Managing Risks in
Structuring & Conducting

Clinical Trials

Tuesday, February 27, 2007

About

Legislation Regulation Compliance Litigation

Clinical trial exposures, liabilities, and risks have never been more daunting - or more real. The clinical trials provisions of recent proposed legislation will have a major impact on FDA authority to require sponsors to conduct Phase IV studies and maintain clinical trial registries. Recent and rampant litigation, including COX-2 trials, have led to increased demand for more transparency in the clinical research process. Questions still remain on the use, ethicality, and accuracy of adaptive trial design, especially after the FDA's announcement that it is taking steps to help facilitate these types of trials. In addition, penalties for noncompliance with proposed drug safety legislation are looming, and damage awards have never been higher. Finally, negative reports continue to flood the media and plague an industry which does not need more bad press.

The publication from the American Conference Institute's 6th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is specifically designed to provide you with an intensive and thorough review of the critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents. The distinguished faculty who have provided their presentation materials for the publication includes legal and compliance experts from pharmaceutical and medical device companies, CROs, and hospital and research institutions, as well as expert attorneys.

Contents & Contributors

About

Legislation Regulation Compliance Litigation

Clinical trial exposures, liabilities, and risks have never been more daunting - or more real. The clinical trials provisions of recent proposed legislation will have a major impact on FDA authority to require sponsors to conduct Phase IV studies and maintain clinical trial registries. Recent and rampant litigation, including COX-2 trials, have led to increased demand for more transparency in the clinical research process. Questions still remain on the use, ethicality, and accuracy of adaptive trial design, especially after the FDA's announcement that it is taking steps to help facilitate these types of trials. In addition, penalties for noncompliance with proposed drug safety legislation are looming, and damage awards have never been higher. Finally, negative reports continue to flood the media and plague an industry which does not need more bad press.

The publication from the American Conference Institute's 6th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials is specifically designed to provide you with an intensive and thorough review of the critical issues that arise in ensuring proper management of your protocols, contracts, consents, and other documents. The distinguished faculty who have provided their presentation materials for the publication includes legal and compliance experts from pharmaceutical and medical device companies, CROs, and hospital and research institutions, as well as expert attorneys.

Contents & Contributors


CLINICAL TRIALS DISCLOSURE: PHARMA'S PERSPECTIVE
Scott M. Lassman, Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington)

ENSURING COMPLIANCE IN CLINICAL TRIAL DISCLOSURES AND TRANSPARENCY
Jude E. Walsh, Governor's Office for Health Policy and Finance State of Maine (Augusta, ME)

CLINICAL TRIAL TRANSPARENCY
Erika King Lietzan, Covington & Burling LLP (Washington, DC)

REDUCING LIABILITY RISKS IN DISSEMINATING/DISCLOSING CLINICAL TRIAL INFORMATION AND RESULTS
Ralph F. Hall, Baker & Daniels LLP (Indianapolis, IN)

IDENTIFYING AND MINIMIZING LITIGATION RISKS OF CLINICAL TRIAL DATA AND POST-MARKET ADVERSE EVENT REPORTS
Charlene A. Gallagher, Vaccines Wyeth Pharmaceuticals (Philadelphia, PA)

CLINICAL TRIAL DATA IN LITIGATION
Joseph K. Hetrick, Dechert LLP (Philadelphia, PA)

USE OF CLINICAL TRIAL DATA TO COUNTER POTENTIAL POST-MARKETING CLAIMS
Joseph K. Hetrick, Dechert LLP (Philadelphia, PA)

ADAPTIVE CLINICAL TRIALS: POTENTIAL LEGISLATIVE AND REGULATORY BARRIERS
Steven E. Irizarry, ML Strategies, LLC (Washington, DC)

PLANNING AND IMPLEMENTING ADAPTIVE CLINICAL TRIALS & DESIGNS
Jerald S. Schindler, Cytel Pharmaceutical Research (Cambridge, MA)

REACTING TO SCRUTINY OF CLINICAL TRIAL DISCLOSURES BY THE SEC
Elizabeth P. Gray, Foley & Lardner LLP (Washington, DC)

BUILDING AND IMPROVING PARTNERSHIPS AND ALLIANCES WITH CROS
Colleen Cox, PROMETRIKA, LLC (Cambridge, MA)

MANAGING AND COMPLYING WITH CLINICAL QUALITY OBLIGATIONS
Gary C. Messplay, Hunton & Williams LLP (Washington, DC)

TIPS, TRAPS, & TRENDS: INFORMED CONSENT
Tamara J. O'Black, St. Paul Heart Clinic (St. Paul, MN)

TIPS, TRENDS & TRAPS: OPPORTUNITIES & CHALLENGES IN SECONDARY RESEARCH
Jennifer S. Geetter, McDermott Will & Emery (Washington, DC)

MANAGING PATIENT PRIVACY AND SECURITY IN CLINICAL RESEARCH
Aaron Rodriguez, Medtronic, Inc. (Minneapolis, MN)

MANAGING PATIENT PRIVACY AND SECURITY IN CLINICAL RESEARCH
Jennifer Daniels, Blank Rome LLP (Philadelphia, PA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0