Eyeworld Daily News

2016 ASCRS New Orleans Daily Monday

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43 EW SHOW DAILY 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 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

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