Wilmot Clinical Trials Office Steps Up Its Game
Many small business growth stories — whether it involves a food retailer, a fashion brand, or even Zoom, which was much less known until 2019 — have things in common with the Wilmot Cancer Institute’s Clinical Trials Office: They all require infrastructure, recruiting, and acting swiftly and creatively to change.
At Wilmot, however, when improvements are underway — when a major new software system goes online, for example, or a new governing charter is thoughtfully devised — it’s not as if business can pause, even for a moment. Cancer is everpresent, and patients, rightfully so, expect and rely on cutting-edge treatment. Clinical trials are often the best way to get those therapies, and in keeping with the mission of an academic medical center, Wilmot is committed to continually moving science out of laboratories and into studies that can directly benefit people with cancer.
Against this backdrop, Wilmot’s Clinical Trials Office, known as the CTO, set out to climb a big hill during the past few years.
The goal is to meet the strictest requirements by the for the way CTOs are organized and operate. Wilmot is pursuing a special grant awarded to the most elite cancer centers in the country, and as part of this effort, the NCI demands a comprehensive evaluation. In response to the upcoming review, the CTO began plotting a strategic path for growth and improved efficiencies. All Wilmot programs — research, community outreach, education — are going through the same thorough analysis, but the CTO has been making its changes while simultaneously providing cancer care, and in the midst of a pandemic.
Because health care is always evolving, producing a “version 2.0” of the Clinical Trials Office has required the team to find new routes to reach the summit, says David Linehan, M.D., Wilmot Associate Director
for Clinical Research, who is ultimately responsible for the office.
External consultants, including some of the nation’s top cancer center brain trusts, have looked under the hood and given valuable advice, Linehan says. They’ve assured Wilmot leaders that its CTO will
shine among the best.
“It’s been transformative,” he says of the CTO’s achievements so far, “and it couldn’t have happened if the 90 or so staff members had not pulled together.”
One way in which Wilmot stands out is that it was able to keep up patient enrollment in clinical trials during COVID-19. Nationwide, there were legitimate concerns that clinical cancer research would come to
a standstill. But while many cancer centers saw enrollments in studies drop, Linehan says, Wilmot in 2020 had a record number of individuals with cancer enrolled into treatment trials.
Finding the Right Leaders
A key to success in any venture is to find someone who has done it before.
Wilmot found its authority when it recruited Helen Peck, R.N., M.A., O.C.N, as executive director for Clinical Trials Operations. Linehan says Peck is the true champion of change at the CTO: “She is best in class.”
Her recruitment was strategic. When she joined Wilmot a few months before the 2020 pandemic, she had just helped the University of Miami Sylvester Cancer Center to successfully complete the same rigorous NCI evaluation that Wilmot is undergoing. Before that, she was in Detroit for 10 years, when the Karmanos Cancer Center was similarly vetted twice by the NCI.
Peck, in turn, credits everyone else at Wilmot, from the executive ranks to the frontline.
“The support here is phenomenal,” she says. “Coming together, embracing change, and adapting on the fly: You can’t do any of that in isolation.”
Peck does single out four people in particular for their critical leadership: Jamie Littleton, M.S.N., R.N., who stepped in as interim director of clinical trials operations and has since been hired into that position; Tina Bowdish, M.S., director of regulatory finance and affairs; Erin Cebula, head of quality assurance; and Paul Barr, M.D., the CTO medical director. Faculty oncologists, who are key stakeholders and users of CTO services, have also been required to step up their game by relearning how to run studies in a heavily regulated environment, with new software, evolving priorities, and a changing staff.
Peck also credits the patients who place their trust in research.
“You can get caught up in organizational charts, but what’s really important is protecting all of the things that go on behind the scenes to maintain patient safety and their rights,” Peck says. “We take pride in providing a service that impacts lives.”
Creative Solutions
Most people may never see or understand the back room of a CTO. Each job — study coordinator, regulatory coordinator, data analyst, nurse, finance specialist, technical associate —provides support to approximately 60 cancer investigators.
Wilmot’s investment in the CTO has been extraordinary, Barr says, and has allowed it to achieve a breadth and depth like never before.
The team has taken on an endless list of tasks, starting, for example, with writing a new mission statement and governing charters for all aspects of the CTO; closing trials that were underperforming; implementing a new data management system that tracks all studies in real time; and creating a more desirable workplace with career ladders and better communication.
The National Clinical Trials Network, an NCI-funded cooperative group system in the U.S., also awarded Wilmot a six-year grant to support patient enrollment in national studies. Wilmot is one of 32 recipients in the country, and Barr says it is more active than most other cancer centers in terms of accrual.
