2012 Avoca Quality Summit Report

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<ul><li> 1. THE AVOCA GROUP INAUGURAL QUALITY SUMMIT ESTABLISHING A BEST-PRACTICE APPROACH TO QUALITY MANAGEMENT AND CRO OVERSIGHTOperationalizing Best Practices in Proactive Quality Management</li></ul><p> 2. Never underestimate the power of a small group of committed people tochange the world. Indeed, it is the only thing that ever has.Margaret MeadThe Avoca Quality Summit, held May 1-2, 2012, in New Brunswick, NJ,was the official kick-off of The Avoca Groups Quality Consortium, acooperative effort that brings together quality, outsourcing, and operationalprofessionals from member pharma, biotech, and CRO organizationsto accelerate the development of a best-practices approach to qualitymanagement and CRO oversight. To date, the Avoca Groups QualityConsortium includes 27 members: 16 from pharma/biotech companies and11 contract research organizations (CROs) (see Table 1). The corporatesponsors of the Quality Consortium are Eli Lilly &amp; Co. and Pfizer Inc.PharmaNet/i3 was the corporate sponsor of the Quality Summit. 3. TABLE OF CONTENTSCONSORTIUM MEMBERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1MISSIONS AND GOALS OF THE QUALITY CONSORTIUM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1HISTORY OF THE CONSORTIUM: Opening Windows of Opportunities . . . . . . . . . . . . . . . . . . . . . . . . . 2 2012 Avoca Consortium on Quality: Quality Delivered by CROs (Sponsor Data) . . . . . . . . . . . . . 2THE AVOCA QUALITY SUMMIT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SUMMIT DAY 1: First Steps Toward Creation of a Quality Agreement Template andQuality Metrics Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 SUMMIT DAY 2: Exploring Issues Around Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4ROUNDTABLE 1: Documenting Expectations for Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Does quality drive price up? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Defining quality and articulating expectations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Empowering individuals to reach for quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Is having standards practically achievable? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The elephant in the room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 The burning platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Summing it up - Roundtable 1: Issues and suggested actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12ROUNDTABLE 2: What are the Considerations when Implementing ComprehensiveMetrics Programs? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Measuring quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Quality is hard to define . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Pooling data to achieve a standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Controlling the perverse side of metrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Deciding to share information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Summing it up - Roundtable 2: Issues and suggested actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16ROUNDTABLE 3: Ensuring High-Quality Oversight in Global Trials in Emerging Regions . . . . . . 17 Quality over cost . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Parallels to Moneyball . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Summing it up - Roundtable 3: Issues and suggested actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18ROUNDTABLE 4: What Does the Future Hold for Sponsor/CRO Strategic Partnerships? . . . . . . 19 Will developing more consistent and agreed-upon approaches to quality agreements and metricslead to more satisfaction and better performance? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 The implications for CROs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 CROs: Learn to come to the table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Which business models for sourcing are best for quality improvement? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Summing it up - Roundtable 4: Issues and suggested actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24NEXT STEPS: The Future of the Avoca Quality Consortium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 4. CONSORTIUM MEMBERS Pharma, Biotech, and Device CompaniesClinical Service Providers Alexion Pharmaceuticals Chiltern International Amgen Covance Astellas Pharma Harrison Clinical Research AstraZeneca INC Research Biogen Idec ICON Bristol-Myers Squibb PAREXEL International Cerexa PharmaNet/i3 Cubist Pharmaceuticals PRA International Eli Lilly &amp; Co. Quintiles GlaxoSmithKline RPS Grnenthal Theorem Clinical Research ImClone Systems Janssen Research &amp; Development Pfizer Purdue Pharma RocheMISSIONS AND GOALS OF THE QUALITY CONSORTIUMConsortium members have a common mission: (1) to optimize their individual companies approaches toquality management within a short time frame, through collaboration with other Consortium membersand The Avoca Group, and (2) to effect change overall in the industry by creating a new paradigm andstandard for managing the quality of outsourced trials and programs.The Quality Consortiums short-term goal is to create standards for Quality Management, with a focuson Quality Agreements and Quality Metrics. The groups long-term goal is to develop a new paradigm inthe approach to Quality Management and partnering with CROs to ensure high quality and mitigate riskwhile introducing efficiencies and potential cost savings. Members of the Consortium will work togetherto establish mutually agreed-upon Quality Management standards in order to strengthen partnerships andreliability throughout the industry.The Avoca Group Inaugural Quality Summit: Establishing a Best-Practice Approach to Quality Management and CRO Oversight.1 5. HISTORY OF THE CONSORTIUM: Opening Windows of OpportunitiesThe Avoca Groups 2011 Report on Quality and CRO Oversight identified a number of thought-provoking issues and gaps between sponsors and CROs in the area of quality. The data from 2011also identified areas of opportunity, particularly in the development of proactive approaches to qualitymanagement. Avoca formed the Quality Consortium to address challenging areas head-on and todevelop more consistent approaches to the proactive management of the quality of outsourced trials.According to Patricia Leuchten, Avocas President and CEO, We know that sponsor companies arestriving to become more efficient in the oversight of CROs and to reduce the duplication of effort whilefocusing on maintaining very high quality. 