contact lens practice pearls
Become a Clinical Investigator
BY THOMAS G. QUINN, OD, MS, FAAO
Being a clinical investigator for a manufacturer of eye-related products is rewarding in many ways. It provides the unique opportunity to work with new products before they come to market, or to evaluate current products in a new way. It impresses patients from the perspective of, “If he's an investigator, he must know what he's doing.” Additionally, you are providing a great service to the sponsoring manufacturer. By exposing the company's product to a wider array of individuals, your findings provide valuable information regarding product safety and efficacy as well as subjective acceptance. Also, you do receive payment for your services. Intrigued? Here's what it takes.
You Need to Want It
With all the benefits that come with being a clinical investigator, don't do it unless you're interested in research. If you aren't interested in the study, the extra time and schedule demands will be a drain rather than a delight.
Attractive candidates include those who have distinguished themselves in their profession through publications, participation in a contact lens residency program, and participation in other clinical studies.
You must be discreet. It's imperative that you share information only with the parties directly involved. If someone doesn't need to know, don't tell him. This includes the sales representatives for companies you may be assisting as an investigator.
Have a staff member serve as your in-office coordinator. There are too many phone calls, e-mails, and other details for you to manage alone. Sponsors expect forms to be completed in a timely fashion and delivered on schedule.
Everyone involved in clinical studies must have training in Good Clinical Practice. The National Institute of Health (NIH), as well as other organizations, offer training that ensures you are aware of proper treatment of subjects who volunteer in a clinical investigation. If you haven't done this training, I recommend that you and your in-office coordinator do it now. It will increase your attractiveness as a potential study site. It's offered on-line and takes a few hours to complete. You can find the NIH course at http://phrp.nihtraining.com.
A large practice has a greater pool of patients from which to select, but sometimes patient demographics are more important than patient numbers. For example, if embarking on a lens solution study, do you have patients in the materials that the manufacturer wishes to test? My point is: size matters, but don't be discouraged if your practice isn't huge. You may have the right mix!
You must keep all study products locked in a secure location and dedicate an area of the office to this purpose. It's important to have an office layout that allows the informed consent process to take place privately. As the Good Clinical Practice Training points out, there can be no attempts to coerce patients into participating. You must provide a pressure-free environment where they can choose whether to participate in the study. Obviously, you must keep all information confidential. Aso note that all studies involving humans must be approved by an IRB/ethics board.
Some studies require special equipment, but most employ what most of us already have in our office. If unusual equipment is needed, often the sponsoring company will supply it.
How Do I Start?
Once you've created a mindset, office team, and physical plant that makes the grade, call your favorite sponsoring manufacturer and express interest in serving as a clinical investigator. They'll put you in touch with the right person. It's worth investigating! CLS
Special thanks to the numerous manufacturer study monitors who assisted in preparing this column.
Dr. Quinn is in group practice in Athens, Ohio. He is a diplomate of the Cornea and Contact Lens Section of the American Academy of Optometry, an advisor to the GP Lens Institute and an area manager for Vision Source. He has served as an advisor or consultant to Coopervision, CIBA Vision and Vistakon and has received research funding from AMO, B&L, CIBA Vision, Coopervision, and Vistakon.