Reducing Legal Risks in Promoting & Conducting

CLINICAL TRIALS

Monday, February 09, 2004

About

Is your drug/device development process exposing your organization?

Some 80,000 clinical trials are now conducted worldwide each year, offering much promise for pharmaceutical and medical device companies, and, most importantly, for patients. According to the FDA, however, in the period between 1992 and 2002, complaints related to clinical trials increased over 1000%, indicating the increased exposure to liability faced by pharmaceutical, biotech and medical device companies at the clinical trial stage and beyond. This trend will continue as the number of patients involved in NDAs increases.

Increasingly, plaintiffs are relying on allegations that include decisions made at the various stages of development in an effort to prove lack of efficacy or fraud. Data from clinical trials is used in an attempt to show knowledge of a danger and subsequent negligence or recklessness in the drug company's failing to act appropriately to safeguard the public from such dangers.

With these increasing threats, it is imperative that every in-house counsel, regulatory affairs officer and defense counsel understand the potential risks and have an effective strategy in place to minimize exposure and successfully defend claims. This American Conference Institute publication brought together an experienced faculty of in-house counsel, research officers, senior government officials, congressional representatives and defense counsel to provide you with the practical strategies you need to safeguard your client while it promotes, conducts and monitors clinical trials. These experts will provide an up-to-the-minute guide to the latest litigation, legislative updates and other critical issues, including:

  • Minimizing conflicts on IRBs
  • What does the FDA look for to determine whether there is truly informed consent?
  • Complying with privacy regulations
  • Reducing the likelihood of allegations of fraud in the research
  • Legal strategies for data management
  • Ensuring ethical compliance in clinical trials

Contents & Contributors

About

Is your drug/device development process exposing your organization?

Some 80,000 clinical trials are now conducted worldwide each year, offering much promise for pharmaceutical and medical device companies, and, most importantly, for patients. According to the FDA, however, in the period between 1992 and 2002, complaints related to clinical trials increased over 1000%, indicating the increased exposure to liability faced by pharmaceutical, biotech and medical device companies at the clinical trial stage and beyond. This trend will continue as the number of patients involved in NDAs increases.

Increasingly, plaintiffs are relying on allegations that include decisions made at the various stages of development in an effort to prove lack of efficacy or fraud. Data from clinical trials is used in an attempt to show knowledge of a danger and subsequent negligence or recklessness in the drug company's failing to act appropriately to safeguard the public from such dangers.

With these increasing threats, it is imperative that every in-house counsel, regulatory affairs officer and defense counsel understand the potential risks and have an effective strategy in place to minimize exposure and successfully defend claims. This American Conference Institute publication brought together an experienced faculty of in-house counsel, research officers, senior government officials, congressional representatives and defense counsel to provide you with the practical strategies you need to safeguard your client while it promotes, conducts and monitors clinical trials. These experts will provide an up-to-the-minute guide to the latest litigation, legislative updates and other critical issues, including:

  • Minimizing conflicts on IRBs
  • What does the FDA look for to determine whether there is truly informed consent?
  • Complying with privacy regulations
  • Reducing the likelihood of allegations of fraud in the research
  • Legal strategies for data management
  • Ensuring ethical compliance in clinical trials

Contents & Contributors

POTENTIAL LIABILITY ARISING FROM CLINICAL TRIALS
Harvey L. Kaplan, Shook, Hardy & Bacon L.L.P.
Laurie H. Polinsky, Aventis Pharmaceuticals Inc.

LITIGATION EXPOSURES IN CLINICAL TRIALS: AN INTRODUCTION
James A. O'Neal, Faegre & Benson LLP

ACADEMIC INDUSTRY RELATIONSHIPS IN THE LIFE SCIENCES: IMPLICATIONS FOR ACADEMIC IRBS
Dr. Eric Campbell, Massachusetts General Hospital

OBTAINING MEANINGFUL INFORMED CONSENT AT HOME AND ABROAD
Diane E. Lifton, Gibbons Del Deo Dolan Griffinger & Vecchione, P.C.
Steven Peckman, Office of Protection of Research Subjects, University of California

REPORT FROM HHS WHAT'S ON THE HORIZON
Michael A. Carome, M.D., Department of Health and Human Services

INDUSTRY-SPONSORED RESEARCH: WHAT YOU NEED TO KNOW TO AVOID THE LEGAL PITFALLS
Angela R. Wishon, University of Texas Medical Branch
Elizabeth Gobeil, Solvay Pharmaceuticals, Inc.
Linda Pissott Reig, Porzio, Bromberg & Newman

INDUSTRY-SPONSORED RESEARCH: WHAT YOU NEED TO KNOW TO AVOID THE LEGAL PITFALLS STANDARDS ON COMMUNICATION OF CLINICAL TRIAL RESULTS: "HANDS ON" VERSUS "HANDS OFF" ROLE IN DRAFTING OF MEDICAL LITERATURE & PRACTICAL TIPS FOR PREVENTING UNWANTED ACCESS TO STUDY DATA
Linda Pissott Reig, Porzio, Bromberg & Newman

PRACTICAL STRATEGIES FOR MEETING PRIVACY OBLIGATIONS IN CLINICAL TRIALS
Peter Adler, Foley & Lardner
Christina F. Solis, J.D., The University of Texas, Health Science Center at Houston

A VIEW OF THE LEGISLATIVE AND REGULATORY ENVIRONMENT
Douglas Peddicord, Ph.D., ACRO

SPONSOR/CRO CONTRACTING AND ALLOCATING RISK
James W. Lovett, Covance Inc.

OUTSOURCING: THE LEGAL RISKS AND HOW TO REDUCE THEM
Penny Smith, Solvay Pharmaceuticals, Inc.

A PRACTICAL GUIDE TO NEGOTIATING CLINICAL TRIAL AGREEMENTS
Blaine Templeman, Mintz Levin Cohn Ferris Glovsky and Popeo

ENSURING ETHICAL COMPLIANCE WITH CLINICAL TRIALS
Barbara R. Binis, Reed Smith LLP

MINIMIZING CLINICAL TRIAL LIABILITY THROUGH COMPLIANCE WITH FDA REGULATIONS
Robert B. Nicholas, McDermott, Will & Emery

STRATEGIES FOR INFORMATION MANAGEMENT
Cecelia Gassner, Lifetech Law Group

NOVEL USES OF CLINICAL TRIAL DATA SUPPORTING POST-MARKETING PRODUCT LIABILITY CLAIMS
Hope S. Freiwald, Dechert LLP
Joseph D. Piorkowski, Jr., Shook, Hardy & Bacon LLP

HOW TO PREVENT AND MANAGE PRODUCT LIABILITY CLAIMS ARISING OUT OF CLINICAL TRIALS: INSTITUTIONALIZING INFORMED CONSENT
Amor A. Esteban, Drinker Biddle Reath
Lee Farrow, ACE

PREVENTING AND MANAGING PRODUCTS LIABILITY CLAIMS BASED UPON THE FAILURE TO WARN IN CLINICAL TRIALS
Lori G. Cohen, Alston & Bird LLP
Paula Kosky Hamann, Alston & Bird, LLP

PREVENTING PRODUCT LIABILITY CLAIMS: A RISK ASSESSMENT UPON THE FAILURE TO WARN IN CLINICAL TRIALS
Lee Farrow, ACE
Colleen T. Davies, Reed Smith Crosby Heafey LLP
Amor A. Esteban, Drinker Biddle Reath
James W.A. Ladner, St. Jude Medical, Inc.
Lori G. Cohen, Alston & Bird LLP



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