|
AGENDA
On
Days 1 and 2, workshop participants were provided with
a scholarly assessment of the state-of-the-art regarding placebo
research by biologists, behavioral and social scientists,
epidemiologists, and biostatisticians, who were commissioned
to write background papers. Manuscripts were provided to
workshop participants and were summarized in plenary sessions.
These presentations served as the basis for discussions
in breakout sessions scheduled on Day 3, in which participants
developed recommendations for a future interdisciplinary
research agenda.
| Sunday,
November 19th |
| 3:00
p.m. |
Registration |
|
4:30 p.m.
|
Welcome
and Overview |
| |
| Welcome: |
| Stephen E. Straus, Director,
National Center for Complementary and Alternative
Medicine |
| Josephine P. Briggs, Director,
Division of Kidney, Urologic and Hematologic
Diseases, National Institute of Diabetes and
Digestive and Kidney Diseases |
| |
| Overview: |
| Co-Chairs:
Arthur Kleinman, Harry Guess |
|
|
5:00 p.m.
|
Definition
of the Field and History |
| |
| Presenter:
Anne Harrington,
"Seeing the Placebo Effect: Historical
Legacies and Present Opportunities" |
| Respondents:
Ted Kaptchuk, Robert Rose |
|
| 6:00
p.m. |
Social/Cultural
Aspects |
| |
| Presenter:
Daniel Moerman,
"Meaningful Dimensions of Medical Care" |
| Respondents:
Thomas Csordas, Robert Hahn |
|
| 7:00
p.m. |
Reception |
| 8:00
p.m. |
Adjourn |
|
| Monday,
November 20th |
| 7:00
a.m. |
Registration |
| 8:00
a.m. |
| Welcome
and Overview |
| Co-Chairs:
Arthur Kleinman, Harry Guess |
|
| 8:05
a.m. |
Behavioral
Aspects |
| |
| Presenters:
|
| Shepard
Siegel, "Explanatory Mechanisms of the
Placebo Effect: Pavlovian Conditioning" |
| Richard
Bootzin, "Explanatory Mechanisms of the
Placebo Effect: Cognition, Personality, and
Social Learning" |
| Respondents:
Robert
Ader, Irving Kirsch
|
|
| 10:00
a.m. |
Coffee
Break |
| 10:30
a.m. |
Biological
Aspects |
| |
| Presenter:
Donald Price,
"Biological and Psychological Mechanisms
of Placebo Analgesia"
|
| Respondents:
Gerald Fischbach, Steven Hyman |
|
| 11:30
a.m. |
Lunch |
| 12:30
p.m. |
Implications
of the Placebo Effect for Clinical Trials: Session
I |
| |
| Moderator:
Frank
Rockhold |
| Presenters: |
|
| Robert
Temple, "Use
of Placebo in Clinical Trials: U.S. Regulatory
Perspective" |
| Kenneth
Rothman, "When
is it Appropriate to Use a Placebo Arm in
a Trial?"
|
| Stuart
Pocock, "The
Pros and Cons of Non-Inferiority (Equivalence)
Trials" |
| Audience
Discussion |
|
| 2:00.
p.m. |
Coffee
Break |
| 2:30
p.m. |
Implications
of the Placebo Effect for Clinical Trials: Session
II |
| |
| Moderator:
Janet
Wittes |
| Presenters: |
|
| Robert
Califf, "Use
of Placebo in Large-Scale Clinical Trials" |
| Edward
Davis, "Regression
to the Mean or Placebo Effect?"
|
| John
Eisenberg, "Alternatives
to Placebo Controlled Trials" |
| Audience
Discussion |
|
| 4:00
p.m. |
Break |
| 4:30
p.m. |
Ethical
Aspects |
| |
| Presenter:
Sissela Bok,
"When Does Placebo Use Present Ethical
Problems?" |
| Respondents:
Howard Brody, Robert Levine |
|
| 5:30
p.m. |
Adjourn |
|
| Tuesday,
November 21st |
| 8:00
a.m. |
Summary,
Charge to the Working Groups
|
| |
Co-chairs:
Harry
Guess, Arthur Kleinman
Co-Organizers: Linda Engel, John Kusek |
|
8:45 a.m.
|
Breakout
Groups: Session I |
| |
| Group
2:
|
Use
of placebos in clinical trials to test pharmacological
interventions |
| Co-Chairs |
Kathleen
Propert, David Wendler
|
| Panelists: |
Robert Ader, Rob
Califf, Robert Hahn, Irving
Kirsch, Robert Levine, Frank Miller, Pamela Sankar, Shepard
Siegel, Robert Temple, Charles Weijer |
| |
|
| Group
3:
|
Use
of placebos in clinical trials to test procedural
interventions |
| Co-Chairs: |
David
Feigal, J. Bruce Moseley |
| Panelists: |
Howard Brody, Ed
Davis, Gerald Fischbach, Daniel Moerman,
Stuart Pocock, Kenneth Rothman, Janet Wittes |
| |
|
| Group
5: |
How
can what we know about the placebo effect
be used to explain the purported effectiveness
of some complementary and alternative therapies
and psychosocial interventions? |
| Co-Chairs: |
Susan
Czajkowski, Esther Sternberg |
| Panelists: |
Richard Bootzin,
Margaret Chesney, Carlo Contoreggi, Kenneth
Fox, Richard Gracely, Anne Harrington, Ted
Kaptchuk, Donald Price, Robert Rose, Julian
Thayer, John Weinstein |
|
|
10:30
a.m.
|
Coffee
Break |
|
10:45
a.m.
|
Breakout
Groups: Session II |
| |
| Group
1: |
What research is needed to further elucidate
the nature of the placebo effect? |
| Co-Chairs:
|
Fabrizio
Benedetti, Cheryl Kitt, Michael Stefanek |
| Panelists: |
Robert Ader, Ed
Davis, Gerald Fischbach, Wayne Jonas, Ted
Kaptchuk, Irving Kirsch, Robert Levine, Daniel Moerman, Donald Price, Robert
Rose, Shepard Siegel, Robert Temple, Sabra
Woolley |
| |
|
| Group
4:
|
Use
of placebos in clinical trials to test behavioral
interventions |
| Co-Chairs |
Thomas
Borkovec, Lisa Onken |
| Panelists: |
Guillermo Bernal,
Richard Bootzin, Howard Brody, Louis Castonguay,
Robert Levine, Nancy Petry,
Stuart Pocock, Kenneth Rothman |
| |
|
| Group
6:
|
How
can what we know about the placebo effect
be applied to the patient’s advantage
in conventional medical practice? |
| Co-Chairs: |
Ruth Fischbach, David Spiegel |
| Panelists: |
Walter Brown,
Rob Califf, Robert Hahn, Anne Harrington,
Halsted Holman, Rhonda Moore,
Howard Spiro |
|
| 12:30
p.m. |
Lunch |
| 1:15
p.m. |
Breakout
Group Chairs Report Back |
| 3:15
p.m. |
Closing
Remarks: Harry Guess, Arthur Kleinman |
| 3:45
p.m. |
Adjourn |
|
|