challenges to Measuring Performance
  • Is speed the only measure of performance? What
    about quality of IRB review? What about quality
    of a contract that is clear and covers multiple
    potential problems?
  • Are there ways to game the performance measures?

18
First Performance Metric
  • Duration in days from receipt of first ready
    study protocol/site agreement received to time
    both the clinical investigational site and
    sponsor have executed the agreement

19
Performance Metric Definitions
  • What studies are included?
  • Multicenter clinical trials
  • Easier to assign date when site was able to start
    study initiation/approval process
  • Include all sponsors (NIH and commercial)
  • Dates
  • 2007 chosen as most study protocols will have had
    opportunity to be activated

20
Performance Metric Definitions
  • When is start date?
  • Date agreement sent from sponsor
  • Date agreement is received
  • Research teams may not have recorded this date

21
Performance Metric Definitions
  • Time to executed site agreement
  • Total days or business days?
  • Is it date when one party signed agreement or
    when all parties signed agreement?
  • Possible to game this time by signing
    agreements quickly and then need multiple
    amendments to really have study ready to enroll
    participants

22
Performance Metric Definitions
  • Days to execution of agreements
  • How to count protocols that never were completed?
  • What about outliers?
  • Report median or 90th percentile?
  • Report 25, 50 and 75 percentile?
  • Report percent of protocols that met some
    performance standard

23
First Performance Metric
  • Duration in days from receipt of first ready
    study protocol/site agreement received to time
    both the clinical investigational site and
    sponsor have executed the agreement

24
(No Transcript)
25
Days to Contract Execution by Percentiles (Start
date when contract presented to Research Office)
26
IRB Performance Metric
  • Duration in days from PI receipt of protocol to
    site IRB approval
  • Measure protocol receipt to initial (department
    or IRB) submission
  • Measure protocol receipt to IRB submission
    complete
  • Measure protocol receipt to first IRB review

27
IRB Performance Metric
28
IRB Outcome Measures
29
Insights from Workshop
  • Valuable forum to bring together IRB and research
    administration professionals
  • Need to consider the entire study initiation
    process
  • Need to bring general counsels into the quality
    improvement process
  • Agree that establishing metrics will aid in
    quality improvement
  • Not certain if goal is to standardize study
    management across sites or maximize efficiency
    within each site with own solutions

30
Process For Implementing Study Initiation Metrics
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