The personal side of clinical trials: life at the BCC

Pager buzzing frenetically in my hand, I jog through the hallways of UCSF’s Breast Care Center to consent a patient for one of the clinical trials that I am helping to coordinate. Breathless (and, admittedly, a tad nervous), I arrive at the door of the patient’s exam room, compose myself and knock. I hear a muffled “come in,” and I turn the handle.

This scene has repeated itself several times over my past four month’s at the Breast Care Center. What has not repeated itself is the scene I find on the other side of the door. Some patients are surrounded by a mob of friends; some are with sisters, partners, children; a few are alone. Some are in their 70s, and some are only two or three years older than I am. In the hour or so before I am paged, most have received the news that they have breast cancer, and so I often find tears or stunned gazes. But I also meet stoics, and the occasional patient whose response to meeting me is a broad grin and a joke about how young I look. As I discuss the trial with these patients, their responses are equally variable, and one of the most challenging aspects of my job this year has been learning how to guide and tailor these conversations for each patient and every situation.

For many of us, myself included, the words “clinical trial” have mixed connotations. We all benefit from successful clinical trials—they are the gold-standard by which we determine if new therapies are safe and effective. But these words also conjure stories of ethical misconduct, fibbed data, and incomplete analysis, not to mention the risks of untested treatments. Before I arrived at UCSF, I knew what clinical trials were. I understood the concepts of control arms, of double-blinding. I’d read about trials that had brought miraculous new drugs to market, and others that dragged on for years, eating millions of dollars, only to yield null results. But I had never really thought about how these trials are actually orchestrated. Who makes sure that extra study lab tests are run for study patients? Who dispenses experimental medications to patients? Who analyzes their specimens to determine how patients respond to new therapies? How does a patient’s complaint of nausea make its way, several years later, onto the list of expected side effects for a new drug? Who tracks patients five or ten years after they have completed treatment to assess survival? While a few doctors and scientists will write their names on the publications resulting from a trial, the entire operation of a trial actually involves a huge cast, a massive engine with interconnected parts. My job as clinical coordinator is to make sure that the spinning parts remain greased—I schedule appointments, I enter data, I answer patients’ questions about the trial, I make sure that patients, tissue specimens, chemo orders, physicians, etc. arrive at the right place at the right time and for the right purpose.

The trials I am helping to coordinate assess new chemotherapy drugs to treat breast cancer, as well as a host of biological markers, tests and imaging techniques. Our hope is that not only will we find new drugs to treat breast cancer with, but we will also figure out how to tailor treatments to individual patients, using the specific biology of the patient’s tumor as our guide (see a recent Wall Street Journal article about one of the trials I am working on here: http://online.wsj.com/article/SB10001424052748703882404575520190576846812.html).

The broad scientific aims of these trials are certainly inspiring, but one of the unexpected benefits of my job is the relationships I’ve been able to build with patients. I see each of our study patients about once a week during her several months of chemotherapy. I hear about children and grandkids, I swap travel stories and eat home-made chow-mein. And I listen to each woman describe her experience on the physical and emotional rollercoaster that is breast cancer treatment. It is these personal connections that are ultimately the most rewarding aspect of my job.