Perseverance, personnel needed to begin clinical trials
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Clinical trials are an integral part of learning new techniques, discovering new treatments and advancing the field of medicine.
They can also be an important pathway for physicians to advance their career and profile within their specialty.
Source: Jennie L. Scott Photography
“The reason we do clinical research in our practice is to move the field of ophthalmology forward,” OSN Cataract Surgery Section Editor Nicole R. Fram, MD, said. “My partner and mentor, Sam Masket, MD, would always say, ‘What’s good for the patient is good for the doctor and, therefore, good for industry.’”
The knowledge and connections gained from being an investigator are just a few of the incentives a physician can earn from being part of a study, but breaching that area of medicine might seen like a daunting prospect.
OSN Associate Medical Editor William B. Trattler, MD, was invited to take part in his first trial about 20 years ago and has been involved in about 75 trials since then.
“I was invited because of my surgical skills,” he said. “A representative from an IOL company, Bruce Bartlett, recognized me and said, ‘You’d be great for this upcoming clinical trial on a phakic IOL.’ That was the beginning of my experience with clinical trials.”
OSN Refractive Surgery Board Member Vance M. Thompson, MD, started in research during his fellowship in 1990 with a study on PRK.
“That led to me being a PRK investigator in South Dakota, and I started my research center in 1991,” he said. “Doing subspecialty training in a center that does research can be a great way to start that journey. It gives you a year of experience before going into private practice.”
Fram had her first trial experience in 2008 when she was working with Masket, who was heavily involved in FDA and investigator-initiated trials.
“It was fascinating because I didn’t know that I had an aptitude for clinical research until I joined his practice,” she said. “His enthusiasm for research was contagious, and I felt compelled to contribute through clinical research.”
Getting started
When a young physician is looking to participate in trials, Thompson said there are support systems in place to help them get started.
“If you’re in practice and want to get started, it can be very helpful to talk to someone who has done it and to have a mentor,” he said. “Go visit a center that does research, and it’s amazing the support that’s out there.”
Another place to look for help is clinical research organizations (CROs), which serve as intermediaries between industry and physicians who want to do research.
“Organizations like ASCRS, AAO and even the FDA can be very helpful,” Thompson said. “There is a plethora of rich information on the FDA’s website to learn from and that can help you prepare for a career in trials.”
Even if a physician does not initially have all of the connections they need to work with a company-sponsored clinical trial, they can start their own investigator-initiated trial. Trattler said these can be simple, such as looking at patient outcomes after surgery.
“Let’s say you want to look at your patients who have undergone a MIGS procedure,” he said. “You might look at 30, 50 or 100 patients to explore a certain interest or a goal.”
Trattler said he recently involved a medical student who was looking to gain research experience in a toric IOL outcome study.
“We performed a toric IOL outcomes analysis, and the results will be presented at ARVO 2022,” he said. “That’s one way to get study experience, by looking at your results in detail, and from there, you can scale up to prospective studies that involve patients.”
With that shift comes more requirements and more responsibilities. Prospective trials or anything that requires testing on human participants is likely to require oversight from an institutional review board (IRB). According to the FDA, IRBs are designated to review and monitor biomedical research and have the authority to approve, disapprove or require modifications for that research. They are in place to ensure patient rights and welfare are protected.
“IRBs make sure that studies are conducted properly and that patients are provided proper prior informed consent,” Trattler said. “They have final say to ensure a study is done ethically with patient safety and well-being at the forefront.”
Understanding how an IRB functions and working within IRB-approved protocols are important, Nandini Venkateswaran, MD, said. Another crucial part is for aspiring investigators to speak up and express their interest, she said.
“You can never assume that anyone will know that you’re interested in participating in research unless you say it,” she said. “That could mean talking to your sales reps, who can put you in touch with the medical science liaisons of companies, or just taking time to visit company booths at meeting exhibits and introduce yourself as someone who has an interest in pursuing clinical trials.”
