Clinical Protocol Development Track 

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Clinical Training Forum Track 

Clinical Project Management Forum Track 

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Barnett International & Cambridge Healthtech Institute's Second Annual
Clinical Project Management Forum 2012
The Premier Event for Clinical Project Managers
October 11-12, 2012


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Friday, October 12

8:30 am Chairperson’s Welcome

The Effect of Risk-Based Monitoring on CPM

8:45 Strategies for Implementing Risk-Based Monitoring

Musa Mutaba, CCRA, Senior Clinical Research Associate, Infinity Pharmaceuticals, Inc.

The FDA recently released the “Risk-Based Approach to Monitoring Draft Guidance” to encourage Sponsors to use “alternative monitoring approaches,” and reveal the FDA’s thinking on “developing risk-based monitoring strategies and plans.” One of the alternatives to a traditional monitoring plan is targeted Source Data Verification (SDV), which may be more effective than 100 percent SDV, particularly for large, multi-center studies. The monitoring plan needs to ensure quality, data integrity, and risk mitigation. In this session, we will discuss how the new risk-based approach to monitoring affects Clinical Project Managers and their study planning:

• Use of technology for real-time data quality monitoring and targeted SDV assessment

• Identifying high-risk sites: Alignment with EDC; statistical (or algorithm) assessments

• Implications of risk-based monitoring on study conduct: Monitoring resources; SDV plan; site budget/CTA

• A case study with a reduced SDV model

Budgeting and Contracting

9:30 Case Study: Mitigating Risks and Variance when Budgeting and Contracting for a Complex Global Clinical Trial

Allison Burmeister, MBA, Clinical Business Operations Manager, Janssen AI R&D, LLC

The ever-rising cost of conducting clinical trials requires a deep understanding of all of the major cost drivers in drug development. Through the analysis of a complex multinational Phase III study, this presentation provides a detailed look at the major cost drivers in clinical trials. Special attention will be paid to investigator costs and supplier costs which, together, represent ~60% of trial costs. By better understanding these costs, sites, sponsors, and CROs can be better equipped to prevent large amounts of financial risk and variance. The audience will gain a detailed understanding of the key cost drivers in clinical trials. Specifically, they will receive a thorough explanation of the costs specific to clinical sites and to CROs. They will also see a demonstration of tools used when performing financial forecasting for clinical trials, using a complicated Phase III study as an example.

10:15 Coffee Break with Exhibit Viewing

10:30 Sponsored Presentation (Opportunity Available; contact Ilana Quigley,

Clinical Trial Recruitment

10:45 Clinical Trial Recruitment: The Forgotten Majority

Colin Scott, M.D., Senior Director, Clinical Development, Respiratory Franchise, Forest Research Institute, Inc.

Fifty-four percent of U.S. studies do not meet enrollment time lines despite continued efforts to identify patients through intensifying traditional methods. As was first reported in 1995, the typical patients who enters into a clinical trial today is a middle class, affluent, well educated, and white. It appears that traditional recruitment methods are not appropriate for over 60% of the U.S. population who belong to lower socioeconomic groups, many of whom are underserved medically. These patients are the ones who gain most from clinical trial. Very different techniques are required to involve them. These include outreaches through different organizations and functions that deal directly with patients. The messages used to promote participation must focus on what the benefits are from participation, including free regular medical assessment, free multifaceted diagnostic evaluation, free drug, and reimbursement commensurate with fair market value. Patient management must also be much more clearly targeted towards patient satisfaction and the practical realities of life. This presentation will also report on a related pilot being conducted as an adjunct to traditional recruitment methods.

Optimizing Site Performance

11:30 Strategies to Help Optimize Site Performance (Without Them Even Suspecting)

Jan Kosmyna, Clinical Project Manager, Vascular Surgery ARO, The Cleveland Clinic

Project Managers are charged with keeping to tight study timelines, but so much of our work is dependent on forces outside of our control. In this talk your speaker will propose strategies to use with study site personnel to increase productivity, efficacy, and accuracy without creating a chasm of hard feelings between sponsor/CRO/site. This takes a variety and balance of organizational skills, creativity, dedication, a little psychology, and a lot of tenacity. The audience will gain new insights and ideas on how to engage sites with their studies, borrowing from various management and engagement strategies.

12:15 pm Close of Conference

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