Basic staff competency and adequate facilities are a given at most clinical trial sites, which is why the all-important “human factor” shouldn’t be overlooked—especially during a visit from a potential sponsor to gauge the feasibility of a site for inclusion in an upcoming trial, says Elizabeth Weeks-Rowe, LVN, CCRA, who works on site selection and education in the contract research organization industry. She brings 21 years of clinical research experience to the topic, including work as clinical research coordinator (CRC), clinical research associate (CRA), and CRA trainer/manager.
Weeks-Rowe, who has been a certified CRA (CCRA) through ACRP since 2004, thinks most sites do a pretty good job presenting themselves. However, “soft skills still aren’t being recognized for how important they are” when it comes to separating a site from the competitive pack, she notes.
“The slightest tweak” in attitude, preparation, and presentation “can make a big difference” when a sponsor is mulling whether to engage a site, Weeks-Rowe says.
On the other side of the equation, sponsors need to gain an understanding from the visit of “what your site can do to support reaching the endpoints in their study,” Weeks-Rowe notes.
Part of the requisite sponsor due diligence is sizing up how site staff handle the sponsor visit. At small sites, it’s effective to have a single person handle it if they are prepped on areas outsider their expertise. For example, a study nurse might need to get some input from a pharmacist on the team to understand issues like transporting and storing drugs, Weeks-Rowe says.
At larger sites, she suggests a two- or three-person team from across the spectrum of trial activities represent the site when the sponsor comes around to kick the tires. It’s not going impress a potential sponsor partner if your site team can’t answer questions or get answers readily, Weeks-Rowe adds.
Meanwhile, don’t forget presentation skills, she cautions. “You don’t have to be a game show host, but a site needs to show enthusiasm for the study” in addition to showing its wares and overall practical capabilities, Weeks-Rowe says.
For example, she’s seen times where a site representative shows impatience with a sponsor. “They’ll act annoyed and say, ‘you already asked me that question,’” Weeks-Rowe notes. Accurate or not, it won’t endear the site to the sponsor, she adds.
Finally, sites should never forget to prep others who might encounter the sponsor visit team. Weeks-Rowe recalls working with a CRC who was clearly embarrassed by the bad attitude a pharmacist displayed during a sponsor visit. “The pharmacist obviously didn’t want the study and kept wondering out loud if they had enough storage space” for it in front of the sponsor, Weeks-Rowe recalls. It took a lot of post-visit work for the CRC and site team to convince the sponsor they were in fact worthy of the trial assignment.
Author: Michael Causey