Request for Question Clarification by
markj-ga
on
14 Feb 2005 14:15 PST
scriven --
I think that I have found the regulations you are looking for. However,
it is possible that more than one governmental proceeding has adopted
language that is relevant to the general subject of your question.
Under the circumstances, I will post the relevant portion of the
regulations I have found and rely on you to respond to this "Request
for Question Clarification" by telling me whether this regulation is
what you remember. If it is, I will post the information (along with
a full citation) as an official "Answer," since that is the only way I
can claim the fee for the research. If it is not, I would be happy to
continue the search.
Here is the regulatory language:
"When a new treatment is tested for a condition for which no effective
treatment is known, there is usually no ethical problem with a study
comparing the new treatment to placebo. Use of a placebo control may
raise problems of ethics, acceptability, and feasibility, however,
when an effective treatment is available for the condition under study
in a proposed trial. In cases where
an available treatment is known to prevent serious harm, such as death
or irreversible morbidity in the study population, it is generally
inappropriate to use a placebo control. There are occasional
exceptions, however, such as cases in which standard therapy has
toxicity so severe that many patients have refused to receive it.
"In other situations, when there is no serious harm, it is generally
considered ethical to ask patients to participate in a
placebo-controlled trial, even if they may experience discomfort as a
result, provided the setting is noncoercive and patients are fully
informed about available therapies and the consequences of delaying
treatment. Such trials, however, even if ethical, may pose important
practical problems. For example, deferred treatment of pain or other
symptoms may be unacceptable to patients or physicians and they may
not want to participate in a trial that requires this. Whether a
particular placebo controlled trial of a new agent will be acceptable
to subjects and investigators when there is known effective therapy is
a matter of investigator, patient, and institutional review board
(IRB)/ independent ethics committee (IEC) judgment, and acceptability
may differ among ICH regions. Acceptability could depend on the
specific design of the trial and the patient population chosen, as
will be discussed below (see section 2.1.5).
"Whether a particular placebo-controlled trial is ethical may in some
cases depend on what is believed to have been clinically demonstrated
under the particular circumstances of the trial. For example, a short
term placebo-controlled trial of a new antihypertensive agent in
patients with
mild essential hypertension and no end-organ disease might be
considered generally acceptable, while a longer trial, or one that
included sicker patients, probably would not be.
"It should be emphasized that use of a placebo or no-treatment control
does not imply that the patient does not get any treatment at all. For
example, in an oncology trial, when no active drug is approved,
patients in both the placebo or no-treatment group and the test drug
group will receive needed palliative treatment, such as analgesics,
and best supportive care. Many placebo-controlled trials are conducted
as add-on trials, where all patients receive a specified standard
therapy or therapy left to the choice of the treating physician or
institution."
Is this the language you remember seeing? I look forward to your response.
markj-ga
