Clinical Trial Disclosure: Learning the Landscape and Reading the Roadmap DIA November 13-14, 2007 Hyatt Regency Bonaventure, Weston, Florida

Collaboration of SIACS This program was developed as a cooperative effort by the following DIA Special Interest Area Communities: Good Clinical Practices & Quality Assurance: Clinical Trial Disclosure Working Group Clinical Research Regulatory Affairs Medical Writing

5 Co-Located DIA Conferences 4 other co-located DIA meetings Publication Writing and Building Partnerships DIA Outsourcing Summit The Future of Project Management Winning Strategies for Achieving a Quality EDC Clinical Trial Process Delegates can attend sessions in any of the five conferences Common plenary session and networking events

5 Co-Located DIA Conferences November 13-14, 2007 Weston, Florida (Fort Lauderdale area) Hyatt Regency Bonaventure Conference Center and Spa Keynote Address: Drug Development as a Business: The Role of Outsourcing Harold Glass, PhD, Professor, Health Policy, University of the Sciences in Philadelphia

Clinical Trial Disclosure Working Group Mission To provide a professional, neutral forum for members to discuss and share operational best practices, and medical, scientific and regulatory information related to registry and results disclosure activities. To publicize the field worldwide; stimulate members to engage in the evaluation of registration and data disclosure issues worldwide; and to encourage dialog on registration and results disclosure processes and issues among regulators, registrars, academic institutions, industry, and other stakeholders. To create, publish, and promote materials on registry and results disclosure issues and topics and provide educational opportunities including webinars and workshops under DIA auspices.

Acronyms AAMC: Association of American Medical Colleges CTR: Clinical Trial Registry FDAMA: Food and Drug Modernization Act FDARA: FDA Revitalization Act FACT Act: Fair Access to Clinical Trials Act ICMJE: International committee of Medical Journal Editors IFPMA: International Federation of Pharmaceutical Manufacturers and Associations IOM: Institute of Medicine NIH: National Institutes of Health PhRMA: Pharmaceutical Research and Manufacturers of America WHO: World Health Organization ICTRP: International Clinical Trials Registry Platform

Public Disclosure of Trial Information Clinical Trial Life Cycle Part 1: Register Protocol Information Part 2: Post Trial Results One year after trial completion: Marketed drugs At trial initiation Publicly accessible web site clinicaltrials.gov Publicly accessible web site clinicalstudyresults.org

Clinical Trial Disclosure Landscape Inputs PhRMA AAMC IFPMA AMA Ottawa Grp Countries FDAMA-113 NIH Congressional Acts ICMJE IOM WHO-ICTRP States Publicly Accessible Web sites Users Systematic Reviewers (Cochrane, Oregon) Health Policy Makers Journal Editors Researchers & Funders Consumer Advocates

Current Disclosure Law/Guidance Registration Law FDAMA 113 (serious, life threatening indications) Best Pharmaceuticals for Children Act (expanded access trials) State of Maine (hypothesis- testing trials) International Law Guidance ICMJE PhRMA IFPMA WHO Results Disclosure Law State of Maine Guidance PhRMA IFPMA

Purpose of Trial Disclosure Conference This conference will provide practical advice from industry practitioners for complying with worldwide regulations for public disclosure of clinical trial information. Individuals delivering this conference work inside the industry, ensuring company compliance with laws, regulations and other requirements governing the public disclosure of clinical trial information.

Chairpersons for Trial Disclosure Conference Barbara Godlew, RN Associate Director, Publication Coordination and Transparency Compliance Exploratory Development Communications Novartis Pharmaceuticals Corporation Pamela Rose, RN, BSN, ASQ-CMQOE Director Clinical Trial Information Registries TAP Pharmaceutical Products Inc.

Agenda for Trial Disclosure Conference Session 1: Clinical Trial Landscape and Lifecycle: The Relationship Between Disclosure and the Trial Publication Plan Session 2: Stakeholder Street Maps: A Worldwide Overview to Clinical Trial Disclosure Session 3: After the Trial is Completed: What, When, Where, and How to Post Trial Results Session 4: Reading and Following the Road Map: Public Registration of Clinical Protocol Information

Agenda for Trial Disclosure Conference Session 5: Herding Cats Through Canyons: Developing a Company Process for Public Disclosure Session 6: Are You Ready? Preparing for Audit of Clinical Trial Disclosures Session 7: “Emeralds of Experience”: Clinical Trial Disclosure Lessons Learned

Clinical Trial Landscape and Lifecycle: The Relationship Between Disclosure and the Trial Publication Plan Session Co-Chairs: Barbara Godlew, Novartis Robert Paarlberg, UCB

Session Overview Examine some of the aspects clinical teams should consider when writing a study protocol as well as identifying key stakeholders to include in the publication planning process. Gain knowledge of how patients, families and advocates view public disclosure of clinical trial information. Learn how public disclosure of clinical trial information may impact publication planning.

