May 14, 2024

Finding Your “North Star”: Why Patient Stories Are the Bridge between Clinical Trial Operations & the Human Experience

The following patient story comes from Kyle Baker, Slope’s Content Marketing Manager. Kyle previously worked as a project manager in the central lab space for several years, but is now focused on leveraging his passion for writing and storytelling to inspire innovation and change in clinical trials. Pictured above is Kyle on a school field trip with his Aunt Vicki (circa 2003). Vicki lost a hard-fought battle with triple-negative breast cancer in 2013.

At Slope, one of our five core values is, “Patients are paramount.”

If you work in clinical research in any capacity, this sentiment likely resonates with you too. Every single one of us, in some capacity, has been or will be touched by the devastation of disease. Maybe we’ve lost a loved one to cancer. Maybe we know someone who lives with a rare disease. Or maybe we ourselves struggle with a chronic condition that impacts our quality of life. 

We know that our time on this Earth is finite, but it’s what disease takes from us that troubles us. We’re heartbroken by the countless lives cut short, robbed of the ability to experience everything that a fulfilling life has to offer. We’re depleted by the anguish of watching a family member or friend deteriorate before our eyes — which, for millions of us, also demands that we play the role of “caretaker.” We’re left dejected by the opportunities that we lose at the hands of something we can’t control: the job we can’t hold because of chronic pain; the experiences we lose out on because of mental illness; the milestones we can’t reach because of physical limitations.

Every single one of us has endured loss, pain, and suffering to varying degrees and in various forms, both physical and emotional. Our lived experiences with these feelings and emotions may be unique, but they are universally understood. 

For those of us who orchestrate the logistics of clinical trials behind the scenes, our stories and the stories of others should inform and motivate our work. But we find ourselves in a bit of a conundrum, because the very nature of our work removes us from the patient. Strict regulatory and legal requirements are necessary for protecting patient privacy, but these policies seemingly reduce patients to numbers in a spreadsheet or a database, devoid of the human behind the data.

As someone who has touched clinical research in various capacities throughout my career, this is admittedly something I have struggled with. I’m someone who often relies on empathy for inspiration, craving a tangible connection to the people our work supports. I long to know their stories, leveraging them as fuel to incite action and inspire change.

But patient confidentiality forces us to get creative with where we derive our sense of purpose, and in many cases it requires us to look within and around us. We recognize that we have a vital role to play, but it’s easy to lose sight of the bigger picture when we are in the weeds with meetings, spreadsheets, documents, and emails. 

So how do we break through the corporate churn of the business world and stay connected to the “why” behind our work? Many of us look to our own “North Star,” an internal compass that gives us a sense of meaning and purpose when patients in our industry are de-identified by design. For me, that North Star is my Aunt Vicki.

Vicki’s patient story is also a human story

I was 12 years old when my Aunt Vicki was diagnosed with advanced-stage triple-negative breast cancer (TNBC). If you’re familiar with breast oncology, you know that TNBC is a particularly heinous disease. Because it lacks receptors for estrogen, progesterone, and HER2, it’s incredibly difficult to treat — leading to an oftentimes unfavorable prognosis.

Vicki fought a nearly 7-year battle with cancer. In that time she had a mastectomy, experienced several rounds of chemotherapy and radiation, underwent surgery for two malignant brain tumors, and struggled with pain as cancer ravaged her body. Ultimately, Vicki passed away on October 1, 2013 — coincidentally the first day of Breast Cancer Awareness Month. She was just days shy of her 56th birthday.

Vicki’s story is an all-too-familiar one for many others who have also lost loved ones to cancer and other diseases. In my case, the untimely passing of a loved one marked a major turning point in my life — not only because I had lost someone incredibly important to me, but because I found myself coming to terms with a new reality just 6 weeks after I had started my freshman year of undergrad. At an age when most young adults are venturing out into the world on their own for the first time — when it’s natural to ask existential questions — I was thrust into tackling these questions head on. What is my life’s purpose? Why had fate been so cruel? What was I supposed to carry with me from this experience? To answer these questions, I had to reflect on what Aunt Vicki meant to me, both in life and in memory. 

Growing up, Vicki was one of my greatest role models. 14 years my father’s senior, she was hugely influential in his upbringing — and it was almost as though his admiration for her was passed down to me secondhand. I saw how much his big sister meant to him, and I yearned to have an equally profound connection with her.

If one thing was certain, it’s that Vicki made me feel incredibly loved. Unable to have children, she treated her nieces and nephews as if they were her own, and this manifested itself in many ways. When each of us turned 7 years old, she would grant us an exclusive membership to the “7-Year Club.” The induction ceremony included a special weekend getaway at her home in rural Indiana, where she would spoil us to our hearts’ content with fun activities — like dinners at our favorite restaurant, movie nights, and shopping sprees — along with a college savings account. Every Christmas, she would buy us matching Christmas sweaters that we would all (begrudgingly) wear while we posed for a family photo. When we reached high school, she would take us on an all-expenses paid trip to a part of the country we wanted to visit. When my cousin and I turned 16, we spent a long weekend with her in New York — a trip that I still look back on fondly. 

