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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report (2006)

Chapter: Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005

« Previous: Appendix A Participants and Invited Experts - Between December 1, 2004 and June 27, 2005
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

B
Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005

Workshop Agenda

8:30

WELCOME AND OPENING REMARKS

 

Philip A.Pizzo

Chair, IOM Board on Health Sciences Policy

Dean, Stanford University School of Medicine

 

Gail Cassell

Member, IOM Council and Board on Health Sciences Policy

Vice President, Scientific Affairs and Distinguished Lilly Research

Scholar for Infectious Diseases

Eli Lilly and Company

OVERVIEW & BACKGROUND

8:45

KEYNOTE: IMPORTANCE OF THE PUBLIC TRUST

 

The Honorable John Porter

Partner

Hogan & Hartson, LLP

9:15

STATUS OF IOM BOARD ACTIVITY

 

Philip A.Pizzo

Chair, IOM Board on Health Sciences Policy

Dean, Stanford University School of Medicine

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

PANEL 1: PATIENT/PUBLIC/JOURNAL EDITORS PERSPECTIVE

9:45

PATIENT/PUBLIC NEEDS

 

Marjorie Speers

Executive Director

Association for the Accreditation of Human Research Protection Programs

 

DISCUSSANTS:

Miriam O’Day

Senior Director of Public Policy

Alpha-1 Foundation

 

Sharon Terry

President and CEO

Genetic Alliance

 

Jeanne Ireland

Director of Public Policy

Elizabeth Glaser Pediatric AIDS Foundation

10:00

DISCUSSION

10:15

CLINICAL TRIAL REGISTRY REQUIREMENTS: INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS

 

Harold Sox

Editor

Annals of Internal Medicine

 

DISCUSSANTS:

Catherine DeAngelis

Editor-in-Chief

JAMA

 

Jeffrey Drazen

Editor-in-Chief

NEJM

10:30

DISCUSSION

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

10:45

BREAK

PANEL 2: CURRENT REGISTRY ACTIVITIES

11:00

INDUSTRY PERSPECTIVE

 

Alan Breier

Vice President, Medical and Chief Medical Officer

Eli Lilly and Company

 

DISCUSSANTS:

Alfred Sandrock

Vice President, Medical Research-Neurology

Biogen Idec

 

Frank Rockhold

Senior Vice President and Director, Biomedical Data Sciences

GlaxoSmithKline Pharmaceuticals Research and Development

11:15

DISCUSSION

11:30

U.S. FOOD AND DRUG ADMINISTRATION

 

Robert Temple

Director, Office of Medical Policy

Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration

11:45

DISCUSSION

12:00

LUNCH

1:00

PERSPECTIVES FROM NIH

AND

SURVEY OF DATA IN CLINICALTRIALS.GOV

 

Deborah Zarin

Director, ClinicalTrials.gov

Lister Hill National Center for Biomedical Communications

National Library of Medicine

1:15

DISCUSSION

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

1:30

WORLD HEALTH ORGANIZATION

CLINICAL TRIAL REGISTRY PROJECT

 

Metin Gulmezoglu

Scientist

World Health Organization

1:45

DISCUSSION

PANEL 3: ACADEMIC PERSPECTIVES

2:00

PRESENTER:

P.Pearl O’Rourke

Director, Human Research Affairs

Partners HealthCare System, Inc.

 

DISCUSSANTS:

John Schneider

Chair, Council on Scientific Affairs

American Medical Association

 

Hugh Tilson

Chair, National Steering Committee

Centers for Education and Research on Therapeutics (CERTs)

2:15

DISCUSSION

3:00

BREAK

PANEL 4: CONGRESSIONAL PERSPECTIVE

3:30

PRESENTER:

Kate Reinhalter

Legislative Assistant

Office of Congressman Ed Markey

U.S. House of Representatives

 

Rachel Sher

Health Counsel

Office of Congressman Henry Waxman

U.S. House of Representatives

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

3:45

DISCUSSION

4:00

GENERAL DISCUSSION/AUDIENCE PARTICIPATION

5:00

ADJOURN TO RECEPTION

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Speakers and Panelists


Alan Breier

Vice President, Medical and Chief Medical Officer

Eli Lilly and Company


Catherine DeAngelis Editor-in-Chief

JAMA


Jeffrey Drazen

Editor-in-Chief

NEJM


Metin Gulmezoglu

Scientist

World Health Organization


Jeanne Ireland

Director of Public Policy

Elizabeth Glaser Pediatric AIDS Foundation


Miriam O’Day

Senior Director of Public Policy

Alpha-1 Foundation


P.Pearl O’Rourke

Director, Human Research Affairs

Partners HealthCare System, Inc.


