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Join the largest
subspecialty society
representing the fields
of cornea and external
disease.
Member Benefits
• Cornea: The Journal of Cornea
and External Disease and Cornea
Society News
• Annual Meetings: Select
discounted registration at
membership events and
educational programs
• Exclusive eligibility for the
International Corneal Training
Grant Program ~ Cornea ED
• Kera-net: The online forum for
the exchange of clinical and
scientific information
Save the Date
World Cornea Congress VIII
Singapore 2020
July 8-9, 2020
www.CorneaSociety.org
Dr. Pepose provides tips on what it takes to start a clinical research program in a practice.
their doctors. Even though that's
clearly the majority, Dr. Whitley
said "you can't just do internal
recruitment." He recommended
using patient networks, advocacy
groups, and databases, as well as
putting marketing materials out in
the community to find interested
participants.
Dr. Pepose offered quite a few
"don'ts" to help with the success
of establishing a clinical research
practice as well. These included
don't over-delegate, don't erase
or white out original data entries,
don't backdate signatures or con-
sent forms, don't forget to obtain
Institutional Review Board approval
for marketing materials and consent
form revisions, and don't revise your
protocol without sponsor approval.
In addition to all of these
tips, Dr. Pepose and other speak-
ers emphasized the importance of
starting small, not taking on too
much research at the beginning.
Kevin Waltz, MD, Indianapolis, said
that those new to clinical research
should avoid attempting a phase
3 trial, which is more rigorous and
under more scrutiny by the FDA,
and might consider a phase 4 trial
instead.
"These are not pivotal trials
but they are furthering marketing
expansion studies," Dr. Waltz ex-
plained, adding later in his presenta-
tion that these types of studies allow
you to "test yourself on less chal-
lenging studies before you go into
the big leagues."
David Geffen, OD, San Diego,
said that 1 of the big advantages of
being involved in clinical research
is the opportunity to get technology
first in a community.
"The ramifications of partici-
pating in studies will trickle down
to the rest of your practice. They
are fun and they keep life exciting,
and I would encourage you to try
to participate in them," Dr. Geffen
said. EW