Running a Clinical Trial: Risks vs. Rewards

Clinical Trials

Are you tired of tangling with payers over every last dollar? The good news is that your practice can take advantage of payer-free revenue streams to help you reduce your reliance on ever-more powerful payers. For some ophthalmologists, this means turning to retail optical. For others it means adding cosmetic services to their menu. In your case, it might mean looking beyond traditional patient care and running clinical trials in your practice.

“Some of these studies, I’m just amazed at how generous [sponsors] can be,” says Joanne Mansour, practice manager at The Virginia Retina Center, and who gave ophthalmologists a crash course in clinical research trials at AAO 2017.

Clinical trials can put your practice on the right track for new revenue streams and increased profit—but they’re not exactly a simple sprint. They’re more like a longer race that requires plenty of training and pacing. Read on to learn what it takes for your practice to develop a winning clinical trials strategy.

How Clinical Trials Can Boost Your Practice

In addition to helping you grow your revenue stream in a time of revenue shrinkage, participating in clinical trials has other benefits for your practice and your patients. Clinical trials …

  • Give patients a positive outlook. You’re giving them the opportunity to try a treatment that they would not receive otherwise.
  • Can improve patient outcomes.
  • Remove cost as a factor in whether or not a patient continues treatment, adheres to medication, or keeps their follow-up appointments.
  • Increase patient satisfaction. You’re following the patients’ progress very closely and have the additional resources available to do it, so they are getting extra, personalized attention.
  • Attract referrals from other physicians.
  • Are a marketing tool. They show that your practice is on the cutting edge of technology and they frame you as a leader in your specialty.
  • Are an excellent development opportunity for staff.
  • Can help your practice build its patient base. Once the trial ends, patients may be more likely to stay with your practice.

Responsibilities—and Risks

The positives are plentiful, but they’re certainly not the only things you should focus on. Conducting clinical trials is a balancing act in your practice, so you need to plan carefully, says Mansour. “Practices that don’t do [trials] don’t know where to begin,” she says.

Consider Your Physical Setup

You’ll need extra space for special equipment like centrifuges, refrigerators or freezers, and other devices, and also for extra administrative work and file storage. And don’t forget: you’ll need to make accommodations for your everyday practice, too. For example, attorney Caroline Patterson, who also discussed clinical trials at AAO 2017, recommends a dedicated exam lane. That means one lane fewer for regular patients, and that will probably affect your scheduling and patient flow.

Tip: Late-phase studies are usually less disruptive to your usual flow, notes Patterson. Those don’t require imaging, PK (blood) samples, or many follow-ups. Some practices also have a dedicated “study day” during which they see only study patients.

A truly research-based practice will usually designate separate staff and facilities for research endeavors. If you’re just dipping your toe in, that’s not necessary.

Staffing for Clinical Trials

A staff that is inexperienced in running clinical trials is going to need a significant ramp-up period. And your staff must be willing to learn in the first place. Not everyone relishes extra training and performing new duties they may be uncomfortable with. Don’t minimize the work involved, warns Mansour. When staff is training for—and working on—the trial, who will care for your regular patients? Whoever you appoint as your study coordinator will spend considerable time recruiting, screening, and enrolling patients. You’ll need to figure out how those tasks will fit in with his or her normal job duties.

You’ll also need ancillary staff like a certified refractionist, BCVA techs, certified photographers and techs for diagnostic testing, Mansour adds. See a pattern? Pretty much everyone who works on the study needs to be certified for whatever they’re doing.

Ready to jump in? In our next post, our experts will explain exactly how to get started in clincal trials. 

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