Metrics for Clinical Trial Contracts

Enhancing Clinical Investigation by Improved Management:

June 23rd & 24th 2008 Bethesda, MD

James A. Moran JD, CPAWashington University School of Medicine

Assistant Dean Clinical TrialsPhone: (314) 362-6864

Email: moranj@wustl.edu

Department begins budget negotiations with Sponsor

Budget is finalized

WAIT

NO

PI notifies CCS re: study & sends initial pppwk*

CCS starts file and enters study into database; requests additional documents

Once all necessary documents received, study assigned to Contract Specialist.Specialist reviews contract, and begins negotiations with Sponsor.

Contract language approved

Budget approved?

Contract signed

YES

Study submitted to PRMC, if applicable

Study approved by PRMC, if applicable

Study submitted to IRB

Study approved by IRB

Study begins enrollment

IRB

Budget

Contract

Dept.reviews protocol/budget to

determine if they want to do study

STOP

NO

YES

*If study falls under Master Agreement, no contract negotiation is needed: only need budget approval for contract to be signed.

Contract Process Overview

2

Sponsor

Dept

PI & Cord

CCS

BJC Purchasing

If IIS, develop Protocol

Send Contract

Send info* to CCS

Send email that CCS can't proceed &

requesting add'l info from PI

Wait

Enuf info* to proceed?

Review contract, trigger Stage 2

tasks

N

Complete Budget &

Pmt Schedule

Provide Budget Input

Sign WU conf & IP agrmts

Provide Budget Input

Send proposed changes to sponsor & set up

negotiation telecon with sponsor legal &

budgets

Sign

Sign

Sign

Negotiate Budget & Pmt

Schedule

Negotiate

* Minimum info is expediter form, contract,informed consent, risk/benefit survey & protocol

Start

Stage 1 Stage 2 Stage 3 Stage 4

Begin Processing

Y

Execute Indem Decision Tree

(I)

Execute Pub Decision Tree

(P)

Execute Ins Decision Tree

($)

Execute Negotiate portion of (P),

($), (I), (IP) Decision Trees as

required

Execute IP Decision Tree

(IP)

Develop position on other issues

University Policy

3

Contract Data Collected

4

Definitions of Data Fields Collected• Date Initial Contact: The date on which we are first

notified of a study.• Date Contract/Clinical Study Expediter Form (CSE) is

Rec’d: 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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6

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Contracts Received

8

Contracts Completed

9

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

• 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• 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• 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 everyone’s 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• 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 institution’s requirements change.

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Important Contract Rules of Thumb• We try and maintain an average of 25 to 45 open

contracts per negotiator– The WU contracts office consists of 6 FTE’s (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• 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 WashU’s 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.

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