Industry Sponsored Trials at Academic Medical Centers: Goals and Requirements

1
Industry Sponsored Trials at Academic Medical
Centers Goals and Requirements

• 2nd Annual Clinical Research Management Workshop
• Briggs W. Morrison, MD
• June 22, 2009

2
Agenda

• Criteria for selecting investigative sites
• How are the CTSA institutions doing?
• Process improvement opportunities

3
Selecting investigative sites

• Quality
• Patient experience
• Patients relevant to the protocol hypotheses
• Ability to meticulously follow protocol
• Data complete, accurate. and interpretable
• Speed
• Initiating the trial
• Enrolling patients
• Cost

Why would we chose your site over other CTSA
sites or non-academic sites?
4
CTSA Performance Analysis Methods

• Pfizer sponsored trials 2006 present
• Compare CTSA institutions with other Academic
  Medical Centers and with non-academic research
  sites
• US sites only
• Data displayed as median with box (25-75).

5
Quality Metrics

• Patient experience
• Patients relevant to the protocol hypothesis
• Number of patients enrolled
• Predictability of enrollment projections
• Ability to meticulously follow protocol
• Protocol violators
• Data complete, accurate, and interpretable
• First pass data quality

6
Can the site enroll even 1 patient?
0.7
0.6
0.5
0.4
Proportion of
Performing sites
0.3
0.2
0.1
0
Non
AMC
CTSA
AMC
Other
AMC
30 of activated sites do not enroll a single
patient
7
Can the site enroll at least 3 patients?
50 of activated sites do not enroll more than
3 patients
8
Protocol Deviations
9
Protocol Deviations (normalized within protocol)
10
Speed Metrics

• Initiating the trial
• Final approved protocol (FAP) received at your
  site until site screens first patient (FSFV)
• Final approved protocol received at your site
  until final contract signed
• Enrolling patients
• First patient enrolled to last patient enrolled
• Predictability of enrollment projections

11
Final Protocol to First Screened Patient
12
Final Protocol to Contract Signed
13
Final Protocol to Contract Signed (normalized)
14
Enrollment first screened patient to last
(normalized)
15
Cost Metrics

• Per patient clinical grants costs paid by Sponsor
• Actual costs of doing the work at your
  institution.
• Opportunity costs

16
Per Patient Costs
17
Per Patient Costs (normalized within protocol)
18
How are CTSA institutions doing?

• Within the limitations of this analysis, CTSA
  site performance is generally about the same as
  that of non-academic centers or other academic
  centers
• Overall a bit slower getting started
• Contracting takes longer
• There is significant variation between sites even
  within a given study.
• There is significant opportunity to increase
  speed and decrease opportunity costs.

19
Process Improvement Approaches

• Lean
• Positive Deviance

20
Think Lean

• Map all processes in detail
• Eliminate non-value added steps
• Data useful to determine if value added or not
• Eliminate muda, especially waiting.
• Mindset of relentless and passionate pursuit of
  perfect process.

21
Positive Deviance

• In every community, organization, or social
  group, there are individuals (positive
  deviants) whose exceptional behaviors or
  practices enable them to get better results than
  their neighbors who have the exact same
  resources.
• The solution already exists within this community
  it just needs to be discovered by its members.

22
In closing

• Set aggressive goals and beat them!
• All patients who participate in clinical trials
  at your institution will advise their friends and
  family to participate
• Every trial activated at your institution will
  enroll at least 5 patients.
• The time from when you receive the final protocol
  until you enroll your first patient will never
  exceed 100 calendar days
• The time from when you receive the final protocol
  until you have an agreed contract and budget will
  never exceed 30 days.
• No trial conducted at your institution will have
  a protocol violation.
• The first pass data quality will approach 100
  for all trials conducted at your institution.