Clinical research is a vital part of maintaining the constant innovation we see in our field of ophthalmology. The reality is that clinical research can’t happen without patients. Despite all of the capital raised and the work put into lab research for a new drug or a new surgical product, trial enrollment can be a challenge. This article looks at the many factors that affect patient enrollment—including those that keep them away and those that encourage them to participate—and explores what we can do to continue to make the patient experience exceptional.
WHAT KEEPS PATIENTS AWAY?
Fear.
Not everyone shares our excitement about clinical trials. For the most part, whenever I mention these opportunities, some patients immediately misunderstand me and imagine I’ve asked them to play the role of a “guinea pig.” A 2005 Harris Interactive online survey of 2,261 US adults found that the three greatest perceived risks of participating in clinical research are possible side effects (47%), health risks (32%), and unproved therapy (9%).1 Some patients are initially into the idea but then get turned off when they hear that they may only get a placebo. Others may be intimidated by the consent forms. However, there are always a few patients who are willing to consider the trial, if the physician is willing to put in the “chair time.” Word of mouth is often the starting point for awareness and consideration, and taking the time to answer questions and explain the risks and benefits is vital. When seeking information about clinical trials, 60% of people would go to their doctors.2 Another great resource for patients is our back-office technicians. All of our clinical coordinators have back-office technician training and can usually cover a lot of the clinical questions that may come up before I enter the room.
Dr. Goldberg's five steps to creating a positive experience for patients and staff members alike.
Lack of awareness.
Low enrollment is attributed to many factors and varies per study. If more people knew about clinical trials, there would certainly be greater participation. Not as many clinicians, let alone eye centers, provide trials. Therefore, less overall public health information is known about them. Even though word of mouth may be a great way to spread the word about one trial, I find that sometimes participants in trials will rarely speak about clinical research with any friends or family members. With the advent of our office website, social media platforms such as Facebook, pamphlets, and occasional ads in local papers, we’ve been able to improve our ability to spread the word about clinical trials.
Doubt about eligibility.
Some patients assume that there aren’t any clinical trials that apply to their condition, or they doubt they’d be eligible to participate. Unless it’s brought to a patient’s direct attention as an option, some people may never consider enrolling. A Research America poll found that 80% of 1,000 respondents claim a physician’s recommendation is an important factor in deciding to participate, yet only 22% of patients said a health care professional has talked to them about it.3 Also, sometimes patients are confused about their insurance. Occasionally I have a Medicare or HMO patient who does not think he or she is eligible because of his or her insurance plan. Each trial may be different, but it’s important to have good answers to all of these questions for patients with various plans.
Inconveniences.
Some patients can’t commit to the time required to participate in a clinical trial. Others may find the available hours incompatible with their schedule. Glaucoma trials with diurnal curves that require pressure checks four times a day can definitely be a challenge for patients who work full time. Travel can also be an issue for patients who can’t drive. Other social and economic disadvantages contribute to some populations being underrepresented. I had one patient who took three buses to come 5 miles to make her trial visits.
Exclusion via criteria or protocol.
Some patients are more than willing to participate but come to find that they can’t enroll because of rigid inclusion or exclusion criteria. Our office has also had to disqualify interested patients because they did not sign and return the informed consent form properly. Sometimes patients have a positive result from the trial but are dropped because they run into a health problem afterward that is unrelated to the trial.
WHAT MOTIVATES PATIENTS TO PARTICIPATE?
Advancing science.
Ophthalmic clinical trials can yield better ways to detect, diagnose, and treat ocular diseases. Knowing these potential advancements motivates patients to want to help improve medical knowledge. They see the advantages this could offer to future patients who may also develop their conditions. In one survey, the opportunity to improve the health of others was an important factor in the decision to enroll for 86% of people.3
Access to promising treatments.
When making treatment decisions, 89% of respondents said that the opportunity to possibly improve their own health is an important deciding factor to participate in a clinical trial.2 The idea of receiving the latest treatment before it’s widely available can be an exciting opportunity. I have several patients with significant tear deficiency syndrome who have tried drops, gels, steroids, and cyclosporine and have never achieved significant relief. These patients are always very excited to try new pharmacologic therapies.
Receiving compensation.
There are always a few patients whose primary motivation to enroll in trials is to earn the honorarium. Seventy-eight percent of people said that whether they would be paid is an important factor in the decision to participate in clinical trials.3
SUMMARY
Many patients have great experiences with clinical trials and become repeat participants even after having a positive experience with just one clinical trial. Of the patients who have participated in a clinical trial, 95% said they would consider enrolling in another clinical research study.3
Clinical trials aren’t for everyone, but it never hurts to reach out and introduce the topic to patients. Patients admire treatments that could potentially help them as well as future patients. We all want to see the field of ophthalmology continue to evolve, and we should take the time to thank those patients who have participated in clinical trials and do our best to continue to make the experience special.
1. CSR, Incorporated. Evaluation of Patient Recruitment Strategies—Phase I Feasibility Study. March 31, 2006. Available at: https://aspe.hhs.gov/evaluation/fullreports/06/8384.pdf. Accessed March 21, 2014.
2. Zogby Analytics for Research!America. National Poll on Clinical Research. June 2013. Available at: https://www.researchamerica.org/2013clinicaltrialspoll. Accessed March 21, 2014.
3. The Center for Information & Study on Clinical Research Participation. 2013 Perceptions & Insights Study: Report on Study Participant Experiences. 2013. Available at: https://ciscrp.org/professional/reports/study-participant-experiences-2013-ciscrp-study.pdf. Accessed March 21, 2014.