Fram said young physicians can put in the work to partner with industry and show that they are not just a customer of their products but also a partner.
“By reviewing your own data, you can craft an abstract and maybe even present it at a conference,” she said. “By doing that, you’re demonstrating to your colleagues and industry that you understand the value of their products to your patient population. Early on in my career, I performed many investigator-initiated trials even if they were unfunded. This helped me develop a reputation of being data driven and ethical.”
Integrating into practice
Participating in a clinical trial takes a lot of work for the physician as well as the entire practice. In company-sponsored trials, there can be a significant amount of paperwork and other requirements added to a practice’s workload.
For smaller practices or younger physicians just starting out, Trattler said it might be practical to have a technician or another employee putting in extra work on trials.
“You have to have someone who is organized and detail oriented and can help you as a go-between, helping your team coordinate with the company as well as the IRB,” he said. “If you start to scale up, your practice will require full-time help. There’s a lot of sensitive paperwork that can be onerous for your team to add to their schedule.”
When OSN Technology Board Member Jodi I. Luchs, MD, was getting started with his first trial, he got a bit lucky. One of the technicians on staff had previous experience at an academic institution and was able to make an easy transition into a role as a research coordinator.
“We were able to provide very clean data,” he said. “That sort of gets the ball rolling, and companies can see that you are a site that meets their quota, does it on time and with few issues or protocol variations.”
Keeping this commitment to quality requires constant upkeep for a practice, particularly when it starts to take part in more clinical trials. Staffing has to keep pace to ensure the center is still providing the same solid data for studies.
“You need to have the infrastructure in terms of proper equipment and procedures in place,” Luchs said. “You also need the proper staff. That might mean support staff, research coordinators or even ODs who are exclusively involved in your research team. That infrastructure can allow you to do more complex and involved trials and show CROs that you have what it takes.”
All of this can amount to a major investment.
“We have 10 full-time people on my research team,” Thompson said. “It’s about a willingness to make a commitment in your practice, in terms of both people and space.”
Coordinating all these team members and protocols is essential to integrate clinical trials into practice. The whole process takes dedication.
“One needs to have a system in place on how to identify which patients are study patients and which ones are not,” Venkateswaran said. “You have to help educate your staff on how to identify adverse events and keep track of things that need to be reported to the IRB and/or sponsor. Lastly, you need to educate patients in a way that empowers them. Patients can actually get pretty excited by the fact that they’re part of a study and contributing to the advancement of the field.”
Making connections
It can take a lot of time and effort to break into the world of clinical trials, but that effort can be paid back with a higher profile and more opportunities later in a career. Face time at conferences is an invaluable tool for an early-career investigator, Trattler said.
“The big meetings, like ASCRS and AAO, are good places to start,” he said. “But even at the smaller meetings, you’re going to be able to connect with company representatives and let them know you’re interested, whether it’s to be part of an upcoming clinical trial that they’re running or your own investigator-initiated trial.”
Those relationships are valuable throughout a career in research, and they take just as much work to maintain as they do to develop, Luchs said.
“It takes a lot of initiative,” he said. “You need to get very friendly with your drug reps, as well as people at the higher levels of the company. Whether it be by speaking or consulting, it’s important that you show them that you’re interested.”
Luchs has also made a habit of making connections with people in CROs. He said CROs are constantly looking for quality research sites.
“You can make these connections, let them know your credentials and get noticed as a good site for them to consider,” he said. “It’s a two-way street. You have to be friendly to industry in order for them to embrace you as a potential partner in development.”
Benefits
The hard work of forging relationships, in addition to the work on clinical trials, can ultimately be recouped in the form of a higher profile for physicians. That could mean more recognition and highly sought after speaking spots at major conferences.
Trattler said his work as an investigator has provided him with many career opportunities. More importantly, however, it has also changed his approach to patient care.
He recently had the chance to take part in a study of TP-03 (Tarsus Pharmaceuticals), a therapeutic designed to treat Demodex blepharitis. What he learned in that study altered how he looked for this condition.
