5th National Conference on Managing Legal Risks in Structuring & Conducting

Clinical Trials

Wednesday, September 27, 2006

About

"Big Pharma's Shameful Secret"
- headline of Bloomberg Markets article about clinical trials, November 2005

Headlines like this persist despite the recent focus by pharmaceutical, biotech, and medical device companies on increased transparency in clinical trials, and the apparent success of recent efforts to ensure the more vigorous reporting of clinical trial data. And while these industries try to change public perceptions through enhanced disclosure, fears remain that with increased transparency will come increased use of the information by the plaintiffs' bar to initiate new court actions based on ever-more innovative theories.

Yet the trend toward more public information marches on - PhRMA's voluntary disclosure policy encourages disclosure of information about all clinical trials (not just those for serious or life-threatening diseases) and the ICMJE now requires that a clinical trial be registered before a study can be published in a medical journal. States are taking up the issue too, with new and proposed legislation putting further pressure on companies to disclose clinical trial information. And perhaps more importantly, articles like the one run by Bloomberg Markets may put pressure on Congress and the FDA to shift their focus onto human research protections and the clinical trial process itself.

With so much public attention devoted to your work, so many people and organizations involved, and so many medical and legal risks inherent in the process, legal management of your protocols, contracts, consents, and other documents is absolutely critical. In addition, an ever-increasing need to conduct clinical trials overseas presents unique legal challenges and liabilities. You must be able to identify the legal risks and exposures, and effectively structure your trials so as to avoid the bad publicity, fines, and damages that can result if a trial is not conducted properly.

The publication for the American Conference Institute's 5th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials is a collection of presentations given by top industry professionals at the conference.You will get practical, first-hand advice on:

  • Selecting the right investigators and ensuring their compliance with the trial protocol
  • Negotiating and drafting indemnification provisions in a clinical trial agreement (CTA)
  • Countering liability claims through the use of clinical trial data
  • Ensuring that informed consent is a process and not just a form
  • Managing your clinical trials so as to maximize the potential for a successful outcome in the event of litigation
  • Understanding HIPAA and its implications for secondary uses of data or tissue

Contents & Contributors

About

"Big Pharma's Shameful Secret"
- headline of Bloomberg Markets article about clinical trials, November 2005

Headlines like this persist despite the recent focus by pharmaceutical, biotech, and medical device companies on increased transparency in clinical trials, and the apparent success of recent efforts to ensure the more vigorous reporting of clinical trial data. And while these industries try to change public perceptions through enhanced disclosure, fears remain that with increased transparency will come increased use of the information by the plaintiffs' bar to initiate new court actions based on ever-more innovative theories.

Yet the trend toward more public information marches on - PhRMA's voluntary disclosure policy encourages disclosure of information about all clinical trials (not just those for serious or life-threatening diseases) and the ICMJE now requires that a clinical trial be registered before a study can be published in a medical journal. States are taking up the issue too, with new and proposed legislation putting further pressure on companies to disclose clinical trial information. And perhaps more importantly, articles like the one run by Bloomberg Markets may put pressure on Congress and the FDA to shift their focus onto human research protections and the clinical trial process itself.

With so much public attention devoted to your work, so many people and organizations involved, and so many medical and legal risks inherent in the process, legal management of your protocols, contracts, consents, and other documents is absolutely critical. In addition, an ever-increasing need to conduct clinical trials overseas presents unique legal challenges and liabilities. You must be able to identify the legal risks and exposures, and effectively structure your trials so as to avoid the bad publicity, fines, and damages that can result if a trial is not conducted properly.

The publication for the American Conference Institute's 5th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials is a collection of presentations given by top industry professionals at the conference.You will get practical, first-hand advice on:

  • Selecting the right investigators and ensuring their compliance with the trial protocol
  • Negotiating and drafting indemnification provisions in a clinical trial agreement (CTA)
  • Countering liability claims through the use of clinical trial data
  • Ensuring that informed consent is a process and not just a form
  • Managing your clinical trials so as to maximize the potential for a successful outcome in the event of litigation
  • Understanding HIPAA and its implications for secondary uses of data or tissue

Contents & Contributors


SIFTING THROUGH THE LEGAL, PRACTICAL, & CULTURAL CONSIDERATIONS OF CLINICAL TRIALS
Amy Fortenberry, DMF Management Systems

INTERNATIONAL CLINICAL TRIALS
Marc Ginsky, Covance, Inc

SORTING OUT THE PRESSURES TO PUBLICLY DISCLOSE CLINICAL TRIAL INFORMATION
Donald Segal, Alston & Bird LLP

NEW RULES OF THE ROAD FOR CLINICAL TRIALS: BALANCING TRANSPARENCY REQUIREMENTS AGAINST PRE-APPROVAL PROMOTIONAL AND OTHER LEGAL RESTRICTIONS
Leigh-Ann M. Durant, Nixon Peabody LLP

WHAT EVERY IN HOUSE COUNSEL AND RISK MANAGER NEEDS TO KNOW ABOUT CLINICAL TRIAL AGREEMENTS
Alicia Donahue, Shook, Hardy & Bacon
Lee W. Farrow, ACE Medical Risk

MANAGING SPONSOR/INVESTIGATOR RELATIONSHIPS
David Vulcano, Psychiatric Solutions, Inc

MANAGING SPONSOR/INVESTIGATOR RELATIONSHIPS
Michael Swit, The Weinberg Group

CREATING "WIN-WIN" RELATIONSHIPS WITH CROs
Susan Flint, Cato Research Boston
Dennis Lacroix, Genzyme Corp.
Blaine Templeman, Heller Ehrman LLP

ETHICAL & LEGAL UNDERPINNINGS TO ADVERTISE & RECRUITMENT
Julia Manning, AstraZeneca Pharmaceuticals

UNDERSTANDING THE ROLE AND RESPONSIBILITIES OF AN IRB
Cindy Gates, Western Institutional Review Board

IRB LIABILITY
Dr. Francis Miller, Boston University School of Law;
Nutter McClennen & Fish, LLP

INFORMED CONSENT-AUTHORIZATION: OPPORTUNITIES AND CHALLENGES
Jennifer Geetter, McDermott Will & Emery LLP

HIPPA & THE EU DATA PROTECTION DIRECTIVE
Stephen W. Bernstein, McDermott, Will & Emery LLP

CLINICAL TRIALS AND ERRORS
Wayne Bond, Womble Carlyle Sandridge & Rice, PLLC
Jessie C. Fontenot, Jr., Womble Carlyle Sandridge & Rice, PLLC

IDENTIFYING & MINIMIZING LITIGATION RISKS IN CLINICAL TRIALS
Wayne Bond, Womble Carlyle Sandridge & Rice, PLLC
Roxanne Wilson, Reed Smith LLP

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

STRATEGIES FOR ADDRESSING CLAIMS BASED ON PRE- AND POST-APPROVAL CLINICAL TRIAL DATA
Charlene Gallagher, Wyeth Pharmaceuticals

STEERING CLEAR OF PATENT INFRINGEMENT WHILE CONDUCTING CLINICAL TRIALS
James F. Haley, Fish& Neave Intellectual Property Group
Ropes & Gray LLP



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0