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Clinical Trials

Joe Giffels, MAS, has written extensively on the regulation and practice of clinical research and is here to offer information. Here he shares information and advice on what you should know before, and how to decide if you should volunteer to participate in a clinical trial.

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WebMD Health News

Friday, April 14, 2006

What's the Deal with Northfield Laboratories?
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Apparently, Northfield sponsored a clinical trial of a technology it would like to market - a blood substitute called PolyHeme. The hope is that PolyHeme might be useful in situations where a supply of blood is needed, but is not readily available, such as where a traumatic injury has resulted in a significant loss of blood requiring an immediate, on-site, massive transfusion. The battlefield would be another likely site for this product.

Nineteen clinical trial sites were involved in testing the safety and efficacy of PolyHeme in patients who needed blood as a result of having elective surgery. It was reasonable to assume that such patients would be relatively healthy and able to withstand adverse reactions to the blood substitute, should there be any.

Some of the clinician-investigators at the nineteen sites have complained - to Northfield and publicly - that Northfield has not published the results of the clinical trial, which concluded in 2000. By failing to make all data from the study available to the scientific and medical communities, Northfield is depriving everyone of the knowledge generated by this research. The public good is not well-served when scientific information is generated but not shared.


Next time:
The politics of business and science involved here.

-Joe

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Posted by: Joe Giffels_ WebMD at 6:16 AM

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