Next Steps: Plan for Larger Future Study and Where is the Next Study Taking Us

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Next Steps Plan for Larger Future Study(and
Where is the Next Study Taking Us)

• Daniel E Ford, MD, MPH
• Director, Institute for Clinical and
  Translational Research
• Vice Dean for Clinical Investigation
• Johns Hopkins School of Medicine

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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
• Opportunity for the doers to be proactive and
  lead the way
• CTSA Network has unique opportunity to lead the
  process for academic centers

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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

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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

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What have we learned so far?

• Substantial proportion of IRB and contracting
  professionals at the CTSA institutions have
  committed to the process of measuring their work
  processes using the same standardized approach
• Champions of Change at each institution can help
  catalyze the process
• Preliminary agreement on what data points to
  collect
• We have a process for entering the data
• Data collection burden is not that great

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Challenges remaining

• Need to create process for measuring the entire
  prestudy process (combining IRB and contracting
  components)
• Need to assess if there are certain types of
  studies that have substantially different
  performance times (stratification of results)
• Multicenter vs single site
• Studies with vulnerable populations (ex,
  children)
• Studies with investigator held INDs
• Studies with new investigators

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Challenges Remaining

• Need to develop a meaningful way of describing
  current institutional resources devoted to
  prestudy processes
• Need to consider additional measures of
  performance beyond time to completion
• Quality of process
• Costs of process

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Decision Regarding NewIRB Processes
Review Quality
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Where are we heading?

• Goal of the website is not to differentiate
  between the high performing and low performing
  sites but to document improvement in performance
  of all CTSA institutions

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Where are we heading?

• Website that presents performance data
• Who is the sponsor of the website?
• Are institutions identified?
• Are the data presented as average days to
  completion, percent of time met a standard, or
  with more vague criteria (1 to 5 stars)?
• What other data about the institution (resources,
  processes, volume, types of research) will be
  presented?
• What about data on quality being included on the
  website (AAHRPP accreditation)?

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