BLOG: Three truths about clinical research in medical practices – Healio

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Biography: Hovanesian is a faculty member at the UCLA Jules Stein Eye Institute and in private practice at Harvard Eye Associates in Laguna Hills, California.

Disclosures: Hovanesian reports no relevant financial disclosures.

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After more than 20 years participating in perhaps 50 clinical trials for early-, mid- and late-stage drugs and devices, my practice has learned a few lessons about clinical research and how it fits into a medical practice.

1. Operationally, it’s challenging. You need motivated, well-trained medical assistants who are part study coordinator and part salesperson, giving patients a positive experience while collecting and documenting the myriad data points to satisfy a sponsor. Companies sponsoring studies can’t help when you’re short staffed or unusually busy. Maybe you thought recruitment would start perfectly in February, your slow season, but FDA delays held it off until July, when you like and need to take time off. Small drug and device companies have funding for only so long; when they say “go,” they need you to sprint toward recruitment. And when the FDA drops in for an audit in military-style uniform, you need to drop everything for as long as it wants to ask questions. Sometimes that’s 2 weeks.

John A. Hovanesian

2. You won’t get rich. While study reimbursement is additive to your existing clinical revenue, the extra personnel, office and storage space, use of supplies, weekend meetings, and the hundreds and hundreds of forms and signatures all occupy a big part of your bandwidth and generate real costs. Mostly, research is a labor of love.

3. It’s highly rewarding. It’s fun to use a device that most of your colleagues have never heard of and exciting to give talks about it at meetings. Everyone in and outside your practice recognizes the importance of breaking new ground. Patients understand you must be very up to date if you are offering research. Staff members take pride working in a place that is expanding science. Your name on publications boosts your credibility, and it gives you a fresh perspective on your specialty. For me, these make it all worthwhile.

It’s easiest and maybe most profitable for any business or practice to maintain the status quo of its current high-margin offerings. But if your goal is to reach higher, testing your abilities and growing your staff’s knowledge, you will find clinical research an extremely rewarding and worthwhile pursuit.

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