Project Management Standards Applied to Complex Clinical Trials. Disclaimer

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1 Project Management Standards Applied to Complex Clinical Trials Alexander Gissler, PMP ProjectPharm Ltd., Owner & Director 1 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2

2 Topics Typical Issues in Clinical Trials Project Management Standards Some Project Management Standards Key Knowledge Areas PM Standards and Clinical Trials Summary 3 Typical Issues with Clinical Trials Duration and Cost exceeded Too many uncertainties (assumptions) No effective cost control No effective schedule control Reactive Risk Management Risks are addressed too late Risk prevention is not a team effort No budget for contingencies 4

3 Typical Issues with Clinical Trials Quality Issues Quality issues detected late, e.g. systematic protocol violations prior to DB lock, or data issues detected once statistical analysis was completed Communication and Team Issues Rare and ineffective meetings No ongoing training 5 Typical Issues with Clinical Trials Frequent Scope Changes Stakeholders requests Regulatory requirements Marketing requirements Misunderstandings between sponsor and service providers regarding activities contained in agreed upon working packages / tasks 6

4 Project Management Standards PMBOK Project Management Body of Knowledge ICB International Competence Baseline PRINCE2 Projects In Controlled Environments Several national and industry specific standards 7 Project Management Standards Key PM Knowledge Areas: Scope Time Budget Human Resources Quality Communication and Stakeholders Risk Procurement Project Integration Integration of all areas Change control 8

5 PM Standards and Clinical Trials The well known PM standards (PMBOK, ICB, PRINCE2, etc.) are not industry specific Clinical trials are fully featured projects, having all characteristics of a typical project. 9 PM Standards and Clinical Trials Are the typical issues of clinical trials addressed by the key PM knowledge areas? Duration and Cost exceeded Reactive Risk Management Quality Issues Communication and Team Issues Frequent Scope Changes 10

6 Key Principles from PM Standard All Projects Are Unique There s no standard project plan which will perfectly fit. But it is useful to use plans of similar projects as templates. Project management team is responsible for defining project specific procedures, processes, planning detail and strategies, in the context of the performing organization. 11 Key Principles from PM Standard Monitoring & Controlling Processes Planning Processes Initiating Processes Closing Processes Executing Processes The Deming Wheel (Plan-Do-Check-Act Cycle) 12

7 Key Principles of PM Standards Planning is key for a successful execution of the project as well as for successful change control Planning how to plan is key for a good project plan! 21 out of 44 PMBOK processes are about planning 13 Summary Clinical Trials are projects and should be managed as such The most known project management standards are not industry specific. They can be applied to clinical projects and will address all of the recurring issues Good project planning is the key for success! 14

8 Any Questions? 15 Thank You Very Much! 16