The Lowdown on Clinical Trials

With the past breakthrough development of COVID-19 vaccines and novel potential treatments, clinical trials have never been more top of mind among the general public. In eye care, research barely experienced a slowdown during the pandemic. Ocular surface disease, now and for the foreseeable future, will be a particularly active area.¹

Research also becomes relevant when we consider the baby boomer population, which is at higher risk for dry eye and age-related conditions. Clinically, there is a large push toward developing ways to detect changes associated with macular degeneration earlier in the disease for more successful interventions. As optometrists, we are on the forefront of primary eye care, and innovative new treatments in these areas will greatly affect our patients. Getting involved in clinical research can provide an inside look at the therapeutic pipeline, while enabling us to gain experience with a novel treatment. But it may not be a great fit for everyone. You’ll want to give serious consideration to the points addressed below before you apply to participate as an investigator in a study.

HOW CLINICAL STUDY INVOLVEMENT CAN BENEFIT A PRACTICE

Aside from providing an inside look at treatments and technologies that are in development, being a part of clinical trials can also provide cutting-edge therapeutic options to patients, giving them access to treatments they otherwise would not have had. This can improve their outcomes at no cost to them and increase their satisfaction with their care.

Offering research trials also serves as a marketing tool that sets your practice apart from others. You will notice an influx of new patients who may not have come to your practice if not for the research opportunity, and many may become established patients.

Being a clinical trial site provides an additional revenue stream separate from the day-to-day practice, potentially increasing profitability. As an investigator, you are paid through an outside sponsor or contract research organization (CRO), which usually offers a per patient reimbursement that works out to be a higher monetary return per patient encounter than can be obtained through third-party insurance reimbursement. Some large practices are known to bring in 30% to 40% of their annual revenue through clinical trials.

Of course, there are other financial considerations.

INCOMING AND OUTGOING EXPENSES

Your net financial gain will be the total reimbursement/compensation you contractually agreed to receive for completing the study, minus the expenses incurred from conducting the study. The total fee paid to you will vary, depending on the study and the sponsor. The fee may be a set amount for each patient encounter or a total amount for the number of completed patients.

Expenses may or may not include:

• Overhead.
• Rent. This is generally not a factor, as you are paying rent regardless of whether you participate in clinical trials or not.
• Support staff. This is not necessarily a factor if you run trials during normal operating hours. You may already be paying the staff for seeing patients. If you run trials on weekends and your practice is not usually open on weekends, then you would calculate the extra hours you need to pay your staff.
• Reimbursement for your time or additional doctors' time. As the investigator, you may choose to perform all of the visit yourself, or you might choose to delegate some of the responsibilities to subinvestigators.

Specific study-related costs include:

• Compensation to both completed and discontinued patients. This is typically a set amount and is stipulated by the sponsor and informed consent.
• Supplies and additional equipment, if needed.
• Your time as an investigator for preparatory work and overall involvement.

ARE CLINICAL TRIALS A GOOD FIT FOR YOU?

When considering becoming a clinical investigation site, take the time to ask yourself the following questions.

• Do I have the physical space to properly participate (ie, enough examination lanes for efficient patient flow and a large enough waiting area to accommodate participating patients)?
• Do I have sufficient staff and technicians to handle the planned patient volume, and are they willing to perform some new duties?
• Do I have enough time in my schedule, and am I willing to work longer hours and/or weekends? If I don’t want to work longer hours, do I have the flexibility in my schedule to incorporate the clinical trial activities without adding significant hours, or do I have an associate who can help divide the additional workload?
• Do I have the proper technology and equipment needed to participate in the clinical trials in which I am interested?

Once you’ve answered these questions, identify the types of trials you want to get involved in and the treatments or technologies you want to study. Determine the size of the study and how many patients would need to enroll and complete to achieve clinically significant findings; then decide if your patient database is large enough or if you will need to recruit outside patients.

WHAT IS AVAILABLE?

There are different types of clinical research trials. Some are company-sponsored, investigator-sponsored, or sponsored by a non-profit or institution. To seek them out, you can search online databases; register with a site; network with colleagues; ask your drug or device reps; develop a relationship with a CRO, some of which specialize in ophthalmology; or ask the sponsor of an ongoing study if they need investigators.

Working with a skilled CRO makes all the difference for a successful and smoothly run trial. A company will come into a practice to facilitate the trial, allowing the doctor to focus on the clinical care of the patients.

A REWARDING ENDEAVOR

In determining whether participating in clinical research is right for you and your practice, consider the time factors discussed above. Other considerations may include the number of investigators required and any specific hurdles with regard to your location or community.

If you’ve weighed all the options and decided that becoming involved in a clinical trial makes sense for you, you’ll find that offering trials is a meaningful way to contribute to the field of eye care.