R D E HOULD XPERIMENTAL RUGS AND ACCINES FOR BOLA …cafe.usc.edu/storage/1755222144.pdf ·...
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Research Ethics Forum Presented by the Education, Career Development, and Ethics Program (ECDE) of the Southern California Clinical and Translational Science Institute (SC CTSI) Contact: [email protected] RESEARCH DURING AN EPIDEMIC: SHOULD EXPERIMENTAL DRUGS AND VACCINES FOR EBOLA BE PUT THROUGH RANDOMIZED CONTROLLED TRIALS? RESEARCH DURING AN EPIDEMIC: SHOULD EXPERIMENTAL DRUGS AND VACCINES FOR EBOLA BE PUT THROUGH RANDOMIZED CONTROLLED TRIALS? DATE: Friday, December 12, 2014 12:00 PM - 1:00 PM FACILITATOR: Alexander M. Capron Director of Ethics, ECDE, SC CTSI Professor of Law and Medicine, KSOM LOCATION: Norris Research Tower, LG 503/4 1450 Biggy St, Los Angeles, CA Learn more & RSVP: http://bit.ly/1xTOozO In December, researchers plan to begin testing several treatments for Ebola. US-led trials will randomize patients between one group that will receive the drugs being tested and a control group that will get the “standard of care” for Ebola (which includes fluid-replacement therapy, pain relief, and drugs to ward off secondary infections). These trials will take place at the NIH Clinical Center, Emory University, When no proven treatment exists for a deadly disease, do the normal rules apply in research to find ways to cure or prevent it? and the University of Nebraska Medical Center, and possibly Liberia. The investigators chose a random- ized controlled trial (RCT) design both because there can be no certainty that the interventions being tried will prove efficacious or be free of harmful effects and because, if they do seem to provide benefit, the best and fastest way to separate their effects from other causes—including pure chance—is to have a control group. For ethical and practical reasons, Doctors Without Borders, Oxford University and the World Health Organization have refused to follow the standard design for the trials they are launching in West Africa, citing the mortality rate of around 70% among patients who received standard care in West Africa. In testing Ebola vaccines (which have already entered early phase tests), however, WHO plans to run a RCT for the large-scale Phase III trials.
Transcript of R D E HOULD XPERIMENTAL RUGS AND ACCINES FOR BOLA …cafe.usc.edu/storage/1755222144.pdf ·...
Research Ethics Forum
Presented by the Education, Career Development, and Ethics Program (ECDE)of the Southern California Clinical and Translational Science Institute (SC CTSI)
Contact: [email protected]
RESEARCH DURING AN EPIDEMIC: SHOULD EXPERIMENTAL DRUGS AND VACCINES FOR EBOLA
BE PUT THROUGH RANDOMIZED CONTROLLED TRIALS?
RESEARCH DURING AN EPIDEMIC: SHOULD EXPERIMENTAL DRUGS AND VACCINES FOR EBOLA
BE PUT THROUGH RANDOMIZED CONTROLLED TRIALS?
DATE:Friday, December 12, 201412:00 PM - 1:00 PM
FACILITATOR:
Alexander M. CapronDirector of Ethics, ECDE, SC CTSIProfessor of Law and Medicine, KSOM
LOCATION:Norris Research Tower, LG 503/41450 Biggy St, Los Angeles, CA
Learn more & RSVP:http://bit.ly/1xTOozO
In December, researchers plan to begin testing several treatments for Ebola. US-led trials will randomize patients between one group that will receive the drugs being tested and a control group that will get the “standard of care” for Ebola (which includes �uid-replacement therapy, pain relief, and drugs to ward o� secondary infections).
These trials will take place at the NIH Clinical Center, Emory University,
When no proven treatment exists for a deadly disease, do the normal rules apply in research to �nd ways to cure or prevent it?
and the University of Nebraska Medical Center, and possibly Liberia.
The investigators chose a random-ized controlled trial (RCT) design both because there can be no certainty that the interventions being tried will prove e�cacious or be free of harmful e�ects and because, if they do seem to provide bene�t, the best and fastest way to separate their e�ects from other causes—including pure chance—is
to have a control group.
For ethical and practical reasons, Doctors Without Borders, Oxford University and the World Health Organization have refused to follow the standard design for the trials they are launching in West Africa, citing the mortality rate of around 70% among patients who received standard care in West Africa. In testing Ebola vaccines (which have already entered early phase tests), however, WHO plans to run a RCT for the large-scale Phase III trials.
