Northfield
Responds to ABC 20/20 segment
ABC’s
20/20 report on Northfield’s pivotal Phase III study with
PolyHeme® lacked balance. It failed to note the following key
points:
• It is
critical to conduct rigorous scientific research to improve patient
care and outcomes in emergencies. The PolyHeme study is designed
to address the critical, unmet need for an alternative to blood
when blood may not be immediately available. In the case of a man-made
or natural disaster, PolyHeme represents a potential life-saving
resource to sustain lives that otherwise might be lost.
• This study is
being conducted under a federal regulation passed in 1996. The regulation
allows a waiver of informed consent when patients are in a life-threatening
situation, when obtaining individual informed consent is impossible,
and when current therapy is unproven or unsatisfactory. The most
critical stipulation is that there is the potential for direct benefit
to the patients enrolled: a survival benefit. Northfield’s
trauma study meets these criteria.
• The
study protocol was approved by FDA and by 32 institutional review
boards at
Level I trauma centers across the country.
• Extensive community
consultation was conducted by participating centers, using print
and electronic media, as well as community meetings. Over 60 million
media impressions were created by these efforts.
• An Independent
Data Monitoring Committee is charged with overseeing patient safety
in this study. After reviewing the data on the first 60, 120, 250,
and 500 of the planned 720 patients to be enrolled in the study,
the IDMC four times recommended that the study continue without
modification. Following the 500 patient review, the IDMC recommended
that the study go to completion.
• Northfield
recently announced that the study has passed the 700 patient mark.
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