The Investigational Drug Service (IDS) is a licensed pharmacy that provides support and guidance for the safe and efficient conduct of clinical drug trials. During Pharmacy Week, we met with these stellar research pharmacists and technicians working behind the scenes to bring novel treatments to our cancer patients to learn more.
What is the role of an investigational pharmacist and technicians in cancer research?
The investigational pharmacy staff specialize in clinical trial documentation and dispensing trial medications according to the protocol [a detailed plan of a research study]. The dispensing process may vary greatly between protocols even if it is for the same investigational product [drug] making the work extremely detail-oriented. We follow a lot of the same policies and procedures as a regular pharmacist; however, we go above and beyond standard documentation for inventory, temperature control, and chain of custody.
Our investigational pharmacists currently manage investigational products for over 500 protocols (65% are oncology studies). Some of the services investigational pharmacists provide to study teams include the following:
- Assisting with protocol logistics: trial setup, randomization, blinding protection, product storage
- Meeting FDA documentation requirements: drug accountability, temperature logs, chain of custody.
- Creating dispensing procedures compliant with institutional policy as well as federal/state pharmacy regulations
- New for 2021 - Assist in creating and updating electronic ordering infrastructure in Epic [electronic health record system]
How has COVID impacted the dispensing of investigational drugs? How has the new COVID policy of shipping drugs directly to patients impacted the IDS?
Stanford Health Care IDS has not shipped study medications during the pandemic, so we did not have a big change from that perspective. Sponsors shipping drugs directly to patients during the pandemic helped immunocompromised patients as they did not have to travel to the clinic during the height of the pandemic. Our biggest change during the pandemic was switching study monitor visits from onsite to remote. We continue to offer only remote visits for study monitoring.
What is the most rewarding part of your job?
The work is very challenging and mentally stimulating. Having detailed access to read about the latest medical advancements. IDS receives clinical trials from any disease state so we get to work with a wide variety of topics from oncology to transplant to hepatology to dermatology. In addition, the amount of accuracy and consistency required to dispense on a clinical protocol creates many opportunities for process improvement. We enjoy working with our team to create a safer dispensing process. Additionally, the pharmacy staff enjoys being a part of the study team to bring hope to patients when often a therapy in a clinical trial may be the last hope. Seeing patients respond well in a trial validates what we do every day; it makes us smile.
What does the team like to do in their free time?
Many of our staff enjoy spending time outdoors (eg, fishing, hiking, camping) with family, friends, and pets. We also all enjoy food and exposing each other to new experiences.
