Barnett International and Cambridge Healthtech Institute's Clinical Protocol Optimization Conference, part of the Barnett Clinical Summit

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The basis and success of any drug or device development program is the clinical trial protocol. As the protocol is used to directly inform, instruct, guide, or provide a rationale for nearly all study start-up activities and their work products -- including everything from site identification, feasibility and trial registry filing -- it is critical that protocol development is a well thought out and seamlessly executed process. Knowing how to effectively develop a clinical trial protocol is essential to a compound achieving IRB approval, ensuring the success of the study and ultimately achieving market approval, and there is much variability between companies and individuals on how to optimally approach the development of this critical document. At Barnett/CHI’s forum, stakeholders in the protocol development, clinical operations and compliance arenas will come together to discuss strategies to optimize the overall protocol development process.

MONDAY, OCTOBER 3, 2011

11:20 am Conference Registration

Shared Opening Session with Site Performance Management

12:20 pm Organizer’s and Chairperson’s Opening Remarks

Chairperson: Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc

12:30 Protocol Optimization and Its Impact on Site Performance and Site Success

Trifecta Multimedical

Ken Getz, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts University Medical School

This session explores how protocol designs have changed during the past decade and discusses the dramatic negative impact that rising protocol complexity has on clinical trial cycle time, cost and efficiency. Variability by phase and therapeutic area will be presented with insights into targeted areas where protocol complexity is the highest and where it has grown the fastest. The incidence and causes of amendments will also be discussed, along with new data characterizing the prevalence of unused data collected during protocol execution.

1:00 Assessing Protocol Operational Feasibility

Daniela Franschman

Daniela Franschman, Manager, Global Trial Optimization, Merck & Co., Inc.

Collaborate with investigators to provide early input on protocol operational feasibility, with the intention of influencing the design and execution of trials. This insight from investigators helps translate science into practice providing “real-world” practical expertise. Merck has an established process for successfully working with investigators during the development of our protocol design to optimize the trial execution. Learn, through our experience at Merck, the benefit of conducting Protocol Operational Feasibility, specifically through the collaboration with investigators.

1:30 Protocol Complexity: Seven Recipes to Simplify Protocols for Better Study Site Compliance

Manfred Stapff

Manfred Stapff, Senior Director, Clinical Development, Forest

Study protocols have increased in complexity over the past decade. Complicated protocols are a source of errors, lead to increased cycle times, and can cause multiple amendments. When we design a protocol, we should put at least as much effort into feasibility and simplification as we do into scientific integrity. This objective can be achieved by following a few simple rules, defining complexity metrics, and installing appropriate processes during protocol development. Needlessly, complex protocols are a major root cause for time delays, audit findings, and increased costs. Just by avoiding a few “traditional” complexity drivers, significant savings can be realized. The audience will learn how easily protocols can be simplified without loss of scientific quality.

2:00 Panel: Improving the Feedback Loop between Protocol Design and Clinical Operations

A constructive conversation and interactive panel to better understand both sides of a difficult process.

Moderator:

Ken Getz, Senior Research Fellow, Assistant Professor, Tufts Center for the Study of Drug Development, Tufts University Medical School

Panelists:

Daniela Franschman, Manager, Global Trial Optimization, Merck & Co., Inc.

Paul Hoskins, Head, Clinical Operations and Preclinical Outsourcing, Galleon Pharmaceuticals

Amy Ronczka, Senior Clinical Protocol Manager, Global Clinical Operations and Strategy,

Bristol-Myers Squibb
Michelle Marlborough, Senior Manager, Product Management, Medidata Solutions

What are the perspectives and the challenges faced by those scientists and clinicians who design and develop clinical trial protocols?
What are the perspectives and the challenges faced by those in trial operations who then must implement the clinical trial protocols?
How can you create a continuous dialogue to improve processes and outcomes?
How can we learn from each other?
Where is the disconnect and how can it be improved?

2:30 Networking Refreshment Break in Exhibit Hall

3:10 Organizer’s Remarks

3:15 Gathering and Implementing Feasibility Data into Protocol Design: Lessons Learned and Realistic Outcomes

Beth Harper Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc.

