Participating in clinical research trials can be a boon to your practice. You may receive additional income, gain a new opportunity to promote your practice, and grow your own and your staff’s skill set. But it’s not for every practice. In order to reap the rewards, you must take your time, learn the ropes, and be sure to pace yourself in the beginning.
Clinical Trials: 5 Steps to Getting Started
In our last post, we talked about why an ophthalmology practice might want to participate in clinical research trials, and about some of the caveats. Now, we’ll explain how to get your foot in the door.
Step 1: Research Available Trials
There are a number of different ways your practice can initiate participating in clinical research trials: they can be company-sponsored (by drug or device companies), investigator-sponsored (i.e. physican who wants to trial a new application of an existing drug), or sponsored by a non-profit or institution (like a university or hospital).
If you’re just starting out, go with company or commercially-sponsored trials, experts recommend. They typically have the most training opportunities, are the most receptive to questions, and have the greatest degree of oversight—not to mention, the trial protocol is spelled out for you.
Step 2. Identify Opportunities
There are many ways to seek out clinical research trials, according to attorney Caroline Patterson, who spoke about clinical trials at the AAO 2017 annual meeting. You can:
- search online databases
- register with a site-listing service or study broker
- network with colleagues (conferences are especially good for this)
- ask your drug/device reps
- develop a relationship with a clinical research organization (some of which specialize in ophthalmology)
- ask sponsors of in-process studies if they are looking for sites for the next phase.
Next, determine which options might be a good match for your practice and your interests. For example, many clinical research trials are double-blind and thus require two physicians, says Joanne Mansour, practice manager at The Virginia Retina Center, and another AAO 2017 presenter. That’s not ideal for a solo practice.
Step 3: Contact the Trial Sponsor or CRO
They’ll vet you, gauging your interest, and you’ll vet them as well. If you still want the opportunity, and the sponsor decides your practice is a good match, they will invite you to the next phase of site selection. At this point, you’ll complete a confidential disclosure agreement (CDA). You’ll also receive a synopsis of the study protocol to review, and the sponsor will take a deeper look at whether or not your site (including your staff, patient population, equipment, etc.) is a good fit. If they choose you, you’ll receive an award letter along with the full study protocol and budget. This is the point where you’d negotiate terms, if that is an option.
Step 4: Know the Potential Hurdles
You need to be savvy about negotiations. If you’re not, a clinical research trial can end up costing you more than you thought. Sometimes there’s no negotiation (for example, when the study is grant funded) and the sponsor’s terms are take-it-or-leave-it. If there is room to negotiate, keep these finer points in mind:
- What tasks are included and what is the time value of those tasks?
- What, if anything, might be your financial responsibility?
- Screening patients takes time, effort, and money. Do you receive any compensation if a patient ultimately doesn’t qualify?
- Will you receive compensation of if a subject drops out mid-trial?
- What are the payment terms? Is payment per visit, per subject, or one lump sum at the end? If you must wait till the study is completed to get paid, is it feasible for your practice to pay for all the study costs up-front?
- What about costs specific to your site? For example, in an urban practice, parking may be expensive.
- What type of legal protection does the agreement include (i.e. malpractice insurance)?
When it comes to negotiating, there is one caveat. Carefully review the trial agreement, but don’t be such a pain that that the sponsor decides to go with another practice, warns Mansour. Avoid heavy-handed demands or ultimatums. Word will eventually get around, and it will be more difficult for you to secure participation in trials.
Step 5: Conduct Your Due Diligence
Do this before signing on, and be sure you know every out-of-pocket cost you may incur. This is especially important in a grant-funded study, Patterson notes, when the funding often will not cover the entire cost of the trial. She recommends comparing study fees to Medicare reimbursement rates to gain some perspective. A generous payment might turn out to be not all that great once you’ve run the numbers.
The Clinical Trials Team
Getting started in clinical research trials requires a team of people, both inside and outside your practice. They all work together to ensure the clinical trial is carried out properly and the final results are credible. This isn’t a complete list, but here’s a who’s who:
Study Sponsor: the group (usually a business or drug company) that commissions and pays for the study.
Clinical Research Organization (CRO): A group that sponsors sometimes hire to implement a study. This is the research world’s version of a MAC. Among other things, the CRO identifies and hires participating physicians and sites, monitors the study’s progress and manages the finances.
Site Management Organization (SMO): CROs sometimes outsource the recruitment of physicians 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 assesses study protocols, negotiates, is a liaison between you and the study sponsor, and ensures you’re 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 trials must be submitted to an IRB for review—the IRB can approve the study as-is, require modifications, or disapprove. You must also get the IRB to approve any study advertisements or marketing (used to find participants).
Investigator: This is you. Investigators are responsible for data collection during a trial. The Principal Investigator is usually a physician and ultimately responsible for the study’s data integrity. Other investigators at the same trial site are co-investigators.
Study Coordinator: 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 like record keeping. You could hire someone with clinical trial experience, but if you’re just starting out, you can allocate part of tech’s time to this, notes Mansour.
Study Monitor/Auditor: CROs often use internal study monitors –they visit study sites and verify that you are conducting all aspects of the study according to protocol. This is ongoing throughout the study. Auditors perform similar duties, but are third-party folks whom the study sponsor hires. Auditors provide broader oversight, and assess whether study monitors are performing effectively.
Conduct your own quality assurance (QA), Patterson recommends. Review regulatory files and patient charts randomly each quarter. This will help you prepare for an audit, educate your staff, and further refine you data collection procedures.
Notice anything missing from this list? Don’t forget your attorney! An attorney with experience in clinical research trials can review agreements for legal implications including liability issues, insurance coverage, HIPPA and other confidentiality regulations, and proprietary/publication rights. He or she can also ensure you stay with the boundaries of the Civil Monetary Penalties Law (CMPL), the Sunshine ACT, and offer guidance on potential financial conflicts of interest.