Metrics for Clinical Trial Contracts

1. 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: (314) 362-6864 Email: moranj@wustl.edu

2. Dept. reviews protocol/budget to determine if they want to do study Department begins budget negotiations with Sponsor Budget is finalized Study begins enrollment NO STOP Once all necessary documents received, study assigned to Contract Specialist. Specialist reviews contract, and begins negotiations with Sponsor. PI notifies CCS re: study & sends initial pppwk* CCS starts file and enters study into database; requests additional documents IRB Contract language approved YES Budget approved? Contract signed Study submitted to PRMC, if applicable Study approved by PRMC, if applicable Study submitted to IRB Study approved by IRB NO WAIT Budget YES Contract *If study falls under Master Agreement, no contract negotiation is needed: only need budget approval for contract to be signed. 2 Contract Process Overview

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4. 4 Contract Data Collected

5. 5 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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8. 8 Contracts Received

9. 9 Contracts Completed

10. 10 Contract Turnaround by Contract Type

11. 11 Improving the Contract Process:A WashU Case Study

12. 12 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

13. 13 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

14. 14 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

15. 15 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.

16. 16 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

17. 17 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.