There were many qualities that I loved about Vicki — chief among them, the fact that she was a bona fide free spirit. Despite what the world told her she should be, she always marched to the beat of her own drum and asked important questions. I credit her, in part, for teaching me the importance of thinking critically and being true to myself.

Vicki was also an advocate for the most vulnerable among us. In her later years, she became a champion for indigenous people in the United States, specifically the Blackfeet Nation. Through her work, she fell in love with Montana — so much so, that it became like a second home for her. Vicki was also a vocal supporter of cancer research — a cause that, unsurprisingly, hit very close to home.

Vicki’s cancer journey was shaped by clinical research

Although my Aunt Vicki ultimately succumbed to her disease, her battle with cancer was hard-fought, and one that was directly influenced by clinical research. Early in her treatment, Vicki enrolled in a clinical trial for a drug that prevented micro-metastasis by inhibiting blood capillary growth after radiation. Her healthcare providers and our family largely credited this novel therapy with prolonging her life by staving off metastasis for a few years after her initial bout with cancer.

In the final months of her life, when the cancer had come back with a vengeance for a third time, Vicki was in talks to screen for a Phase I investigator-initiated trial (IIT) at a world-renowned medical center. Unfortunately, while Vicki wasn’t able to screen for the trial, the prospect of receiving life-saving treatment gave her hope until the very end.

An excerpt from Vicki’s final Facebook post, just over a week before her passing in the fall of 2013. The promise of an early-phase trial gave her hope in the final days of her cancer journey.

Over 10 years after Vicki’s passing, what can we learn — as clinical operations professionals and as fellow human beings?

This past October marked an entire decade since Vicki’s passing. As her loved ones commemorated this milestone, I found myself reflecting on the impact that Vicki has had on my life, both in her time on Earth and in the years since then.

There’s no question that Vicki’s journey has defined or reshaped the careers of several people in my family. Both of Vicki’s sisters and at least two of my cousins work in healthcare. Another cousin of mine and my dad both work in clinical trials. For all of us, I know Vicki has been, and will always be, our North Star — the guiding light, the inspiration, and the “why” behind our work.

Witnessing the success and the hope that Vicki derived from clinical research has compelled me to ask the daunting question, What can we do to make clinical trials even better for everyone else? Early in my professional career, I was surprised to learn just how much work was left to be done. I worked as a project manager at a major central lab for several years, and saw firsthand the need for a better way to execute clinical trials. On an almost daily basis, I was fielding frantic requests from sites, CRAs, and sponsors to ship expedited lab kits to a site; walking a site through how to build their own lab kit for a same-day patient visit for which they didn’t have sufficient inventory; resolving preventable lab queries so that lab results could be reported; tracking down or investigating missing samples; and much more. 

I saw firsthand the ways in which these preventable issues impeded progress in clinical trials, putting patients and study timelines at risk. Worst of all, no one in the industry seemed to have a viable solution to the most common problems we see with managing lab kits, patient samples, and the data that’s tied to those samples.

On the one hand, a corporate lens demands a focus on the inefficiencies and financial burdens that these obstacles produce. But if we look at the bigger picture, it’s really about patients. 

In my current role as a writer for clinical research professionals, I see myself as both a soundboard and a mouthpiece. Anything I can do to leverage my passion for storytelling and my knack for listening can ultimately contribute to amplifying and solving the most pressing challenges in our industry. As long as I work in this field, I hope to be a small part of the solution that removes obstacles to life-saving or life-improving treatment for the patients who need it most — and part of that endeavor involves uniting the industry behind a common purpose and a shared desire to come together for a common solution.

As I reflect on what Vicki’s legacy means to me within the context of clinical research, I think about everyone else who may have a Vicki of their own. I think about how innovations in healthcare are integral to saving and improving lives. As stakeholders in clinical research with the power to exact real change, we should be doing everything in our control to eliminate barriers to safe and effective treatment. Effective, efficient clinical trials are the only way we accomplish this.

I implore each of you to consider what you can do to humanize your work. Treat your data like it’s human — because it is. Think of patient samples as physical extensions of the patients themselves — because they are. Think about how you can leverage innovative solutions to not only eliminate risk for the patients on your trials, but to improve the likelihood that lifesaving treatments could get to more patients, faster.

I also encourage you to look within, identify your own “North Star,” and use your own personal stories as a source of inspiration. There’s no denying that the work that we do is complex, demanding, and fast-paced. When we’re feeling discouraged, tired, or lost, let’s remember what this work is all about and who we’re doing it for. 

And may we all lead by my Aunt Vicki’s example — to be advocates for the most vulnerable among us, to challenge the status quo, to always ask the important questions, and to lead with love.

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