The Honorable John Porter

Partner

Hogan & Hartson, LLP


Kate Reinhalter

Legislative Assistant

Office of Congressman Ed Markey

U.S. House of Representatives


Frank Rockhold

Senior Vice President and Director

Biomedical Data Sciences

GlaxoSmithKline Pharmaceuticals R&D


Alfred Sandrock

Vice President

Medical Research-Neurology

Biogen Idec


John Schneider

Chair, Council on Scientific Affairs

American Medical Association


Rachel Sher

Health Counsel

Office of Congressman Henry Waxman

U.S. House of Representatives


Harold Sox

Editor

Annals of Internal Medicine


Marjorie Speers

Executive Director

Association for the Accreditation of Human Research Protection Programs


Robert Temple

Director, Office of Medical Policy

Center for Drug Evaluation and Research (CDER)

U.S. Food and Drug Administration


Sharon Terry

President and CEO

Genetic Alliance


Hugh Tilson

Chair, National Steering Committee

Centers for Education and Research on Therapeutics (CERTs)

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Registered Workshop Participants


Margaret Anderson

FasterCures


Debra Aronson

BIO


Naomi Aronson

Blue Cross Blue Shield Association


Angela Bates

NIH


Peggy Beat

Cleveland VA


Annetta Beauregard

Eli Lilly and Company


Lisa Begg

DHHS/NIH


Mario Belledonne

Biolab Research


Douglas Boenning

Children’s National Medical Center


Michele Boisse

American Society for Clinical Pharmacology & Therapeutics


Claire Bornstein

Elizabeth Glaser Pediatric AIDS Foundation


Lizbet Boroughs

American Psychiatric Association


Lynn Bosco

AHRQ


Laquitta Bowers

Self-Employed


Steven Brotman

Wyeth Pharmaceuticals


Voncelia Brown

Salisbury University


Mario Browne

University of Pittsburgh Graduate School of Public Health


Suanna Bruinooge

American Society of Clinical Oncology


Kristin Butterfield

American Academy of Pediatrics


Ronald Califre

Novartis Pharmaceuticals Corporation


Scott Campbell

American Diabetes Association


Dolph Chianchiano

National Kidney Foundation, Inc.


Yen-pin Chiang

AHRQ


Anita Cicero

Gardner, Carton & Douglas


Michelle Cissell

JDRF


Mickey Clarke

Washington University

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Elaine Collier

National Center for Research Resources


Sarah Comley

International Observers


Christina Copty

Aspen Systems Corporation


Jennifer Couzin

Science Magazine


Tyler C.Cymet, DO

C/O Sinai Hospital of Baltimore


MaryAnn D’Alessandro

NPPTL


Kevin Davis

National Cancer Institute


Patty Delaney

Cancer Liaison Program, FDA


Don Detmer

American Medical Informatics Association


Jeffrey Dickey

Spriggs & Hollingsworth


Barry Dickinson

American Medical Association


Wei Du

Adolor Corporation


Brenda Evelyn

Food and Drug Administration


Brian Feit

DHHS/HRSA/HAB/DCBP


Lorraine Fitzsimmons

National Institute on Aging


Yolanda Fleming

National Medical Association


MaryAnn Foote

Amgen


Robert Fulcher

American Society of Nephrology


Barbara Galen

Cancer Imaging Program/NCI/NIH


Roger Garceau

Sanofi-Aventis


Edward Garcia

Washington Health Advocates


Kathryn Goettge

NLM Clinical Information Services


Alan Goldhammer

PhRMA


Jennifer Gorman

Office of the Director, NIH


Lakshmi Grama

National Cancer Institute


David Grandison

Meharry Medical College


Donald Greene

Veritas Medicine


Jeffrey Grossi

Johns Hopkins Medicine

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Mary Hager

American Dietetic Association


Kimberly Harris

Education to Advance Cancer Clinical Trials


Lynne Haverkos

National Institute of Child Health and Human Development


Anthony Hayward

NIH


Katerina Herodotou

Novo Nordisk, Inc.


