Participating in Ophthalmology Clinical Trial studies can benefit your practice. You can earn additional income, get a new opportunity to promote your practice, and expand your own skills and those of your employees. But it is not for every practice. To reap the rewards, you have to put in your time, learn the ropes, and be careful of your pace in the beginning.
5 Steps to Start An Ophthalmology Clinical Trial
In our last post, we discussed why an ophthalmology practice might want to participate in clinical research studies and some caveats. Now we’re going to explain how to get your foot in the door.
Explore available trials
There are several different ways your practice can start participating in clinical research studies: they can be company-sponsored (drug or device companies), investigator-sponsored (ie, a doctor who wants to test a new application of an existing drug), or sponsored by a non-profit organization or institutions (such as a university or hospital).
If you’re just starting out, go for corporate or commercially sponsored Ophthalmology Clinical Trial, experts recommend. They usually have the most training opportunities, are the most receptive to questions, and have the most supervision—not to mention the test protocol is written for you.
There are many ways to search for clinical research studies, according to attorney Caroline Patterson, who spoke about clinical studies at the 2017 AAO Annual Meeting. You can:
- Search online databases
- Register with a site dating service or study broker
- Network with colleagues (conferences are especially good for this)
- Ask your drug/device representative
- Develop a relationship with a clinical research organization (some specializing in ophthalmology)
- Ask sponsors of ongoing studies if they are looking for sites for the next phase.
Next, determine which options might be a good fit for your practice and your interests. For example, many clinical research studies are double-blind and therefore require two doctors, says Joanne Mansour, practice manager at the Virginia Retina Center and another AAO 2017 presenter. That’s not ideal for solo practice.
Also read:- What Does Ophthalmology CRO Mean?
Contact the trial sponsor or CRO
They will vet you, assess your interest and you too. If you still want the opportunity and the sponsor decides that your practice is suitable, they will invite you to the next stage of site selection. At this point, you will complete a Ophthalmology Clinical Trial (OCT). You will also receive a study protocol summary for review and the sponsor will take a closer look at whether your site (including your staff, patient population, equipment, etc.) is a good fit. If you are selected, you will receive an award letter along with a full study protocol and budget. This is the point where you would negotiate terms if possible.
Recognize potential obstacles
You have to be savvy when negotiating. If you’re not, clinical research may cost you more than you thought. Sometimes there is no negotiation (for example, when the study is funded by a grant) and the sponsor’s terms are take it or leave it. If there is room for negotiation, keep these finer points in mind:
- What tasks are involved and what is the time value of these tasks?
- What, if any, might be your financial responsibility?
- Screening patients takes time, effort and money. Do you get any reimbursement if the patient ends up not qualifying?
- Will you receive compensation if the subject drops out during the court proceedings?
- What are the payment terms? Is payment per visit, item or one lump sum at the end? If you have to wait until you graduate to get paid, is it possible for your practice to pay all the costs of your studies up front?
- What about costs specific to your site? For example, in urban practice, parking can be expensive.
- What type of legal protection does the contract include (ie malpractice insurance)?
There is one caveat when it comes to negotiations. Study the trial contract carefully, but don’t be so painful that the sponsor chooses a different Ophthalmology Clinical Trials, cautions Mansour. Avoid heavy-handed demands or ultimatums. Word will eventually get around and it will be more difficult for you to secure attendance at the exams.
Do your due diligence
Do this before you sign up and make sure you know any out-of-pocket expenses you may incur. That’s especially important in a grant-funded study, Patterson notes, when the funding often doesn’t cover the full cost of the trial. He recommends comparing tuition fees with Medicare reimbursement rates to get some perspective. A generous payout can turn out to be not so great once you crunch the numbers.
Study sponsor: the group (usually a commercial or pharmaceutical company) that commissions and pays for the study.
Clinical Research Organization (CRO): A group that sometimes hires sponsors to conduct a study. This is the MAC version for the research world. Among other things, the CRO identifies and recruits participating physicians and sites, monitors study progress, and manages finances.
Site Management Organizations (SMOs): CROs sometimes outsource the recruitment of physician and study sites to SMOs.
Clinical Research Manager: If you get deep into clinical research, you may end up adding this position to your staff. This person reviews study protocols, negotiates, liaises between you and the study sponsor, and ensures that you are following good clinical practice guidelines and FDA rules.
Institutional Review Board (IRB): According to the FDA, an IRB is “a group that has been formally designated to review and monitor biomedical research involving human subjects.” Clinical research studies must be submitted to an IRB for review—the IRB can approve the study as is, require modifications, or disapprove. You must also ask the IRB to approve any study advertising or marketing (used to locate participants).
That’s you. The investigators are responsible for data collection during the study. The principal investigator is usually a physician and is ultimately responsible for the integrity of the study data. Other investigators at the same study site are co-investigators.
This is a great position for the perfectionist in your practice. This person should be detail oriented and meticulous. In addition to hands-on patient care, this person performs administrative tasks such as record keeping. You can hire someone with experience in clinical trials, but if you’re just starting out, you can spend some of the technical time on it, notes Mansour.
CROs often use internal study monitors – they visit the study sites and verify that you are conducting all aspects of the study according to the protocol. This takes place throughout the course of the study. Auditors perform similar duties, but are third-party people hired by the study sponsor. Auditors provide broader oversight and assess whether monitoring studies are operating effectively.
Notice something missing from this list?
Don’t forget your lawyer! An attorney experienced in clinical research trials can review agreements for legal implications, including issues of liability, insurance coverage, HIPPA and other confidentiality regulations, and proprietary/publication rights. It can also ensure you stay within the limits of the Civil Monetary Penalties Act (CMPL), the Sunshine ACT and offer advice on potential financial conflicts of interest.
Contact The Clinical Trials Team
Starting Ophthalmology Clinical Trials research trials requires a team of people both inside and outside of your practice. They all work together to ensure the proper conduct of the clinical trial and the credibility of the final results. Reach out to Vial to conduct ophthalmology clinical trials.