Reflections on a Career in Oncology Clinical Research

Clinical Researcher—November 2018 (Volume 32, Issue 9)

CAREERS—PASSING IT ON

 

Beth Cuccia, RN, BSN, MHM, is a Senior Project Director of Oncology at Syneos Health, a leading biopharmaceutical solutions organization. She has more than 25 years of experience in research, including 15 years of experience with oncology studies. In addition to overseeing studies and molecule programs, she works on company initiatives and in a project management mentoring program.

Q: How did you first become involved with clinical research and oncology trials?

A: I graduated from the University of South Florida with my BSN. My first job was as a floor nurse for several years on a medical-surgical floor at a large metropolitan hospital in South Florida. During that time, the floor I worked on created the first dedicated oncology treatment unit. I lost my mom to cancer just before I graduated from nursing school, and being able to care for these patients the way my mother had been cared for became an important driver in my subsequent career choice. While I moved on to focus on work in intensive care units (ICUs) for the next 10-plus years, my experiences with my mom’s cancer and the oncology patients and their families remained with me.

When I relocated to Charlottesville, Va., I was looking for something a little different and less stressful than the ICU, and this led to my foray into clinical research. At the University of Virginia’s Neuroclinical Trial Center (NTC), I was hired to utilize my nursing background—initially to review and clean data for a subarachnoid hemorrhage study. As I took on more studies, I added project management, clinical monitoring, case report form design, and regulatory document review to my repertoire of job responsibilities.

Five years after I began at NTC, we merged with Integrated Neuroscience Consortium, a site management organization based in San Diego. That merger was the genesis of INC Research, a contract research organization (CRO) with an initial therapeutic focus in central nervous system studies. As INC expanded into a full-service CRO handling multiple therapeutic areas, the company established an oncology-specific business. Leveraging my oncology work from my early career, I was right there to begin the company’s very first cancer trials. Today, the company has now further expanded through a merger with inVentiv Health to become Syneos Health, offering clinical and commercial solutions to customers.

Q: What changes have you seen in the oncology trial landscape during your career?

A: When I first began in oncology, studies were more open with their inclusion criteria—almost any affected patient could enroll. By contrast, now standard of care has evolved so much, and as specific targeted therapies are both approved and under clinical investigation, many studies include very specific genetic mutations in tumor typing. This makes enrolling a low percentage of patients with that molecular aberration even more challenging. At the same time, it allows for the right patients to be enrolled based on more targeted treatments.

There are so many new, innovative, and impactful cancer treatments now available as a result of clinical trials—certainly compared to when I first began in this field more than 25 years ago. However, there is still so much more to come; the pace of innovation in development of new oncology therapies (e.g., CAR-T cells, immunotherapy agents, gene therapy) make this an amazing space.

Q: Why choose oncology as an area of focus for a research career?

A: Oncology clinical research is challenging with novel drugs, first-in-patient studies, complex protocols, and cutting-edge science. It will always require individuals dedicated to improving patients’ lives and giving them hope for a cure.

Every study encompasses the same basic data requirements, but variables always exist that differentiate each study, even in the same type of cancer. The essential element in all studies is to first protect the patient while assessing potential new therapies. So whether you work in a hospital, at a research site, as a lab tech in an oncology department, in basic lab research, or have no experience at all, there are numerous opportunities for diverse, expanded career paths in oncology, whether it is within the pharma, biotech, or CRO space. Positions supporting/managing trials or monitoring the patient data onsite with a research team are just a few of the options.

You will never be bored, and there is nothing as satisfying as working on a study for an investigational product and seeing it approved and become standard of care, potentially benefitting someone you know and love. In my career, I’ve been able to support teams that have driven multiple drugs to a new drug or biologic approval for indications such as breast cancer, which later in my career became an even more personal matter as I dealt with my own diagnosis of this disease.

Q: Why have you stayed at the same CRO/group for 25 years?

A: First and foremost, I have stayed because I work with fabulously dedicated and supportive individuals whose passion for oncology and new medicines and focus on keeping patients safe while assuring quality data is infectious. Because the company has created a dedicated oncology team, I’m able to work alongside a group of people like me, who are specialized in this therapeutic area.

Additionally, the company has grown over the years, providing tremendous opportunities for career advancement and the ability to take on new roles while still being focused on oncology, which is my passion. The evolution of the company through its growth has propelled best practices and attracted new, dedicated individuals to collaborate with, while keeping to core values. A recent advancement incorporates a commercial component which expands our ability to bring treatments to those who will benefit by working with companies to shorten the time from bench to bedside. Our goal continues to be providing more treatment choices for patients as expeditiously as we can.

During my time here, I have had the opportunity to work with large pharmaceutical companies with pipelines of drugs, as well as very small biotechs with a handful of employees and a potentially innovative compound; all with the goal of approving a new therapy. Every study and every company will have different levels of experience and requirements for support.

There is also variety in the types of studies. From small Phase I to global Phase III studies, I have had the opportunity to work with team members from all over the world and travel globally. It is so interesting and empowering to visit new cultures and learn about the opportunities (and constraints) for oncology development in different countries.

I have worked, and continue to work, on initiatives for process improvement—some that allow a more complete and comprehensive review of patient data to look for trends that protect patient safety and others that provide comprehensive, yet streamlined, instructions for work processes. At this point in my career, I am still overseeing studies, but am also involved in our mentoring program. I have always tried to pass along my experience and same level of passion for this work that others have generously shared with me. The mentoring initiative is a wonderful program that recognizes talent and provides training to promote support staff or clinical research associates into project management…and beyond.

Q: Do you have any closing thoughts for readers who might be interested in following a similar career path?

A: If you want to make a difference, be challenged, and work with individuals dedicated to their work, oncology research is a great option. I have met amazingly brilliant people who work tirelessly through successes and failures to bring new treatments to the world. Originally, I had thought this was a temporary career move…but here I still am, 25-plus years later. I have no regrets, and if you decide oncology research is for you, I don’t believe you will regret it either; this is a challenging, but spectacular and innovative time for cancer therapeutics.