2012 Avoca Consortium on Quality: Quality Delivered by CROs (Sponsor Data) Over the last 3 years, the quality delivered by our CROs has been*:N = 167 7% Better than the quality delivered by our in-house teams. The same as the quality delivered by our 34% 59% in-house (sponsor) teams. Worse than the quality delivered by our in-house teams.*Data from the 2012 Avoca Consortium on QualityEliminating duplication of effort requires collaboration on a higher level, and Avoca sees its role as acatalyst for moving things forward. While there is no one-size-fits-all formula for oversight that can beapplied to all organizations, Ms. Leuchten believed the time was right for the formation of a consortiumto work together to bridge gaps and to develop mutually agreed upon standards for quality.Avoca is using its consultants, subject matter experts, and partners such as the Metrics ChampionConsortium (MCC) to move things forward quickly. The Consortium and Summit are opportunitiesto improve outcomes through collaboration in Quality Management and metrics, Ms. Leuchten says.It is a forum to share industry best practices and establish new standards, and it represents a significantopportunity - because we have the industrys leaders together.The Avoca Group Inaugural Quality Summit: Establishing a Best-Practice Approach to Quality Management and CRO Oversight.2 6. THE AVOCA QUALITY SUMMITConsortium members attending the Quality Summit engaged in interactive discussions and collaboratedon how best to implement robust quality programs in their organizations to improve the quality andoutcomes of outsourced clinical trials. The Summit was the first of what will be several opportunitiesto collaborate on the implementation of new standards. In short, it provided a forum to find proactive,rather than reactive, approaches to the fundamental challenges the industry is facing.SUMMIT DAY 1: First Steps Toward Creation of a Quality Agreement Template andQuality Metrics Document.On Day 1 of the Quality Summit, 50 sponsor pharma/biotech members of the Avoca QualityConsortium reviewed new data from Avocas 2012 Quality Consortium Assessment Sponsor Survey anddiscussed the creation of Quality Agreement template/standard that applies to many outsourcing models.A draft template that was created by Avoca based on a compilation of sponsor companies individualQuality Agreement templates was reviewed and discussed. (CRO members of the Consortium are now inthe process of reviewing and providing comments on the second draft of this template.)Consortium members working on the Quality Agreement template/standard decided that a morestreamlined template was needed to make it easier to move toward an industry standard. It wasdetermined that functional details should be omitted from the standard template since this languagetypically appears in other types of documentation such as monitoring and data management plans. Thelanguage and text specific to functional areas will be preserved in a separate repository of information sothat members have access to the specific language if they need it. Thus, there will be references to thesedetails in the Quality Agreement.Consortium members also worked on the creation of a Quality Metrics document, creating a list of 12-15essential metrics focused on measuring quality.In advance of the Quality Summit, sponsor Consortium members were asked to submit their qualitymetrics to Avoca. These were reviewed and consolidated prior to the Summit. We were provided withcycle time and performance metrics and some relationship metrics, noted Lisa McKay, Avocas SeniorDirector of Relationship Management Programs. We also saw a great variation in what types of metricspeople are using, so it was obvious that there is a real need to develop standards and really assess andaddress how the industry is defining quality metrics.Cycle time metrics and performance metrics not directly related to monitoring of quality were taken outof the final mix, leaving 116 metrics that were provided to sponsor members of the Quality Consortium asa starting point for their work.The Avoca Group Inaugural Quality Summit: Establishing a Best-Practice Approach to Quality Management and CRO Oversight.3 7. The 116 metrics fell into 3 categories: Quality of operations in outsourced trials (or in-sourced trials); Oversight of investigative sites; Quality of response to findings.Using these 116 metrics, each individual was asked to select the top 12-15 that would become essentialto measuring quality in clinical trials. There is still work to be done, Ms. McKay said, but we did see agreat deal of consensus on some aspects. Avocas next step is to get input from CRO members and thento work closely with the MCC to integrate the quality metrics into MCCs system of organizing metricsby work streams.The Quality Metrics document is still a work in progress, but the top 3 metrics that emerged at the end ofDay 1 were:1. Number/percentage of repeat audit findings or issues after corrective and preventive actions (CAPAs)have been implemented;2. Percentage of personnel passing Good Clinical Practice (GCP) compliance and CRO/sponsorStandard Operating Procedure (SOP) testing prior to being assigned to the project;3. Percentage of significant quality issues as defined in the Quality Management Plan (QMP), escalatedto the sponsor within a defined timeline.SUMMIT DAY 2: Exploring Issues Around Quality.Day 2 of the Quality Summit, open to Consortium members and non-members, featured fourroundtables focused on 1) documenting expectations for quality, 2) measuring quality, 3) exploring howto ensure high-quality and proper oversight in emerging regions, and 4) strategic alliances and howpartnering has an impact on quality.The message permeating the days roundtables and presentations was the need for collaboration andcooperation at the highest possible levels of the industry. Weve got a collective problem that impactsour jobs, our abilities to get medicines to patients, said Jeffrey Kasher, PhD, Vice President and COO ofGlobal Medical R&amp;D at Lilly. We as individuals and individual organizations cant solve this problem-its bigger than any one of us. But Im convinced that if we work collectively, we can solve the problemand move the needle forward. Dr. Kasher echoed what Patricia Leuchten noted earlier about Avocasgoal in launching the Consortium and Summit: It starts with a group of people driving change; thenthe rest of the folks come along. We have to drive c...</p>

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