E-drug: Independent Review in Developing Countries
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Considering the question whether U.S. based independent review requirements
should be retained on research and trials in the developing world, the
following news is of interest.
The Wall Street Journal (12-14-2000 at p. B2) has a story about
SmithKline's trial of Lotrafiban, a new drug intended to reduce
clotting. The Cleveland Clinic trial was stopped because subjects
using the drug were 33% more likely to die from a heart attack than
the control group. The Journal states that, "[A] scheduled safety
check by an **independent monitoring board** done over last weekend
found that 122, or 2.7%, of the 4,599 patients taking the drug died,
compared with 92, or 2.0 %, of patients taking a placebo," (emphasis
added). The Journal reports that
"[the Chief of Cardiology at the Cleveland Clinic who headed up the
study said that], [M]ore than 1,000 patients were already enrolled
in the . . . trial when studies of other [similar] compounds raised
questions about their safety and efficacy.
He said he raised the possibility in August 1999 with SmithKline and
other researchers of stopping the trial then, over concerns about how
well it would work."
"he and other researchers decided then to increase the number of
safety and efficacy checks of the data to make sure the patients
weren't put at undue risk for participating in the study. 'The hope
was that any [lack of benefit] would show up before any excess
in mortality,' [the doctor] said. 'It all showed up together,' in the
review that prompted the halt to the study."
This story reflects how important independent review is in clinical
trials. In this trial, things went wrong even with independent review
of a trial carried out at one of America's most prestigious clinics.
It demonstrates the combination of high stakes, uncertainly, and
management complexity involved in running a trial safely. Many
developing countries lack the ability to provide *effective*
independent review. And their people are more vulnerable and less
able to protect themselves. If there is a change in U.S. based
independent review requirements, this story shows they should
be more strict. Not eliminated.
Scott D. Hillstrom, J.D.
scott.hillstrom@analyticorp.co.nz
+(651) 452-6003; Mobile +(612) 730-5884; Fax (312) 803-0175
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