By Brian Chou, OD, 
FAAO
Taking part in clinical trials puts you on the leading edge. You gain access to the latest technology and medical devices while elevating your image in the eyes of patients. There may be financial rewards, as well.
BENEFITS TO
CLINICAL TRIALS
- Access to the most advanced optometry including new products such as newly developed contact lenses and new medications.
- Association with cutting edge research resulting in enhanced practice image.
- Opportunity to enhance skills and expand your practice by attracting new patients interested in participating in the trials.
Greater patient loyalty as patients see that there is no need to look elsewhere. You already offer them the latest and greatest treatments and products, so why go anywhere else?
Manufacturers of contact lenses, lens solution, pharmaceuticals, ophthalmic instruments and spectacle lenses administer clinical studies for product development, FDA clearance and marketing. Optometric practices are frequently invited to administer these studies. While some of the studies can be done in-house by the manufacturer, others must be done in real-life practices since that’s where the products will be put to use. Participating in such studies gives patients the opportunity to experience the latest treatments and gives you the opportunity to engage patients and enhance your practice brand.
Business Opportunity Beyond Generating Revenue
From a business perspective, the revenue generated from administrating a clinical study is usually on-par with a poorly reimbursing vision plan,but some study sponsors pay generously and compensation is sometimes negotiable. When payment is sub-par, administrating a study is still financially beneficial to the extent that you’ve got unfilled appointment slots. This is analogous to a hotel accepting reduced room-rates to fill up rooms that would otherwise go un-booked. However, in these cases take care not to schedule clinical study patients during prime appointment times, such as weekday evening or weekend appointments. Otherwise, you can displace revenue from your regular patient visits.
There are other advantages to administering clinical studies. From a marketing angle, it can elevate the stature of the practice, make patients aware that the practice has access to new technology, and increase patient loyalty to the practice. Subjects will often tell their family, friends and co-workers that they’re participating in a study at your practice, which can lead to word-of-mouth referrals. Collateral new patients generate derivative revenue unrelated to the study. Study subjects often like participating in studies, especially if they have unmet needs that existing product cannot fulfill. Additionally, subjects typically receive compensation for their participation. A word of caution–I discourage sponsors from offering free products such as contact lens supplies and eyeglasses because that can undermine your practice’s ability to sell product. Most of the established study sponsors know this, but some of the start-ups do not. It’s much better if compensation to subjects is in the form of money or a gift card to a restaurant. Finally, administering a clinical study for a product that has not yet been commercially launched gives you an inside track for becoming the local expert. It can also be a nice change of pace from your normal practice routine.
Solicit Invitation from Manufacturer
Participation requires an invitation from one of the manufacturers. There typically are no direct fixed costs for participation, since most optometric practices are already paying for their facility, licenses and existing instrumentation. The cost of participation becomes the amount of doctor time and staff time to manage the administrative aspects of participation.
Try reaching out to manufacturers based on your practice’s specialties. If you have a strong contact lens practice and do a significant amount of business with a particular contact lens company, let the sales rep know you’d be interested in participating in one of their future clinical evaluations. They may throw you a small bone for a non-essential marketing study. If you collect data accurately and in a timely fashion, that may invite you to future studies which can lead to bigger and better opportunities. However if you fail in recruiting the number of required subjects or do not turn in the required case report forms, don’t count on being asked again.
I’ve been involved in over 40 clinical studies, mostly with contact lenses, ophthalmic instruments, and spectacle lenses. Right now, I am administering one for a start-up manufacturer that has a portable self-administered refractor intended for the Third World.
Simple OD Requirements
The simple requirements to participate in clinical studies include proof of licensure and professional liability and a signed investigator agreement with non-disclosure.
Manufacturers are looking for practitioners with their ideal patient demographic and practice setting. For example, a pharmaceutical company that has a new glaucoma drug will pass up my practice because my patient demographic is young with few glaucoma patients. For the manufacturer, it is important for their study sites to have an adequate patient base. With deadlines to meet, the manufacturer cannot dilly dally with practitioners who struggle to enroll subjects. Given a choice, they will choose a practice with a solid track history of administering clinical studies and completing them quickly and accurately. They want minimal headache. A practice with the computerized infrastructure to search for patients meeting enrollment criteria is also a huge plus. For example, contact lens manufacturers with a new keratoconus design like my practice because I have a relatively large keratoconus practice and my practice uses electronic medical records.
Get Informed Consent and Maintain Confidentiality
During a clinical study, you should still do what a reasonably prudent practitioner would to meet or exceed the standard of care. Also, make sure the patient undergoes proper informed consent to participate. It is important that practitioners abide by any non-disclosure agreements required by the study sponsor. I’ve heard some doctors proudly say at meetings in front of their peers that they were a clinical study investigator for Company X’s contact lens, and that the lens evaluated was “bad.” This makes me cringe, because it is a violation of any signed non-disclosure to administer the study. Aside from being a breach of contract, as a matter of principle, it is unethical for a practitioner to convey confidential and privileged information to another party without the sponsor’s permission.
Cost in Time
The sponsor may require training on how to administrate the study.For example, if the evaluation is for a new contact lens, the doctor may have to undergo web-based training on the prescribing protocol.This may take anywhere from 30 minutes to several hours.
Practitioners who administer clinical studies need to realize that they are not really scientists, but worker bees being told what data to collect by the sponsor. Data collection is often dull and tedious, and the administrative burden can be worse than what’s involved with third-party billing.For example, I was an investigator for the SynergEyes KC lens for keratoconus in 2003 which had lots of documentation requirements which I do not miss. There are clinical studies that require the doctor to record measurements that are not important for offering optimal care for the patient but they are required by the study sponsor for their own data analysis. There have been instances where I’ve gotten back data clarification requests simply for making an accidental pen mark close to a data entry field. This sort of stuff is burdensome, especially if the doctor does not have a staff member making sure all the spaces are filled out, signatures collected, forms faxed back for each visit, etc.
As I’ve gotten busier, I increasingly delegate administrative aspects of studies to ancillary staff. You can also have an associate perform the clinical measurements under your supervision.The best sponsors will offer assistance in reducing the administrative burden by paying for patient recruitment or dangling incentives for one of your employees to complete paperwork.
Clinical Studies:Have thePatient-DoctorConversation
Doctor:“Mrs. Jones, I have anopportunity which I wanted to run by you.My office is enrolling 20 patients in a clinical study for a new contact lens for keratoconus.”
Patient:”Oh, I don’t know. I don’t like to participate in that kind of stuff.”
Doctor: “Thismay be a good opportunity for you to access a treatment I would not otherwise be able to provide you with.”
Patient: “Really?How does it work? Is it expensive and do I have to do anything?”
Doctor:”You are eligible to participate because you meet the enrollment criteria.The sponsor is paying for all the required visits.Although you are not allowed to keep the contact lenses, you receive $300 upon successful completion of the three required visits.You’d also be first in line to receive this lens once it becomes commercially available if you do well with the lens.Does this sound like something you’d consider?”
Patient: “Alright,I guess I’ll give it a try.”
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Brian Chou, OD, FAAO, is a partner with EyeLux Optometry in San Diego, Calif. To contact him: chou@refractivesource.com.