Susan Herold

Consumers Union


Lauren Hetrick

Abbott Laboratories


Nick Ide

National Library of Medicine


Heather Jameson

Research!America


Lindsey Johnson

U.S. PIRG


Nicole Johnson Baker

Director’s Council of Public Representatives, NIH


Cheryl Karol

Hoffmann-LaRoche Inc.


Kenneth Katz

University of Pennsylvania


Mahin Khatami

NIH/NCI


Felix Khin-Maung-Gyi

Chesapeake Research Review, Inc.


Gary Kline

FASEB


Yosuke Komatsu

Otsuka America Pharmaceutical, Inc.


Kristin Kroeger Ptakowski

American Academy of Child and Adolescent Psychiatry


Steven Krosnick

NIH


Michel Krumenacker

Sanofi-Aventis


Selma Kunitz

KAI Research, Inc.


Theresa Lawrence

Department of Health and Human Services


Sue Levi-Pearl

Tourette Syndrome Association, Inc.


Tola Life

Health Resources and Services Administration


Caroline Loew

PhRMA


Laura Lyman Rodriguez

NIH


Nancy Maher

Department of Veterans Affairs

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Michael Manganiello

National Institutes of Health


Richard Manrow

National Cancer Institute


Sherry Marts

Society for Women’s Health Research


Debra McCoy

Arthritis Foundation


Christopher McGowen

Novo Nordisk, Inc.


Paul Meade

Clear Point Health


David Miller

GlaxoSmithKline


Nancy Miller

NIH


Abdulaziz Mohamed

Manchester Health Department


Richard Mowery

National Institute of Dental and Craniofacial Research


Esther Myers

American Dietetic Association


Nancy Myers

PhRMA


John Neylan

Wyeth Research


Martha Nolan

Society for Women’s Health Research


Susan Norris

AHRQ


Laura Nufire

Self-Employed


Joanne Odenkirchen

NIH/NINDS


Sharon Olmstead

Schering Plough


Paul Parry

Abigail Alliance for Access to Clinical Trials


Carol Payne

Department of Housing and Urban Development


JoNell Potter

University of Miami


Karla Price

Epilepsy Foundation


Kate Reinhalter

U.S. House of Representatives


Stephen Rose

Foundation Fighting Blindness


Marcel Salive

DHHS/Centers for Medicare & Medicaid Services


Susan Schiffner

Veterans Affairs


Jeff Schomisch

Thompson Publishing Group


Nanette Schwann

Lehigh Valley Medical Center

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Yvette Seger

FasterCures


Katie Senauer

RTI


Clarissa Agee Shavers

Michigan State University


J.C.Shay

Department of Housing and Urban Development


Sam Shekar

Center for Quality, HRSA


Rachel Sher

U.S. House of Representatives


Juliette Shih

Genzyme


David Silk

Avalere Health


Paul Sirovatka

American Psychiatric Association


Douglas Sporn

Abbott Laboratories


Linda Temple

Regulatory Affairs Professionals Society


Sona Thakkar

Office of Education and Special Initiatives


Roni Thaler

The Center for Information & Study on Clinical Research Participation


Susan Thaul

Congressional Research Service


Phil Thevenet

GlaxoSmithKline


Stephen Thomas

University of Pittsburgh


Terry Toigo

FDA


Cathy Tran

Science Magazine


Tony Tse

ClinicalTrials.gov, National Library of Medicine


Judith Vaitukaitis

NIH


William Vaughan

Consumers Union


Paula Squire Waterman

Office of Research Oversight, Veterans Affairs


Jill Wechsler

Applied Clinical Trials Magazine


Beat Widler

Roche Products Limited


Erin Williams

Congressional Research Service


Reginald Williams

Avalere Health


Marcel Willner

Bristol-Myers Squibb

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×

Marsha Wilson

Gynecologic Cancer Foundation


Kim Witherspoon

National Cancer Institute


Jerome Yates

American Cancer Society

Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 51
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 52
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 53
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 54
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 55
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 56
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 57
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 58
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 59
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 60
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 61
Suggested Citation:"Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005." Institute of Medicine. 2006. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: The National Academies Press. doi: 10.17226/11561.
×
Page 62
Next: Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials... »
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To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry.

The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry.

Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

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