E-drug: Ethics of clinical trials (cont'd)
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I'm a community advocate when it comes to clinical trials. I learned
what little I know from AIDS trials in Boston before 1995. I think the
principle of informed consent is profound and not well implemented in
the USA. The perspectives and motivations oftrial participantare not
appreciated, nor adequately investigated. In 1995, our community of
AIDS participants, participation was largely about getting a chance at
getting a treatment that is better than nothing. I imagine in the context
of India a similar context may be operative. It's not an altruistic
motivation for the most part, for participants trials may often be
understood first as treatment not as research questions. For your
trial, have PK studies been done in adults first so you have some
reason to ask the questions for pregnant women and children? PK is
usually associated with phase one I believe along with the safety
concerns; phase II some efficacy. However, in AIDS, we found that
phase I often observed efficacy data as well. All for now. I can't
emphasize enough the importance of participant education,
acknowledgement of participant motivation (and its ambiguities), and
real informed consent.
Michael Immel MPH
Consultant
60 Babcock Street #85
Boston, MA 02446, USA
tel: +1-617-232-4368
e-mail: michaelimmel@hotmail.com
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