What common mistakes might a practice owner make when starting to host clinical trials?
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Click here to read the Cover Story, "Clinical trial participation keeps surgeons on cutting edge of technology."
Unforeseen costs
Participating in clinical trials is an incredibly satisfying way to expand your fund of knowledge, experience and suite of services to offer your wonderful patients. So many of our patients still have unmet needs despite our current approved offerings. Participating in clinical trials is a brilliant way to bring cutting-edge approaches to your deserving patients.
We have learned a tremendous amount in our experience participating in clinical trials. There are surprising hidden costs for the practice that need to be taken into account. If you have a keen administrator and growth mindset-oriented staff, this can be easily overcome to create a greater whole.
A critical place to not cut corners on participating in clinical trials is in your clinical trials coordinator. This person is salaried higher and needs to be extraordinarily organized as well as driven to help patients. There is a surprising amount of back office logistics and coordination that needs to happen. With this in mind, your clinical trials coordinator may need assistance from the front desk and scheduling team.
Even though the learning curve has been steep, we have immensely enjoyed our clinical trial experiences. My staff see it as an exciting opportunity to learn more and contribute in an important way to our patients. Now that we have been exposed to the special opportunities of clinical trials, we are keen to add on several more additional studies.
Some of the other benefits of participating in clinical trials we have discovered include enhanced referral relationships, speaking and writing opportunities as well as the luxury of more time with our patients, which has enhanced our patient relationships in a wonderful way as well.
Even though clinical trials are stringent in data collection processes and recordings, there is also a lovely freedom that comes along with that. We are embracing and very much enjoying the standardization within the various protocols. When there is more standardization within the encounter, we have found our ability to make subtle observations actually increases.
Laura M. Periman, MD, is a Healio/OSN Board Member. Disclosure: Periman reports no relevant financial disclosures.
Mistakes are common
Mistakes are not uncommon for physicians new to clinical trials. While the experience is rewarding, the practice and the principal investigators need to follow certain guidelines to ensure success within clinical studies.
First, physicians need to assess whether they have adequate patient volume and pathology to meet enrollment numbers by study-specified deadlines. If a practice’s patient pool is not deep enough, enrolling appropriate patients for a trial may be difficult.
It is critically important to assign a dedicated, experienced staff member to serve as a clinical studies coordinator. This person will need additional training in order to handle the required paperwork with accuracy and in a timely manner. Additionally, practices should make sure that staff is allotted adequate time to complete the clinical trial requirements, from contacting patients to scheduling patients for the trials, meeting with monitors and submitting the collected data. A clinical studies coordinator can oversee all of these efforts.
All providers within the practice should be involved in the clinical trial process. Keeping providers engaged can make the process of finding potential candidates to enroll much easier. Having a physician champion, one who is enthusiastic about clinical research, spearheading the trials is key. Studies require time and dedication from everyone in the practice, especially from the principal investigator, the subinvestigators and the clinical study coordinator.
One final pearl is for all practices to review the proposed contract from the sponsor and negotiate appropriately.
Cynthia A. Matossian, MD, FACS, is an OSN Cornea/External Disease Board Member. Disclosure: Matossian reports no relevant financial disclosures.
Invest in a clinical research coordinator
As a private practice ophthalmologist who has conducted more than 25 clinical trials, there are several common mistakes that may discourage clinicians from participating in further studies.
It is wise to fully understand the role of an investigator, including adhering to proper protocols, reporting adverse reactions and following the regulatory requirements, all of which are vital to running a successful study. Physicians can often overestimate the number of patients they can enroll in a particular clinical trial. I have learned from experience that it is easier to underpromise and overdeliver.
It is of utmost importance that your clinical staff is properly educated and trained on what their specific responsibilities will be. First-time clinical investigators more than often recruit their existing staff to “wear a second hat” as research staff. The additional work, over and beyond their routine responsibilities, is time-consuming and stressful, which can ultimately affect accuracy and outcomes. After conducting several of my initial clinical trials, I found it necessary to hire a dedicated clinical research coordinator. Having a committed and educated staff can make all the difference for a successful clinical research site. Their responsibilities to manage institutional review board submissions, research budgets, subject visits and data collection while adhering to strict protocols have made a tremendous difference in my continued participation and success as a primary investigator. I found it worth the time and effort to have a devoted, trained research coordinator who is enthusiastic and accountable in this position.
Participation in clinical trials has allowed me to remain at the cutting edge of my specialty. I have found it rewarding to be able to influence innovation to ultimately improve patient care.
Alice T. Epitropoulos, MD, FACS, is a Healio/OSN Board Member. Disclosure: Epitropoulos reports no relevant financial disclosures.
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