“The study had such a surprising result. I wasn’t aware that collarettes were so common in patients, as you have to have the patient look down to evaluate the base of their upper eyelashes,” he said. “Now, I look for it much more closely, even in asymptomatic patients. Research allows you to learn as a doctor, take better care of your patients and then pass that information on to your colleagues so that they can take better care of their patients.”
The process can be gratifying for physicians. Luchs said being involved in clinical trials has given him the feeling of being on the cutting edge of technology and medicine. It has also given him the opportunity to offer patients a chance to be exposed to new products that are not yet commercially available.
“They love the fact that they know they’re on the cutting edge,” he said. “While the whole process is masked, it can be interesting from an academic standpoint to see how they are improving or not improving. You’re playing a real active role in the development of new medications that could potentially help millions of people in this country.”
Being at the forefront of new research creates a positive public image for a practice. Fram said pushing herself and her practice to constantly learn new things has been an important goal throughout her career. Part of that is a goal to adopt three new techniques and technologies per year.
“That’s the bar I’ve set for myself and all the physicians in our practice to ensure we are at the leading edge of our field,” she said. “You have to understand why you’re doing what you’re doing when you take on a clinical trial. The reason why we do clinical research in our practice is to help clinicians answer relevant questions and improve patient care.”
As long as the study personnel are organized and supported, Fram said that research can also help make a practice financially viable.
“By being involved in funded clinical trials, you can add another revenue stream to the office,” she said. “Initially, you can start building with a motivated technician and then train them to get involved in learning to be a study coordinator. It is very satisfying to build a department and watch your staff grow into new roles.”
Clinical research can have many career benefits, but Fram said patient care should always be the focal point. Putting the work in to improve techniques and practices creates a trust with patients that is immeasurable, she said.
“They know that practices that are involved in research are constantly trying to improve outcomes and innovating,” she said. “It shows that your practice offers not just the standard of care, but the best possible care.”
Normal patient management and working within the confines of a clinical trial might not be exactly the same. Thompson said the overall goal remains but can often be tough to grasp at first.
“We become trained as physicians to care for a patient in a way that produces a desired outcome, either a cure or improving their situation,” he said. “A clinical investigator is treating a very specific patient population with a desired outcome that’s going to confirm the safety and efficacy of a new drug or device. Your hope is that the patient will benefit from the trial participation, but there’s just no guarantee. It’s a mindset that doctors need to prepare themselves for before they look at all of the other mechanics of getting involved.”
Although clinical trials can seem like the realm of seasoned veterans at the top of their field, there is plenty of room for younger researchers looking to get a start.
“We need to emphasize that trials are not just for the most established,” Venkateswaran said. “Young doctors can get involved if they partner with more senior doctors or find ways to collaborate on a small scale initially and then steadily build from there.”
- Reference:
- Institutional review board (IRBs) and protection of human subjects in clinical trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials. Published Sept. 11, 2019. Accessed Feb. 3, 2022.
- For more information:
- Nicole R. Fram, MD, can be reached at Advanced Vision Care, 2080 Century Park East, Suite 911, Los Angeles, CA 90067; email: drfram@avceye.com.
- Jodi I. Luchs, MD, can be reached at Florida Vision Institute, 1515 N. Flagler Drive, Suite 500, West Palm Beach, FL 33401; email: jluchs@aol.com.
- Vance M. Thompson, MD, can be reached at Vance Thompson Vision, 3101 W. 57th St., Sioux Falls, SD 57108; email: vance.thompson@vancethompsonvision.com.
- William B. Trattler, MD, can be reached at Center for Excellence in Eye Care, 8940 North Kendall Drive, Suite 400-E, Miami, FL 33176; email: wtrattler@gmail.com.
- Nandini Venkateswaran, MD, can be reached at Massachusetts Eye and Ear Waltham, 1601 Trapelo Road, Suite 184, Waltham, MA 02451; email: nandini.venkat89@gmail.com.
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