My sister Lili is one of thousands of cancer patients participating in clinical trials at the University of Miami.
When the Miami Herald reported today that the FDA is investigating an undisclosed trial there her husband Bill Cunningham had this reaction - “My immediate thought was is this my trial? Is there something I should know or be doing differently? Is there something to be concerned about?"
There are 230 ongoing clinical trials at Sylvester Comprehensive Cancer Center, more than any other institution in South Florida . No new patients are being enrolled in these trials until further notice. The University would not comment on camera nor reveal which specific trial had problems.
In a written statement, UM claims it has voluntarily implemented a “temporary time out” for enrollment of new patients to conduct a scrupulous review of all similar procedures and that no unfavorable clinical outcomes have been identified.
And they have corrected the issues they reported to the FDA.
“I mean it’s not clear they say they’ve taken care of it but it’s not clear to me what kind of problem it is” says Bill. “Is it administrative or related to the drugs people are getting”
Principal investigators at Sylvester are continuing treatments and follow up care with patients who are already in trials.
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Lili is happy she enrolled before the so-called time out.
It’s unclear how many cancer patients have been trying to get into one of these experimental treatment programs and have been unable to for weeks.
