How to restart a clinical trials program
The circumstances of a recent pre-study assessment visit were unexpectedly touching, and productive, considering the absence of a Study Coordinator (SC).
The experience altered some unfair perceptions I had regarding individual status and achievement and reminded me that greatness, though a noteworthy goal, unfortunately can change people. And grace is a constant, grounding force that reinforces compassion and unites us.
The Principal Investigator (PI), extensively published and lauded in his specialty, was both courteous and affable, a wonderful conversationalist. He conducted the entire four-hour assessment visit with me in place of his unexpectedly absent SC. He explained the site’s process for research conduct, regulatory documents and timeframes; vividly described patient recruitment practices and provided an extensive facilities tour.
This was highly unique. In my 15-year clinical research career, I have never had an investigator complete an entire assessment visit. I have had conscientious PIs provide an hour or more of their time for a protocol review session. But every visit is attended primarily by an SC or site representative. Because of their hectic clinic or teaching schedules, it can be a challenge for PIs to provide the requisite 20-30 minutes needed to discuss the protocol, enrollment and PI responsibilities. It is unheard of to have a PI present through the entire assessment. However, nothing about this physician was ordinary or predictable. His diligence demonstrated his commitment to our study, devotion to his staff and desire to rebuild the clinical research department of his institution.
Upon arrival at the site, the PI thanked me for coming and asked if I needed assistance setting up my computer for the presentation, connecting it to the projector before I could answer. He asked if four hours were enough to complete our activities. His immediate kindness had me at a loss for words. His demeanor was disarming.
While my inner optimist was jubilant, my inner skeptic was dubious. The assessment would consist either of exaggerated capabilities to solicit a trial or an honest discussion of site capability and commitment to trial success.
Before I started the protocol review, the SC rushed in, apologizing for being late. She said her schedule accidentally had been double booked for procedures, preventing her from completing the visit with me. She had arranged to spend her lunch break attending the review. Her boss (the PI) had rearranged his schedule to conduct the visit. This impressed me, for rather than rescheduling the visit, causing additional cost and inconvenience, or having another staffer attend, the PI had put patient and staff needs above his own. His actions spoke volumes regarding staff treatment and study priority.
Site feasibility paperwork noted the PI had not participated in a clinical trial in five years, which indicated either lack of experience or a hiatus. Neither were positive signs. Before I could ask, the PI clarified this with surprising candor. He said significant budget cuts 10 years earlier essentially had cut the clinical trials program at the institution. His status changed from medical director of clinical research to head of urgent care and emergency medicine and, while grateful to have kept his job, he did not particularly enjoy it. He missed clinical research, the excitement of cutting-edge therapy and the patient education and interaction. He had been trying to revitalize the research effort and, finally, a recent administration change had resulted in funding for clinical studies, in an effort to modernize and grow a tired brand. It was the PI’s responsibility to attract sponsors back to the institution, no easy task.
The skeleton of an established research infrastructure was still present, with SOPs in place and guidelines that still were relevant, critical to an efficient re-establishment process.
During the site tour, I confirmed appropriate equipment and staffing and, more importantly, I gained an understanding of how the staff regarded their leader. In each department we visited, the PI spent a little extra time speaking to staff. From the housekeepers to the clinic staff, he knew every employee’s name and pertinent details about his/her life. In return, each staffer was eager to interact. This was the greatest display of reciprocal kindness and respect I had seen at a site, a true testament to the philosophy of valuing employees to promote institutional success.
At the end of the visit, the PI thanked me for my time and attention, his words pivotal: “Our patients are open to clinical research and the benefits for alternative treatment. I want to give them every chance.” With a smile, he added, “Plus, I am so tired of doing paperwork.”
I recommended this site, not because I felt sympathy for the PI’s plight or I was influenced by his charm. I recommended a gracious, conscientious physician, motivated to find the best treatment for his patients and dedicated to ensuring a positive working environment for his staff. Such integrity assured safe and successful study conduct, which is all I can ask of any PI.
Elizabeth Blair Weeks-Rowe, LVN, CCRA, has spent nearly 14 years in a variety of clinical research roles including CRA, CRA trainer, CRA manager and clinical research writer. Currently she works in relationship development/study startup in the CRO industry. Email firstname.lastname@example.org.
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