Clinical trials: What to keep in mind

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In the spring 2024 issue of Modern Retina you will read an enlightening account from Pamela Ann Weber, MD, about her experience conducting clinical trials. If you are not already involved in such trials, perhaps she will inspire you to look into doing so.

Having started enrolling patients in clinical trials 37 years ago, I can’t resist offering my own thoughts:

• It’s fun! We ophthalmologists love innovation, and being among the first to try out new and hopefully better drugs and devices is nothing short of fascinating and a great learning opportunity.
• Patients (and most of your ophthalmologist colleagues) respect those they view as being on the cutting edge. I say most, because when I started doing excimer laser trials in the 1980s, a number of my senior colleagues told me I was “insane” to risk operating on an eye that could see with glasses. You will probably encounter similar skepticism from time to time.
• When you offer the option of participating in a trial, you will see that many patients are very altruistic. I have rarely heard, “I am not a guinea pig!” More often, I hear, “If this might help other people with my disease, I would like to participate in the study.”
• When the data are unmasked and analyzed and new treatments are available, your experience allows you to be a resource for your fellow ophthalmologists in your area, advising them on how best to incorporate the new technology into their practices.

At the same time, conducting clinical trials is serious business. Any new drug or device might have unforeseen adverse consequences for your patients, so careful attention to inclusion and exclusion criteria and informed consent is a must. Even if you do everything perfectly, a patient might experience a bad outcome (eg, severe inflammation and occlusive retinal vasculitis after injection of a new biological), and you may feel bad because you care about your patients.

Careful adherence to the study protocol and diligent record keeping are vital—there is a reasonable likelihood that your charts will be audited. Lastly, you must do what you say you will do. If you don’t devote the time and effort required, people in the industry will not trust you and you will not be invited to participate in future trials.

Peter J. McDonnell, MD

McDonnell is director of the Wilmer Eye Institute, Johns Hopkins University School of Medicine, in Baltimore, Maryland, and chief medical editor of Ophthalmology Times®.

P: 443-287-1511
f: 443-287-1514
E: pmcdonn1@jhmi.edu