Sousa
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WMA Satellite Meeting
The future of the Declaration of Helsinki
The new Declaration of Helsinki and the use ofThe new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remainsplacebo in clinical trials: controversy still remains
SOUSA, Maria-Sharmila Alina
FRANCO-GHIRALDINI, Mirian Aparecida
MACIEL, Rui Monteiro de Barros
PESTANA, José-Osmar Medina
MASSUD-FILHO, João
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• Declaration of Helsinki – strengthen measures to protect
research subjects
• Letter from Brasilia (2000):
“The Declaration of Helsinki should be maintained as an overall set
of concise principles. Even though the Declaration of Helsinki is
the responsibility of the World Medical Association, the
document should be considered the property of all humanity”
Human, Fluss, 2000
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• 1964 Declaration of Helsinki – worldwide accepted document
1975 (Tokyo)
1983 (Venice)
1989 (Hong Kong)
1996 (Somerset West)
2000 (Edinburgh)
…
2002 (Washington)
2004 (Tokyo)
…
• 2008 Declaration of Helsinki – controversy
(Seoul)
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• DoH (2008) – § 32: “The benefits, risks, burdens and effectiveness of
a new intervention must be tested against those of the best current
proven intervention, except in the following circumstances:
1. The use of placebo, or no treatment, is acceptable in studies where no
current proven intervention exists; or
1. Where for compelling and scientifically sound methodological reasons
the use of placebo is necessary to determine the efficacy or safety of an
intervention and the patients who receive placebo or no treatment will
not be subject to any risk of serious or irreversible harm. Extreme care
must be taken to avoid abuse of this option”.
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• National Committee of Research Ethics (CONEP) :
Resolution 404 (Aug 1st, 2008)
• DoH (2000) : “The benefits, risks, burdens and effectiveness of a new
intervention must be tested against those of the best current proven
intervention. This does not exclude the use of placebo, or no treatment,
where no current proven intervention exists”.
BRAZIL OFFICIAL BAN (2008 … )
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• What are the options for the PLACEBO use debate?
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• What are the options for the PLACEBO use debate?
a) When Placebo IS Acceptable:
Vitamin D Clinical Trial
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• What are the options for the PLACEBO use debate?
a) When Placebo IS Acceptable:
Vitamin D Clinical Trial
b) When Placebo is NOT Acceptable:
Tuskeegee (1972)
HIV Transversal Contamination (1996)
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• What are the options for the PLACEBO use debate?
a) When Placebo IS Acceptable:
Vitamin D Clinical Trial
b) When Placebo is NOT Acceptable:
Tuskeegee (1972)
HIV Transversal Contamination (1996)
c) When Placebo CHANGES Gold-Standard:
CAST (1986) – Cardiac Arrhythmia Suppression Trial
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• Controversy remains – radicalisms
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
ICH
International Conference of Harmonisation
Versus
• Controversy remains – radicalisms
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
ICH
International Conference of Harmonisation
Versus
CFM and CONEP – Brazil
CFM (Federal Council of Medicine)
CONEP (National Committee of Research Ethics)
• Controversy remains – radicalisms
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
ICH
International Conference of Harmonisation
Versus
CFM and CONEP – Brazil
CFM (Federal Council of Medicine)
CONEP (National Committee of Research Ethics)
Declaration of HelsinkiDeclaration of Helsinki
• Controversy remains – radicalisms
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• Declaration of Helsinki – common ground
• Placebo use
a) pragmatic
b) idealistic
NOT!
The new Declaration of Helsinki and the use of
placebo in clinical trials: controversy still remains
• Declaration of Helsinki – common ground
• Placebo use
c) case – by – case
Thank You.