 Re: My clinical trial has been red flagged!
On Feb 2, 12:45 pm, "WhiteSoxFan" <leica...@comcast.net> wrote:
> the other arm (the one with the chemo) has been stopped because of an unusually high> incidence of patients developing lukemia. As he put it, they expected
> 1 out of 500 to develop lukemia and so far its been 3. The study
> number is S9921 conducted by SWOG (southwest oncology group).
>
> WSF
Sox,
Somebody just sent me this. It seems topical. But you would think
protocols for stopping this type of research would already be in
place.
'Unanticipated problems' in trials must be reported, says HHS"
By Kirsty Barnes
31/01/2007 - The Department of Health and Human Services (HHS) has
released
updated guidelines on clinical trial reporting requirements in the US.
>From now on, all "unanticipated problems" occurring in participants of
clinical trials sponsored or supported by the HHS must be reported.
"An unanticipated incident, experience, or outcome will generally
warrant
consideration of substantive changes in the research protocol or
informed
consent process/document or other corrective actions in order to
protect the
safety, welfare, or rights of subjects," says the new guidelines,
released
by the HHS's Office for Human Research Protections (OHRP).
The OHRP stressed, however, that an unanticipated problem should not
be
confused with an adverse event - the vast majority of adverse events
occurring in human subjects are not unanticipated problems.
"Only a small subset of adverse events occurring in human subjects
participating in research will meet the three criteria for an
unanticipated
problem."
According to the guidance, "The OHRP will consider any incident,
experience
or outcome an unanticipated problem if it is of an unexpected nature,
severity or frequency given the research procedures described in the
IRB-approved research protocol or informed consent form and taking
into
account the characteristics of the subject population; if it is or may
be
related to participation in the clinical trial; and if it may place
trial
participants or others at greater risk of physical, psychological,
economic
or social harm than was previously known."
The OHRP did acknowledge the potential difficulties that may be
experienced
when trying to determine whether a particular incident, experience, or
outcome is unexpected and whether it is related or possibly related to
participation in the research. However, it stressed the importance of
doing so and advises that once an unanticipated problem is identified,
those running the trial should consider taking immediate corrective
actions.
These included making changes to the research protocol initiated by
the
investigator prior to obtaining IRB approval to eliminate apparent
immediate
hazards to subjects; modification of inclusion or exclusion criteria
to
mitigate the newly identified risks; implementation of additional
procedures
for monitoring subjects; suspension of enrollment of new subjects;
suspension of research procedures in currently enrolled subjects;
modification of informed consent documents to include a description of
newly
recognized risks; and provision of additional information about newly
recognized risks to previously enrolled subjects."
Honestly, I don't know why this is news. The lawyers are just going
to be busy carving out exceptions to the "unanticipated problems"
definition. Best part of all: It says that if you run into one of
these thorny problems, you should "consider" taking action. Think
about it.
You are lucky that they actually stopped the trial. Some years back,
my husband was asked to participate in a study of an experimental
vaccine for melanoma that was supposed to boost the immune system. It
was to last 5 years. Anyway, people came from all over to
participate; my husband even became friendly with a guy from Holland.
The study was conducted by New York University Hospital, which was
supposed to have the best derm. dep't in NYC. The doctor who
conducted it even managed to have the study written up in People
magazine! It said that everything was hunky dory.
Well, about a 1 1/2 yrs. into the study, they suddenly announced they
were stopping it. Why? They had run out of money.
Now, that really sounded fishy to me. NYU is a very rich institution
and I couldn't imagine them not being able to scrape up enough money
to finish this job. They own a nice chunk of real estate in Lower
Manhattan -- maybe they should just have put up something for sale.
Anyway, I mentioned it to my own doc at the time, and he agreed with
me that it was a bit weird. He opined that maybe participants were
having adverse effects, or that the study wasn't doing what it was
supposed to do. Of course, if any of that were true, they had a duty
to inform the patients.
To this day, I wonder if being in that trial has caused him any ill
effects.
Leah
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