Ophthalmologists say that participating in a Ophthalmology Clinical Trial can be very rewarding because it allows you to stay on top of the latest therapies and interact with your fellow ophthalmologists as you advance the field together. However, doctors and support staff who have gone through the clinical review process say there are many things to learn that are quite different from how you conduct your day-to-day clinic.
Sometimes you may need to learn a whole new process, while other times you may need to engage in a more intensive version of a process you already do. In any case, experienced clinical investigators say it pays to go in with your eyes open. If you’re considering embarking on the rewarding and challenging journey of clinical trials, here are tips and key questions to consider beforehand to help you hit the ground running.
Doctors who have conducted clinical trials say that the volume of documentation, organization, and attention to detail that goes into conducting a trial places new demands on your current staff and will almost certainly require you to hire someone new as well.
“Tasks like meeting regulatory requirements, systematically documenting things, making sure everything is done by the book, making sure the [Institutional Review Board] approval is right, making sure the patient signs all the consent forms, making sure informed consent is in order. documented, making sure everything is properly dated and timed, and that all personnel are properly certified-it takes a tremendous amount of paperwork and is really a skill in itself,” states Sunir Garg, MD, associate professor of ophthalmology at Sidney. Kimmel Medical College at Thomas Jefferson University. Dr. Garg has experience as a principal investigator in several retinal clinical trials.
“If the ophthalmologist was new to clinical trials, having a clinical trial coordinator or research staff with some research experience and regulatory filings is not only helpful—it’s critical,” he says. “Each patient who comes to the study fills two three-ring binders by the end of the study. If you try to do it yourself out of the gate, it will be very difficult.
Ophthalmology Clinical Trial Coordinator
Vial, Ophthalmology Clinical Trials coordinator for The Cornea & Laser Eye Institute in Teaneck, New Jersey, says first-time clinical investigators are also often caught falling short when it comes to training general staff. “Another thing that is critical in terms of your documentation is staff training in good clinical practice that ensures subject safety and data integrity,” he says. “It is important to understand that all personnel involved in research involving human subjects must undergo training.
This training is sometimes available through your IRB, but can also be done online. The service we use is the online Collaborative Institutional Training Initiative at the University of Miami. In addition, this staff training should be updated every two to three years to ensure and document that all your staff involved in the assessment are properly trained in subject protection. This training is important, and it’s one of the things that doctors may not notice when they go into research because some sponsors assume that your staff has this training and they may not make it clear that it’s needed.”
Training of Staff
This staff training touches on such things as managing the information consent process and protecting subjects’ privacy in terms of how their records are on site. “Staff should have a working knowledge of the protocol, including all procedures that will performe, the purpose of the study, the risks and benefits, and the criteria for selecting subjects,” says Ms. Vial, who adds a tip for practices starting clinical trials. : “What we do here is keep a sort of cheat sheets for each of the studies we participate in. These sheets detail the inclusion/exclusion criteria and diagnostic tests that needs visits to make sure we do not miss anything and to reinforce staff training in the protocol, as sometimes a lot of detail needs to follow. in your head.”
While a doctor may use anticipating problems and taking corrective action in the daily clinic, experts say participating in a clinical trial requires even more in this area. “If some of your study staff don’t have experience doing clinical trials, it can help to simply develop a really strong standard operating procedure manual that breaks down every aspect of the trial,” says Ms Vial. “It’s kind of like a bible that you should follow. It includes everything from the informed consent process and regulatory record keeping to the adverse event reporting process.”
Although ophthalmologists may feel that their staff is capable in a standard clinic setting, they must dig deeper and make staffing decisions against a different set of criteria when they enter the trial process and must assign staffing responsibilities. “For researchers, I would choose some of the better, more detail-oriented technicians,” advises Dr. Garg. “Choose people who are perhaps more curious about new treatments and treatment options, because patients will raise a lot of questions about the study or about diseases in general.
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Even after subjects have been in a study for 18 months, they sometimes ask, “Why am I in this study again?” Having staff who are able to ask such questions is helpful not only in keeping patients motivated, but also in relieving the physician , so that he can concentrate on patient care in general practice and not only in the research unit.”
Discussion with patients
Doctors and study experts say many of the discussions with patients before and during a clinical trial differ from those in the everyday clinic. The ophthalmologist must have a different approach and thought process because patients may come to the study from different perspectives depending on the state of their disease and the effectiveness of their current medications.
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Dr. Garg says you need to adjust your expectations about who can attend a trial because they’re not always the same as who you’d deal with in your office. “Whenever we’re evaluating a patient for possible inclusion in a study like a macular degeneration study, I might think, straight out, ‘I have a million patients with macular degeneration, and it would be super easy to enroll any number of patients in a study,’” he says. “However, studies often have specific inclusion/exclusion criteria, and when you start thinking about your patients in terms of those criteria, the number of patients who qualify for the study may be smaller than you originally thought. This is one difference between regular practice and exam.
Fix the Schedule
“The second difference is time,” continues Dr. Garg. “When you’re in a really busy clinic and you’re two hours behind schedule, often your general bias is to treat someone quickly and get them on their way so you don’t fall behind. But when you’re involve in a research study, discussing the study, getting patients interest, talking to them about potential pros and cons-all of that takes time. In the middle of a busy day, it can be hard to motivate to have such a discussion. But if you’re investing in the clinical trial process, that’s the kind of conversation you have to have, because if you’re not willing to take the time to discuss with patients why they like doing something other than the standard, they’re just not going to like the trial. ”
Doctors say motivation can be a problem for some patients because they may not see the need to enter the study. “If a patient has a disease that they know will make them blind, and you’re doing research in that area to try to find a cure, they’re helpful to the person. in a clinical trial,” says Dr. McLaren.
“But if he’s got a condition that’s causing him vision problems, but you’re actually investigating him for some other reason, or there’s no obvious benefit to the process from what you’re doing, then he’s not going to be anywhere near that. motivated. Given the commitment he has to make, this is understandable. However, in that case, there may be an indirect benefit to the patient that they may not be aware of, so you may want to give them more information about that.
Possibilities of the trial
For example, in a glaucoma clinic, patients may be perfectly happy with the drop they have, but you want them to come in and try a new one in a study. They may not like that, and you can respond, “There may come a time in a few years when you become tolerant or intolerant of your current decline, and we may have to change them or add to your current decline. By approving these new drops in the trial, it may indirectly help you later.’ They need to be aware of that possibility.”
Ms. Vial says the information consent process of a clinical trial, which these patient interviews involve, is much more complex than what doctors use. “Something that isn’t necessarily obvious to a practice starting out in clinical trials is the need to document the entire informed consent process,” he says. “For a clinical trial, it is not enough to just have a signed informed consent document; you must also document the process that surrounds the signing.
Contact the Professionals
When you’re in research, if you’re under investigation by the FDA or the sponsor, the informed consent documentation is the first thing they look at. In practice, we will document the consent discussion after the subject has had an opportunity to review the consent document. A tip we learned from internal audit is to have the subject read the consent and then ask them, ‘Why do you want to participate in this study?’, and then document the key parts of the discussion that follows. You want to demonstrate that the subject truly understands the nature of the research and that they have realistic expectations of what participation would provide them.”
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