Metrics for Clinical Trial Contracts

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Metrics for Clinical Trial Contracts
Enhancing Clinical Investigation by Improved
Management June 23rd 24th 2008 Bethesda,
MD James A. Moran JD, CPA Washington University
School of Medicine Assistant Dean Clinical
Trials Phone [phone] Email
moranj_at_wustl.edu
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Contract Process Overview
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Contract Data Collected
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Definitions of Data Fields Collected
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• Date Initial Contact The date on which we are
  first notified of a study.
• Date Contract/Clinical Study Expediter Form (CSE)
  is Recd The date on which we obtain all
  required documentation to begin negotiation
  (draft contract, protocol synopsis, CSE Form
  consent). This is our
  start date.
• Date On Hold The date a contract is placed on
  hold due to extenuating circumstances (e.g.,
  protocol is being rewritten).
• Date Completed The date WU signs the agreement
  or the clinical trial is dropped.
  This is our end
  date.

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Contracts Received
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Contracts Completed
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Contract Turnaround by Contract Type
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Improving the Contract Process A WashU Case
Study
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Analysis of 6 Contracts Showed These Causes
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• Average elapsed days for 6 contracts 158
• Average days lost to
• Facilitating Hospital issue resolution 46
• Sponsor review 37
• Risk assessment 24
• Wait for PI/dept action 19
• Rigid Institutional negotiating position 13
• Incomplete data 11
• Budget development 10
• Dept review 3

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Issues Contributing to Poor Contract Negotiating
Time
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• WU begins with most conservative negotiating
  position on each issue and with each contract
• Each trial involving the hospital is a separate
  negotiation
• Requires three-party agreements
• Contracts data package is incomplete
• Contracts office must wait for complete data, but
  the clock is ticking
• Increases negotiation time while negotiator is
  gathering pertinent information
• PIs and Depts assume contracts office is taking
  care of everything
• PIs and Depts do not realize that they also have
  required actions
• Sponsors have limited attention span
• If no WU action within a month or so, they move
  on
• If WU position seems unreasonable they put us at
  the bottom of the pile

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Requirements for an Improved Contract Process
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• Determine acceptable contract requirements early
• Develop best practice guidelines that indicates
  preferred, acceptable and unacceptable contract
  positions for Budgets, Indemnification
  Insurance, Publication restrictions, and
  Intellectual Property
• Frequent access to appropriate decisions makers
  (e.g., meetings twice weekly with General Counsel
  and biweekly meetings with Vice Chancellor for
  Research)
• Require a complete contract package before
  negotiation time begins
• Requiring receipt of internal forms, protocol and
  consent at the beginning will reduce time for
  negotiations so that all information is available
  first
• Negotiate master agreement with affiliated
  hospitals
• Contracts office provides a reasonable initial
  contract response to sponsor within a short
  period of time (2-4 weeks)
• Addresses sponsor attention span issues
• Keeps the contract fresh in everyones mind and
  moving forward
• May require analysis of work load and staffing
  issues
• Negotiate master agreements with repeat sponsors
  to eliminate re-negotiation of terms

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Important Contract Rules of Thumb
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• Our goal is to maintain an average of 70 of
  Clinical Trial Contracts completed within 45
  days.
• This typically beats the IRB turn-around time so
  we are not the ones holding things up
• Our experience shows that this also results in
  zero complaints to the Dean so it also meets the
  squeaky-wheel test
• Could this be done quicker? . . . Probably . . .
  but the trend is toward more and more restrictive
  agreements that protect the institution so we try
  and maintain this performance as institutions
  requirements change.

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Important Contract Rules of Thumb
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• We try and maintain an average of 25 to 45 open
  contracts per negotiator
• The WU contracts office consists of 6 FTEs (a
  Director, 2 Senior Negotiators, 2 Contract
  Specialists, and a Contract Secretary)
• We have found that if we exceed 45 contracts per
  negotiator then our response times to pharma
  suffer leading to larger and larger backlogs
• We have also found that the communications
  required to manage expectations of the faculty
  suffer as well which leads to faculty complaints

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Important Contract Rules of Thumb
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• We have developed a Black Book of negotiating
  terms and conditions
• Contains preferred, acceptable, and unacceptable
  conditions.
• This manual is a living document that changes as
  WashUs negotiating position changes.
• Unacceptable conditions are discussed at
  meetings held twice a week with the General
  Counsel during negotiation.
• If the negotiation results in an unacceptable
  condition an exception may be granted by the Vice
  Chancellor for Research on a case-by-case basis.
• If the negotiation position ends in acceptable
  terms the Assistant Dean for Clinical Trials can
  immediately sign the agreement.