We’ve all heard these metrics — 31 percent of Phase 2 and 30 percent of Phase 3 trials are running longer. And site staff members are over-resourced. Time delays demotivate site performance.
There are three pieces to the puzzle to make clinical trials successful, including pharmaceutical/biotechnology companies, patients and sites. Sites are just as much a variable factor as patients. Once sites are demotivated, it takes a three-fold effort to get them back on track. The time gap to get sites re-engaged can significantly impact enrollment activity.
So why not engage sites right out of the gate, or at least recognize when you should pay extra attention to their voices. Site recruitment and retention training is a great way for sponsors to “give back” to sites in the ever-so-competitive landscape, to establish and maintain visibility at the site level. High-yield trainings should be face-to-face and focus specifically on a particular program.
Even in a situation whereby the patients will only come from internal sources, trainings can be successful. Trainings not only can identify external solutions but important, sometimes overlooked internal solutions (i.e., patient identification processes). Case in point: Recruitment training for a chronic lymphocytic leukemia (CLL) study.
This particular study was conducted in North America across 84 sites. Total enrollment was 350 patients to be achieved over a 24-month period. After a year into enrollment, the study had achieved 9 percent of enrollment. Patient identification was a long and tedious process, which eventually started to drain staff resources. It was determined that a renewed focus was needed. Therefore, the client contracted with DAC to conduct a study-specific recruitment training.
The goal of this all-day training was to identify enrollment challenges and to collectively determine solutions. The training identified additional educational materials needed to educate potential families and their caregivers well in advance of study participation, given the limited window of identification. The training also mapped the current identification process among sites. Four months later, the client decided to conduct a second series of trainings based on the significant enrollment impact following the first training. The graph below illustrates the impact in enrollment activity following the first training. The results from the second training mirrored that of the first.
You may have heard the expression, “You must slow down to go faster. Well, that is true when it comes to site motivation. You must slow down and take the time to listen to the sites to ensure their engagement. Once they feel valued, they will remain committed to the study and the desired outcome.
So next time you are challenged with demotivated sites – Stop, Look, Listen and then Act!