Should You Participate in Clinical Research?

With so many novel therapeutic options for the back of the eye currently in clinical trials, it is no surprise that there is a call for qualified retina specialists to sign on as investigators for these trials. Participation in clinical research can be fulfilling for the investigator as well as his or her staff and practice. However, the decision to get involved should come only after careful consideration, research, and planning.

WHY PARTICIPATE IN CLINICAL RESEARCH?

Why did you become a retina specialist? Likely, your career choice was driven by a desire to learn more about the back of the eye and to improve the quality of life of those experiencing debilitating retinal diseases. Participating in clinical research provides an opportunity to take a bigger stake in medicine and find cures for seemingly incurable diseases.

Participation in clinical trials provides access to the latest and greatest developments in retina, putting those who are involved at the forefront of the newest trends and offering their practices the opportunity to use new drugs, devices, and technologies before they are available on the market. Katz S, Dufficy H, John C. Keys to success with clinical trials. Gastroenterol Hepatol (N. Y.). 2011;7(2):100-105. , Lader EW, Cannon CP, Ohman EM, et al. The clinician as investigator: participating in clinical trials in the practice setting: Appendix 2: statistical concepts in study design and analysis. Circulation. 2004;109(21):e305-307. Access to novel therapies and treatment strategies can have a positive impact on the reputation of a clinical practice and may even increase overall practice volume. Access to these treatment options is also beneficial for the practice’s patients. Because of the highly regulated nature of retina trials, study participants receive extra care and attention during close follow-up to ensure that their responses to the experimental treatment are documented and the treatment is safe. A typical patient may visit the practice once a year for an annual checkup, whereas study subjects visit frequently for treatments, monitoring, and/or testing, depending on the study design. Enrolled patients may benefit from new treatment options, diagnostic techniques, or technology in a controlled environment, often at no additional cost. This is especially beneficial for patients who have not responded to available treatments, as they may find success with an investigational therapy.

Advances in medicine today are largely evidence-based. Those who participate in these trials are granted access to evidence-based treatments and therapies, and because clinical trial results are often distilled into published reports, contributing principal investigators (PIs) may be asked to become coauthors of articles submitted for publication, a distinction for any clinician.2

WHAT IT MEANS TO BE A PRINCIPAL INVESTIGATOR

In addition to regular practice duties, a PI must also attend study-specific training, supervise the trial, interact with the institutional review board, manage study staff, develop and follow budgets, and manage audits and inspections, among other clinical study duties. Although a PI will certainly delegate responsibility to trained research staff, responsibility for the study’s initiation, progress, accuracy, quality, integrity, and completion ultimately rests with PIs. For retina specialists new to clinical research, becoming a subinvestigator and learning from an experienced PI is often suggested before taking on the PI role.

For anyone involved in clinical research, but particularly new PIs, it is often beneficial to complete online or classroom-based introductory courses on the principles and practices of clinical research. Supplementary courses might target the ethical and regulatory aspects of dealing with human subjects. Because observance of good clinical practice (GCP) is essential when conducting clinical research, it is generally recommended that PIs, along with their study staff, undergo formal GCP training. The primary training for GCPs is the Collaborative Institutional Training Initiative’s CITI program (www.citiprogram.org), which is designed to provide research ethics education for those in clinical research. Biannual training on the rights and welfare of study participants should also be completed through free courses such as the National Institutes of Health’s Protecting Human Research Participants program (phrp.nihtraining.com).

KEY POINTS TO KEEP IN MIND

It is not unusual for first-time investigators to underestimate the amount of time involved in clinical research participation. Because involvement with clinical research most certainly means additional work, physicians who have busy patient practices may find it difficult to manage the combined workload. Although the time spent with each study participant may not be any greater than it would be with a nonstudy patient, the amount of time spent on administrative duties adds up. For this reason, it is important to have clinical study staff that are experienced and trained in the required clinical trial procedures. Perhaps the most important study staff member will be a designated study coordinator who will become the right-hand man or woman of the PI and can help relieve some of the administrative burden, allowing the clinician to focus on the study participant and patient care.,

It will also be important to choose the right clinical trial for your practice. This is why extensive research and planning is critical before jumping into clinical research. You will need to clearly understand your current patient population, which means knowing their demographics, what therapies they have been treated with previously, and the duration and severity of their retinal disease. Such knowledge will help you choose a clinical trial accordingly.

Also, consider whether your practice is equipped with the proper diagnostic and therapeutic equipment. You will likely need to reconfigure the layout of your practice to plan for study visits—sometimes including time-sensitive procedures that will occur side-by-side with your normal practice. Sponsors will want to know that your practice is prepared to execute the trial effectively. While each study is different, almost every one will require a secured room with a locking door to store the investigational product.

BCVA is an important endpoint in most retina trials. To ensure high-quality capture of this data and that the assessment is consistent across all subjects, a sponsor may request that a trained individual visit your site to review the length and illumination of the lane where visual acuity is measured, inspect the quality and placement of the ETDRS chart, and certify your staff on the process for refracting subjects and obtaining a BCVA.

Imaging is another key component of many retina trials. This includes imaging with equipment that your practice typically uses, such as a camera for fundus photography and fluorescein angiography. However, some trials may require use of a specific make or model of a machine and the completion of a certification process for the device and operator. For example, a spectral-domain optical coherence tomography scan may be required per the study protocol, along with certification that the device performing the scan can transmit encrypted data to a central reading center in a manner consistent with the regulations of the Health Insurance Portability and Accountability Act. The staff capturing the images must also be certified in the process for data acquisition and submission, which standardizes the method for collecting images across the study and ensures compliance with the protocol.

BE AN INFORMED INVESTIGATOR

For many retina specialists, participating in clinical research is extremely rewarding for a number of reasons (eg, exposure to cutting-edge therapies, techniques, and technologies; involvement in publishing reports and articles). However, thrusting your practice into a study without careful consideration is unwise. Take the time to do the research, be prepared, line up your resources, and make informed decisions. Also, take full consideration of the feasibility process to determine whether a particular trial is a good fit for your practice. As a PI, strive to maintain your typical office atmosphere with patients, while still providing the increased level of attention required for clinical study participants. This will help to facilitate success in both arenas. n

Aron Shapiro is vice president of retina at Ora in Andover, Massachusetts.