Investigative drug services: A glimpse into the future
Ashley Lewis is a final-year PharmD candidate at the University of Missouri–Kansas City School of Pharmacy at Mizzou.
My recent rotation in investigational drug services (IDS) at the University of Missouri gave me a glimpse into pharmacy’s future. Working alongside my preceptor, Sierra Richard, PharmD, I was able to deepen my understanding of clinical trials and understand the evolving role of pharmacists in advancing patient care through innovative therapies.
Navigating clinical trials
During my rotation, I observed the rigorous processes involved in bringing new medications from research to clinical application. I was involved in the study start-ups of several clinical trials, during which I drafted detailed pharmacy budgets to justify our services and navigated through complex protocols and pharmacy manuals, pulling out the most critical information to create comprehensive dispensing guides.
After a trial receives institutional review board approval, IDS remains integral to the study’s ongoing management, including receiving, dispensing, preparing, and maintaining accountability for investigational products (IP). I had the privilege of completing all these operations throughout the month with my favorite part being assisting in both nonsterile and sterile compounding of IP.
Bringing a trial to the study site also requires intricate teamwork and communication. Over the course of the month, I had the opportunity to interact with physicians, nurses, and clinical research coordinators. From discussing protocol details to sitting in on site initiation and monitoring visits with trial sponsors, I was able to ask questions and contribute when needed. These experiences highlighted the essential coordination required for successful trial operations.
Patient-centered care and emerging therapies
Another highlight of my rotation was gaining insight into how investigational drugs are designed to address unmet medical needs. During the month, I was exposed to cutting-edge therapies including a study utilizing CAR–T cell therapy and another involving an implantable antibiotic device to reduce infection rates while minimizing systemic exposure. These innovations offer hope to patients, providing new options when traditional therapies have failed.
With a strong interest in oncology, I led several cancer study start-ups. In these studies, sponsors were often comparing their new IP to existing standards of care, underscoring the evolving nature of cancer treatment. This experience gave me insight into how new therapies are rigorously evaluated against current practices to advance patient care.
Additionally, I gained experience with dispensing medications in expanded access programs, which serve as a bridge for patients who need therapies before they are widely available. The exposure to emerging therapies highlighted the critical role pharmacists play advocating for patient access to life-saving interventions.
Looking ahead
I was fortunate to be part of a team shaping the future of pharmacy. With incredible advancements on the horizon, this rotation has solidified my passion for IDS and inspired me to pursue a career at the forefront of medical advancements. I can’t wait to see the studies I contributed to one day reach the market and impact clinical practice.