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2016 ASCRS New Orleans Daily Monday

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EW SHOW DAILY 42 ASCRS Symposia Monday, May 9, 2016 by Liz Hillman EyeWorld Staff Writer How to incorporate rewarding clinical research into your practice P erhaps you already have a busy surgical practice, but have long considered working in clinical re- search. First, you should consider your motivation for wanting to enter the realm of clinical research, said Jay Pepose, MD, St. Louis, said during the Sunday afternoon symposium sponsored by the ASCRS Integrated Practice Committee. "Is it fortune and fame? Be- cause, as you've heard, there is not a lot of fortune associated with re- search. Usually it's not a big practice builder," Dr. Pepose said. "When I think back on some of my heroes when I was a resident and I talk to residents now, they don't even know who these people are. … The fame part is really fleeting. "So I think if you're motivated because of intellectual curiosity, you want to get some early product ex- perience, you like talking and doing research and being at a podium and writing papers, you want to be a part of something that's transformative and changing medicine, you like being with like-minded people who share this, you like being apart of something new … I think those are all very reasonable expectations," he continued. The realities of clinical research are a major of investment in time, training, and staffing. It also means assuming a significant amount of responsibility. "If you don't follow the proto- col you could be fined, you could be disbarred, or you could be impris- oned for misconduct; even if you're not the one doing the misconduct, you're still the captain of the ship," Dr. Pepose said. After making the decision to begin clinical research, Dr. Pepose said everyone on the team should be trained in "good clinical practice," which is required by the Food and Drug Administration (FDA). It's also important to clearly define responsi- bilities of the team. Ahmad Fahmy, OD, Minne- apolis, went through some of the specific roles of a clinical research team in his presentation. These roles include that of a director of research, clinic manager, a clinic coordinator, and technicians. When it comes to subject recruitment for a study, this part of the process can be rather time intensive, and as James Socks, OD, Orange County, California, put it, time is of the essence. "From the sponsor side, rapid enrollment is critical because time is money," Dr. Socks said. Walter Whitley, OD, Norfolk, Virginia, offered some recruitment tips and insights. The first was information from a 2014 Indus- try Standard Research white paper that found about 70% of research subjects are pulled into studies from I N T R O D U C I N G HAPPINESS IN SIGHT New PROKERA ® Clear helps heal the cornea and maintains visual acuity PROKERA ® Clear goes beyond hydration to: Rejuvenate the cornea Simultaneously reduce inflammation and promote quality healing Treat chronic dry eye cases DEWS level 2, as well as levels 3 and 4 NEW See us at ASCRS Booth 1717 SM-267, Rev 2, 4/5/2016

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