Speakers Landscapes and Lifecycles: From the Perspective of the Publication Plan Barbara Godlew Robert Paarlberg From the Editor’s Desk: How Much is Too Much? Paul Ladenson, MD, Editor-in-Chief, The Journal of Clinical Endocrinology & Metabolism The Path Towards Access and Transparency: The Patient’s Point of View Pat Furlong, President, Parent Project Muscular Dystrophy

Stakeholder Street Maps: A Worldwide Overview to Clinical Trial Disclosure Session Co-Chairs: Gerard Lynch, AstraZeneca Michael Rubison, Abbott

Clinical Trial Transparency The primary vehicles used to provide transparency are the Registration and Result Disclosure of Clinical Trials. Leading global databases and portals include: ClinicalTrials.gov ClinicalStudyResults.org IFPMA.org WHO Search Portal (ICTRP)

Disclosure Legislation and Public Policy This session provides a chronological history of Clinical Trial Disclosure, key milestones and issues, including: FDAMA 113 legislation of serious and life-threatening diseases and conditions US Federal and state legislation and International statutes Industry Agreements by IFPMA, PhRMA, EFPIA and JPMA Policies and Guidelines from Journal Editors (ICMJE) WHO Reporting, Disclosure and Registry Standards

Speakers Key Milestones and Issues: A Chronological History of Clinical Trial Disclosure Gerard Lynch, Project Leader, Clinical Trials Website, AstraZeneca Michael Rubison, Senior Director, Global Medical Research and Registration, Abbott

After the Trial is Completed: What, When, Where, and How to Post Trial Results Session Co-Chairs: Tracy J Beck, PhD, Global Medical Business Office Consultant, Eli Lilly and Company Milen Vrabevski, MD, CEO, Comac Medical Ltd.

Posting Trial Results The biopharmaceutical industry has used clinical trial registries and results databases as one way to increase clinical trial transparency and public trust. Up until recently, the emphasis has been on registering trials at initiation, but now the focus has shifted towards disclosing results. This session will examine external stakeholders who are shaping the landscape of trial disclosure and what potholes to look out for. Attendees will learn what, when, and how to post results summaries, as well as how to avoid risks of off-label promotion when creating the summaries for public disclosure.

Speakers Brief Overview of Posting Clinical Trial Results Pamela Rose, RN, FNP, ASQ-CMQOE, TAP Pharmaceutical Products Inc. What, Where, and How to Post Results Tracy Beck, PhD, Eli Lilly and Company How to Avoid the Risks of Off-Label Promotion in Results Summaries Bob Naidus, JD, Novartis Pharmaceuticals

Reading and Following the Road Map: Public Registration of Clinical Protocol Information Session Co-Chairs: Maureen Strange, Eli Lilly and Company Barbara Godlew, Novartis Pharmaceuticals

Presentation 1: Finding and Unfolding the Map: Legislation Surrounding ClinicalTrials.gov Clarity on Federal Legislation – a compliance compass Industry is NOT alone, NLM has challenges TOO! Presentation 2: YES! You Can Register a Trial to ClinicalTrials.gov Without a Global Positioning System and We’ll Show You How!! A tutorial build of a registration record in the Protocol Registration System (PRS) Your questions answered

Speakers Rebecca Williams, PharmD Annice Bergeris Assistant Director, ClinicalTrials.gov National Library of Medicine Annice Bergeris Information Research Specialist

Herding Cats Through Canyons: Developing a Company Process for Public Disclosure Session Co-Chairs: Margaret M. Cobb, MD, PhD, Johnson & Johnson Patricia Teden, MBA, Independent Consultant

Needs and Decisions Business Context Multiple study registries and results databases; rules are still changing so the business process needs to be flexible High visibility; premium put on accuracy, completeness, consistency and timeliness Needs and Decisions Create corporate standards for clinical trial disclosure (which studies, which registries, partnership studies, etc) Define process that leverages current clinical trial process and company technology. Enable process with technology? Define roles & responsibilities. Centralized vs. decentralized operations. Use of external resources? Define management oversight and quality steps Create and execute implementation plan

Speakers Large Pharma Perspective BioPharm Perspective Margaret M. Cobb, MD, PhD Senior Director, Global Leader, Clinical Registry Johnson and Johnson Medicines and Nutritionals BioPharm Perspective Anthony K. Taylor, Sr. Clinical Operations Coordinator Targanta Therapeutics Corporation Device Company Perspective Lisa Griffin Vincent, PhD, MA Senior Director, Corporate Clinical R & D Medtronic Inc.

Are You Ready? Preparing for Audit of Clinical Trial Disclosures Session Co-Chairs: John C. McKenney, SEC Associates, Inc. Pamela Rose, TAP Pharmaceutical Products Inc.

Audit of Clinical Trial Disclosures It is becoming increasingly important to ensure that your trial registrations and results postings are accurate, complete, and timely The State of Maine regulations and the FDA Revitalization Act bill pending in Congress include penalties for non-compliance Public image and liability concerns are also strong drivers for companies to ensure they are doing it right This session includes an overview of the fundamental components of a clinical trial disclosure (CTD) audit The heart of this session consists of a panel discussion featuring industry professionals who have participated in CTD audits as auditors/auditees

Panelists Auditee Perspective Shawn M. Pelletier, Associate Director R&D Operations Bristol-Myers Squibb Company Valerie V. Phillips, MA, Manager Clinical Trial Disclosure Pfizer Inc Auditor Perspective John C. McKenney, President & CEO SEC Associates, Inc Beat E. Widler, PhD, Global Head of Clinical Quality Assurance F. Hoffmann-La Roche

Emeralds of Experience Session Chair: Mary Kuskin, RPh Pharmalink Consulting 33

Avoiding Accidents: Clinical Trial Disclosure Lessons Learned Opportunity to share experience 15 minute presentation at the podium Practical examples to help others navigate the clinical trial disclosure field Topics include those presented at the workshop 34

Topics Clinical Trial Disclosure Law How to follow the road map Process for posting after trial completion Registration and the Publication Plan Developing a company process Preparing for audit of public disclosure process 35

Guideline for Abstract Submission All entries must be submitted online http://www.diahome.org/DIAHOME/GetInvolved/AbstractSubmissionLauncher.aspx Deadline for submission is Sept 17, 2007 36

Questions and Answers