As the saying goes, be careful what you ask for. If you ask for input early in the protocol design process you should be prepared to do something with the input to either optimize the protocol or put in place a mitigation plan. In this interactive session we’ll share case examples from some three dozen analyses to see what realistically can and can’t be changed and how this knowledge can shape future information gathering and protocol design practices.

4:00 Interactive Breakout Discussion Groups

Concurrent break-out discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format, please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving and, most importantly, participate in active idea sharing.

TABLE: Strategies for Clearly Defining and Managing the Protocol Development Process

Moderator: Nariman Nasser, Director, Participant Recruitment Service Clinical and Translational Science Institute, University of California, San Francisco

• Selecting sections to address first
• Consistency without redundancy
• Key milestones for circulation and comment on major revisions

TABLE: Lessons Learned from Protocol Amendments and Understanding What Makes a Protocol Unexecutable

Moderator: Beth Harper, Chief Clinical Officer, Centerphase Solutions, Inc

• What are the main “disconnects” between scientifically eloquent studies and operationally unexecutable protocols?
• Data from TUFTS CSDD suggests the majority of protocol amendments can be avoided; how does this compare to your experience?
• Hindsight is 20:20 – based on your recent experiences with amendments, could you have prevented these? What could have helped you avoid these and how will you approach your next study differently?

TABLE: Identifying Key Stakeholders, Integrating Feedback and Monitoring Change Throughout the Research Process

Co-Moderator: Laurie Lebo, Ph.D., CCRP, PMP, Research Services, Vanderbilt University Medical Center

Co-Moderator: Paul Hoskins, Head, Clinical Operations and Preclinical Outsourcing, Galleon Pharmaceuticals

• Who are the key stakeholders of your project/study?
• What is a stakeholder analysis (Interest/Influence Grid)? How do you complete one, and what do you do with the results?
• What is a change control board? Why do you need one?

TABLE: How to Manage the Protocol Development Process with Outsourced Writing Resources

Moderator: Cheryl Vitow, President, Medical Writing and Clinical Management Consulting, CliniQuill Associates, LLC

• How to find a good match for your needs when looking for an external writing resource
• Timing and how it impacts the end result
• Who is running the show when using external resources for writing protocols (CRO or independent medical writer)

TABLE: Complementing Process Improvements with Technology for Protocol Design

Co-Moderators: Suzanne Collins, Director, Operations, Trifecta Multimedical
Co-Moderators: Penny Carlson, Global Clinical Program Manager, Consultant, Genzyme, Inc.

• What changes have you made to optimize the protocol design process?
• What has been the most successful process improvement and why?
• How can the use of technology help you streamline the process?

TABLE: Strategies for Proactive Issues Management and Resolution Strategies for the CRA

Moderator: Kristopher Chrisman, CCRP, Senior CRA, Metabolism & Diabetes/Internal Medicine, US Clinical Research, sanofi-aventis

• What are the tactics in training and retraining?
• Spotting trends with a study and proactively training sites
• Who should be involved with the management of issues and resolution strategies to those issues?

TABLE: Effective Study Site Evaluation Plan Development and Implementation

Moderator: Christopher Beardmore, President and CEO, Oncology, Translational Research Management, LLC

• How do you define the goals and objectives of a site evaluation plan?
• Should goals and objectives apply to a variety of organization types?
• Does conducting site evaluation inherently improve quality?
• Do quality site evaluation plans have common threads to connect organization types?
• How should evaluators be trained to provide consistent site evaluation?

TABLE: New Recruitment Tools are Available, Yet are They Providing Results for the Site and Industry?

Moderator: Joan Chambers, COO, CenterWatch

• New strategies around internet, data mining, matching services, patient databases, and collaborations – is one strategy more effective than others?
• Are these strategies boosting patient enrollment and retention rates? Is there a measurable difference?
• Is convergence of the patient community and industry the strategy for clinical trial success and if so, how is that obtained?

TABLE: Site Relationship Management: Selecting the Right Sites for Your Study

Moderator: Chris Hoyle, M.B.A., Executive Director, Elite Research Network

• Innovative approaches to communicating information to sites in order to make better decisions
• Cost cutting approaches to Sponsor/CRO and site relationships
• Measuring KPIs to improve investigator site selection process.

5:15 Close of Day One

Conference-At-A-Glance