BLOG: Three questions for would-be clinical trial centers
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As the cover story in this issue of Ocular Surgery News discusses, many physicians romanticize clinical research as an exciting way to deliver cutting-edge care to patients while realizing significant new revenues. Any experienced clinical trial center can tell you the truth is much less exciting. At my practice, Harvard Eye Associates, we have performed nearly a hundred clinical trials to date. It’s truly exciting to get to use new drugs and devices before other physicians have even heard of them. But while there are many benefits to performing clinical research in your practice, there are also significant challenges.
Here are three questions that are worth asking for any would-be clinical trial center:
1. Do I like my free time? In between patients, when you are not finishing up charts, answering phone calls and working out staff problems, how interested are you in signing off on piles of clinical study-related paperwork, meeting with trial monitors or combing through a study budget to determine if you can accept it? On weekends, do you like to catch up on Netflix, or would you rather spend time at an investigator meeting in an airport hotel conference room in a U.S. central city like Dallas or Chicago? These are all the glamorous types of activities that you will take part in if you embark on clinical trials. They are time-consuming and additive to the work you are already doing in your practice. They become significantly more onerous when an auditor from the FDA shows up in a military-looking uniform to pore through charts, spending days with you and your staff to determine where you might have made a mistake.
2. Do I like selling? Normally when a drug or device company representative walks through your door, you are the customer — the one deciding how much time you will spend with the representative. The tables turn when you are a research center. The drug/device company sponsoring the trial becomes the customer, and you become the seller of your services, trying to differentiate yours from those of competing practices that also seek to do clinical trials. Emails and phone calls must be answered promptly, and representatives must be welcome to spend as much time with you and your staff as they need. With your patients, you are also “selling,” trying to help them understand the benefits of participating in a trial and explaining complex concepts like a placebo-controlled trial and why the patient would want to take a chance on one. Some trials are easier than others to recruit, but all require special effort and a change in the color of your relationship with your patient. You are offering patients something that is hopefully better than the standard of care, and they are taking a chance on you and on the protocol in which they are enrolling. Either way, you are “selling,” and they are considering whether they want to “buy” into the study.
3. Is my practice ready? As our cover story discusses, you will need space, staff and patients to accommodate clinical studies. You need space for storing records, which are on reams and reams of paper in virtually all studies we have worked in. These sometimes require obtaining an outside storage facility at a cost that is not often included in the study budget. As for staff, it takes the right kind of personality and skill set for a staff member to double as a research coordinator. It is scarcely affordable for a practice starting out to dedicate a full-time person to this role. Finally, your practice must be ready with a high patient volume. Any study entails a great deal of work in the startup and closeout phases, regardless of the number of patients you enroll. Yet, payment to the practice is based almost exclusively on patient enrollment. The worst outcome is to recruit too few patients and waste dozens of uncompensated hours. Go into every study with a realistic idea of what your patient volume is and what percentage will qualify for the study, given its unique inclusion and exclusion criteria.
Despite all the cautions above, clinical trials can be an incredibly exciting part of your practice that reinvigorates your interest in practicing medicine and helps your staff feel excited about the uniqueness of what you offer. It deepens your relationship with and respect for industry partners and fellow research sites across the country. It gives opportunities for speaking at meetings and writing articles — like this one. If you decide to engage in research, I can promise that you will fall way behind on social media and sports scores. If your priorities are right, though, it’s well worth the effort.
Disclosure: Hovanesian reports no relevant financial disclosures.