Like many workplaces, however, the growing CTO also faces post-pandemic challenges, such as staff turnover and filling the open positions. Barr speaks weekly to his peers — medical directors at other clinical trials offices throughout the country — and hears that a national shortage of healthcare workers and clinical research coordinators is having an impact everywhere.
But by leveraging the University of Rochester’s assets, they are working on a solution. Peck and Barr have been reaching out to bright undergraduates with an interest in science, to fuel the CTO career pipeline. The CTO is also partnering with Emergency Medicine’s research training program (EDRA), to develop a route for new graduates who have already shown a passion for research and have received unique training as part of their undergraduate degree.
Peck also got creative when it became clear, in March 2020, that COVID-19 would bring unprecedented challenges to the CTO. She dusted off a hurricane disaster plan she had used in Miami, and quickly got to work ensuring that extra communication was in place for patients and employees, and that the pillars at the CTO would not collapse.
Reacting to change quickly is common in business but less so in the academic world.
For that reason, the team takes pride in its ability to “build an airplane as you’re flying it,” Barr says — all while managing an avalanche of new treatments, some of which are on the fast track to U.S. Food and Drug Administration approval, to improve cancer care.
“The one word is ‘teamwork,’ and that’s an essential element here,” Peck says. “Teamwork makes everything possible.”
What is a clinical trial?
Cancer patients may have several treatment options, depending on the type and stage of their disease. One option may be a clinical trial, which are also known as “clinical studies” or “research protocols.” Sometimes a trial is the best option. Clinical trials seek to answer research questions that may improve therapies or ways of preventing cancer or enhancing quality of life. They evaluate new treatments and sometimes answer genetics questions. Most trials have eligibility requirements. Choosing to participate is an important, personal decision and one that only a patient can make, often with the help of physicians, family, and friends.
Views from Wilmot's CTO Staff
Chelsea Marsh, regulatory coordinator
“Recently, the FDA has been auditing an experimental drug at Wilmot that’s seeking approval to go on the market. It’s probably the most stressful and exciting part of the clinical study life cycle for us regulatory coordinators: Everything has to be completely in order for the inspector. This is my first audit, and it’s on a gynecological study that I’ve worked with for a long time, so it’s kind of a proud moment. That’s the thing about being a regulatory coordinator — we don’t see cancer patients directly but this moment is what we work toward, when we can say, ‘This treatment helped people and made their lives better. Let’s make
it available to more people to improve their lives as well.'
I didn’t know much about cancer when I started working here. I was a linguistics student at UR before working in research administration. Coming to Wilmot was a real eye-opener about what patients and their families have to go through. No amount of reading study protocols can help us fully appreciate that struggle, but we can still work hard to provide the best care and treatments available, and to make sure those treatments are always getting better.”
Jessica Wavercak, R.N.
“I’ve always had a certain love for clinical trials because a clinical trial actually saved my life. At age 4, I was diagnosed with acute lymphocytic leukemia, and I relapsed when I was 10. My two best options were a bone marrow transplant, which was fairly new in 1996, or a clinical trial. My parents opted for the trial. I remember it like it was yesterday: frequent blood tests, spinal taps, biopsies, cranial and spinal radiation, and so many hospitalizations. At the time, I didn’t realize how much my illness affected my family dynamics, the whole family. My mom quit her job to care for me. My dad worked two jobs and took care of my three older brothers. I understand the stress and hardship of illness, and I am grateful for my family’s support and positivity. Without them, I honestly don’t know if I would be here today."
"I also never imagined that I would be helping patients get through where I once was. As a clinical trials research nurse, my role is new at Wilmot; I am a liaison between the clinical trials team and the medical oncologists, mostly working with leukemia patients. I get to come in every day and be part of this huge network of like-minded individuals to provide safe and quality care. Every time I talk with a patient, I remember the struggles I’ve gone through and continue to face — and I’m also reminded that my trial, years ago, ended up saving the lives of many young cancer patients.”
Carly Whritenor, data manager for multiple myeloma
“I’ve been in my current position for almost two years now. Prior to this, I had always been in roles where I interacted directly with patients —I never thought I would love a ‘desk’ job so much! I still feel connected to patients as I collect data for clinical trials and observe their progress. I have so much passion for research because it’s allowing our patients the opportunities to get medications that they wouldn’t have otherwise. And once these drugs are FDA approved, even more people will have access to them to improve the status of their disease. I feel honored to be a part of the cycle, where clinical research is evolving so quickly to
help people."
I work with a very small team and we’ve really pulled together during the challenges of the last 18 months. It was not an option in our minds to allow our clinical trials to suffer, no matter what else was going on. The bottom line is that we’re here for our patients to get them through what could possibly be the worst day, week, month, or year(s) of their lives. Being part of a tight-knit team with the same passion makes all the difference.”
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