I'm Dr. Steve Cummings. I direct the San
Francisco Coordinating Center and I'm a
senior investigator at the California
Pacific Medical Center Research
Institute and a professor of medicine and
epidemiology at UC San Francisco. We just
wrote a paper in the New England Journal
of Medicine about electronic informed
consent and Internet-based clinical
trials. Doing consent electronically
allows you a number of other
capabilities; for example, you can embed
links in a consent form that allows a
patient to check that link or click that
link and go to a page where they learn
more about the study. It's important as
well to understand that the patient
really comprehends the research since
you are not there talking to the patient
in person. Just as informed consent can
be done electronically and done from
home, clinical trials can also be done
remotely and done from patients' homes. So
the second part of our article is about
Internet-based clinical trials.
Internet-based clinical research is now
done commonly for things like smoking
cessation or weight loss where patients
signs on, gets advice, and then measures
or reports their smoking history or
weight later on. But trials that involve
drugs or nutritional supplements have
been done much less commonly. There are a
few examples that have been successful
and Internet-based clinical trials have
a couple of important advantages: one, it
allows the opportunity for patients to
participate who don't live near
traditional clinical sites where drug
trials are done; and secondly, since
they're done from home without a
clinical site, such trials can be much
less expensive than standard trials. So
I'm going to use an example of a
clinical trial to illustrate
Internet-based trials that is being done
by a young faculty member at UC San
Francisco. It's a trial of melatonin, an
over-the-counter sleep aid
to treat migraine headaches in
adolescents. So imagine in this case the
first step is to reach your patients who
might qualify; you can do that using
medical records, searching medical records
for patients who may have the diagnosis,
and offering them the opportunity to go
to a website, for example, to participate
or reaching out to patient communities,
again online with a link to a website.
And on the website get more information
about the proposed trial, and if there is
interest, the patient may click on an
opportunity to provide informed consent,
informed consent to then give name and
address and some basic information to
determine whether or not they would be
eligible for the trial. I think the
future for Internet-based clinical
trials is very bright. However, only a few
have been published, others are underway,
we need a lot more experience with how
to do them, how to do them efficiently,
and with issues that might arise in the
course of doing drug-based clinical
research online. However, I think that it
has a lot of potential saving money,
making trials more accessible to a
broader range of patients particularly
those who can't get to clinical sites
where such trials would be done. We've
covered these topics -- electronic consent
and Internet-based clinical trials -- in
our article in the New England Journal. I
hope you take the opportunity to read
the article, and if you're interested in
this line of research, I hope that you
consider using electronic consent, and
where appropriate, Internet-based means
to conduct clinical trials.