Clinical Researcher—December 2021 (Volume 35, Issue 9)

SITES & SPONSORS

Elizabeth Weeks-Rowe, LVN, CCRA

 

When I transitioned from being a study coordinator to the clinical research associate (CRA) role, I understood that I would no longer interact with study patients. The shift to industry signified the end of the face-to-face patient engagement that I would deeply miss. For me, one of the highlights of being a coordinator was developing relationships with study patients through the educational aspects of informed consent, and through learning a patient’s history during intake and their overall story during subsequent study visits.

Patients entrust study coordinators with their health, and coordinators rely upon their transparency to ensure patient safety and credible data collection. This reciprocity creates a partnership framed by compassion, understanding, and the aligned goals of health/discovery unique to the study patient/practitioner relationship.

The View from the Other Side

I was grateful for the next step in my clinical research career and accepted that I would now become acquainted with study patients via source/medical record review during monitoring visits. I became an oncology monitor early in my CRA career, which required me to learn difficult drug calculations, Response Evaluation in Solid Tumors (RECIST) criteria, and the fine points of identifying inconsistencies in pathology/lab results. This created a solid foundation for understanding diverse disease processes.

The first oncology study to which I was assigned was a Phase III advanced solid tumor study with a randomized, double-blind design. The patients were all treated with standard of care chemotherapy and then either assigned to investigational drug or matching placebo. The investigational agent targeted tumor growth, and there had been incredible results in the previous trials conducted. This was the pivotal trial, with extensive patient assessments to support the critical endpoints. It was my responsibility as the CRA to ensure the procedures had been completed in compliance with the protocol, and this was a task I took very seriously.

The investigational sites to which I was assigned varied from large academic health institutions with high enrollment numbers to smaller oncology medical practices with understandably fewer patients. One of my favorite sites was a small oncology practice with two physician oncologists who took turns serving as principal investigator (PI) on the studies they conducted. They did not conduct a large number of studies; the primary study coordinator was their only full-time employee, and she was backed by a part-time research nurse and the medical office manager/research administrator.

The research department was part of the medical practice and study patients were seen in the same clinic area as the practice patients. The research department was located beyond the patient examination areas and consisted of a large room that housed the coordinator’s work area, the lab processing area, and study drug storage and supplies. The monitoring space was the investigator’s office, or an empty desk in the back of the research department. Study assessments such as imaging and local safety labs were completed at the hospital next door to the practice.

Though the research space was small, they leveraged their resources to conduct ethical, quality research. They had only enrolled three patients in the study, all of whom were still in the treatment phase. The atmosphere at this site was warm, without formality, and the study patients were treated like family. They would frequently walk back to the research work area to greet the study coordinator and other staff before their study visits began. Their participation in the study, even if it did not benefit them, would help further research/treatment for their disease.

Though I did not know these patients, I knew their stories of courage and sacrifice from review of their medical records, and by allowing this review, these patients had helped me become proficient in tasks that were crucial to my role. After a difficult day, reading their charts gave me time for perspective, pause, and a reminder of what was truly important in life.

Live and in Person

“Larry” was a study patient whose story touched me deeply. He was in his late 60s and had been on the study for about a year. Though no one knew, in theory, to which treatment he had been assigned, he was steadily improving. His lab values were within normal limits and his tumors were shrinking. His status was steadily changing from terminal to recovery, and the narrative of each study visit described his joy. His gratitude came alive from the dictated notes in the medical record I reviewed. I never imagined I would witness it in person.

During a routine monitoring visit, I was reviewing data queries with the study coordinator at her desk when a gentleman sporting a Yankees tee shirt and a happy demeanor entered the room. The coordinator introduced me as the monitor for the study in which he was participating. Before she could utter his name, I knew this was Larry, and I was a little dumbfounded that I was being introduced to a study patient, not to mention that this was Larry in the proverbial flesh.

He smiled, shook my hand, and without hesitation informed me that he knew he was on the study drug. Next followed a straightforward testament of his improving health and outlook due to study participation. “Your company is doing a remarkable thing,” he said. “I have never felt better and am taking my grandson to a baseball game next week.” I struggled to reply, but managed to thank him for his words and study participation before the coordinator escorted him to the examination room for his study visit. I stood rooted to the spot, alternatively stunned and grateful over this rare encounter.

What once lived only in the pages of a medical record—Larry’s story with its reams of paper representing diagnosis, devastation, treatment, illness, set back, and recovery—had come alive to me with that introduction, and his testament regarding the miracle of clinical research. I had the honor of witnessing the most pivotal chronology of his life, revealed willingly in the name of discovery. That moment represented one of the main reasons why I work in clinical research; the path of discovery that results in hope and healing to patients in need.

Elizabeth Weeks-Rowe, LVN, CCRA, (elizabethwrowe@gmail.com) is a former clinical research coordinator who now works in site selection and education in the contract research organization industry. She last wrote for Clinical Researcher in September on “The Qualities to Evaluate in Your Site Evaluation Representatives.”