Through his own participation in a medical trial, our own Mark Sorrentino gained new perspective on what being a patient in a clinical trial is actually like, and the demands it places on our study participants. Read about his experience below.
At the end of 2020, following a tough year and a cross-country move, I sought medical assessment of a swollen lymph node I’d noticed over the past few months. The diagnosis was disheartening but not entirely a surprise—as a former practicing pediatrician, I knew cancer was a possibility, and my test results came back conclusive for cancer.
I was grateful to learn that my prognosis for a cure was high. I was a great candidate for a soon-to-be enrolling clinical trial with a reduced amount and duration of chemotherapy and radiation compared to the standard of care. Having worked in clinical research now for over 20 years, I was absolutely interested in a trial that expected to result in the same cure rate with a much less toxic treatment plan.
Though doctors and researchers are all patients themselves at one point or another, this experience opened my eyes far wider to the reality of clinical trial participation. As the Vice President of the Center for Pediatric Clinical Development and the Center for Vaccines and Emerging Infectious Diseases, my teams and I explore ways to make participation in clinical research easier and more accessible to patients and their families. Through my own participation these past few months, I’ve gained new perspective on what being a patient in a clinical trial is actually like, and the demands it places on our study participants.
From the start of my participation, I used my understanding of clinical research to my advantage. The education on the clinical trial was easy for me to understand. I wasn’t fearful about participating in a trial, as many patient and families are due to their unfamiliarity. I also was not intimidated by the consent process—admittedly, I didn’t even read most of it since it was 20 pages long. My medical training also allowed me to understand my treatment options on a much deeper level, and I was able to actively participate in the discussions about my therapy. This advantage made me aware of the importance of strong, easy to understand education materials and consent forms. Helpful and informative investigators also make all the difference.
These pieces are key to a good experience for the patient and to fulfilling patient enrollment. Our industry must rely on quality engagement of our site teams. However, we can also supplement the experience by utilizing high quality education materials for patients that help them understand both their disease and the clinical trial. My team partners with Jumo Health to provide resources to our participants, ensuring both the child and the parents are comfortable with this new world of illness and clinical research.
It’s also important that every piece of trial material we provide to our patients is easily digestible. When I reviewed my treatment schedule, the information wasn’t laid out in an easy-to-understand table, so I requested the schedule of events the clinical research team used. Of course, most patients would not know to request this, or even benefit from this additional unfamiliar format. In what is already a confusing and overwhelming moment, it’s important that we are mindful of making schedules easy to understand. That way, patients know what they’re committing to.
I also noted how incredibly lucky I am to work at a company like PRA, where I received great support and flexibility for undergoing treatment while continuing my work. I worked when I could and took breaks when needed. I drove an hour each way to each appointment, so these appointments did take up 3-4 hours each day for a few weeks. Besides travel and treatment time, there is also the unknown—such as how I’d feel each day. This level of commitment to treatment requires a flexible lifestyle and employer that not every patient has—or close to it—and can amount to extreme difficulties for patients trying to maintain a job during treatment. It’s important as researchers that when we are developing protocols, we consider how real-life schedules and priorities fit around schedules of events.
In addition to the clinical trial appointments, I also had my regular standard of care appointments. They weren’t guaranteed to overlap on the same day. Because of my level of comfort based on professional experience in this environment, I pushed back on the coordinator and specifically requested to have these schedules align. At one time, I even requested to move an appointment to be fulfilled through telehealth—an option not given to me, but once requested, was accommodated. Again, my understanding and comfort level with medical care and clinical research afforded me advantages other patients don’t have. When possible, it’s important we work with our site teams to coordinate care and trial participation to overlap as much as possible.
This scheduling experience, in particular, helped me understand the advantage of decentralized clinical trials for the patient. Though I had much personal flexibility to receive the treatment I needed, it was still a heavy burden to drive the distance every day. The notion that “even one less visit makes a difference to a patient” resonated with me as a participant—every appointment presents scheduling challenges. At each appointment, I was presented with 50 pages of surveys to complete by hand. I could have completed them online around the time of the appointment from home, making it easier to work into my schedule. I also had regular lab work scheduled during these appointments that could have been conducted at home and re-assessed for need. Additionally, the amount of blood that was taken from me each appointment left my arm purple and numb. I questioned if all this blood was really necessary to prove efficacy.
I’ve now passed the active treatment phase of the trial and am in the follow-up assessment stage that I must complete every 3-4 weeks. As researchers, we rely on altruistic patients to fulfill participation in a clinical trial beyond when the schedule of treatments provides clinical benefit to the patients. Though follow-up is unavoidable, every means necessary to make the participation easier on the patient is worth it, not only for them but for the development program. I have a few more years of participation by appointments, and though I will remain committed, I certainly understand why participants would choose to drop the trial. Home health, telehealth, and other decentralized means have the potential to decrease dropout rates significantly and reduce our reliance on altruism.
While I am in a position to accommodate the needs of this trial now, I have not always been— and many patients are not. When I was a hospital-based critical care physician, I could not have accommodated this commitment. I no longer have young children at home who rely on me for making it to school, eating their meals, or constant supervision. My wife is able to help with my care and take on some of my responsibilities around the home. If we want to make clinical research a care option, decentralized clinical trials will enable it to be a reality for a much wider percentage of the population.
Mark will be continuing in the trial for the next few years.
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