SIVs are Still Tedious, Unengaging and Flawed; Sites Share Pointers to Make Them Better
Sites spoke out last week about improvements they need to see in the site initiation visit (SIV), which remains a time-consuming experience for many of them.
One point of contention for sites is that CRAs often show up without a strong understanding of the trial protocol. It’s frustrating and happens frequently, according to Melissa McLennon, monitoring and compliance officer for Memorial Healthcare System. A CRA who doesn’t have a firm grasp of the protocol’s ins and outs will be limited in the questions from site staff that they can adequately answer, as McLennon has seen.
“Many CRAs come to our sites for SIVs and it’s clear they’ve had very little training on the protocol. When our team asks questions, the response is often ‘let me get back to you on that,’ and then they have no trust in that CRA and they don’t want to turn to them for questions,” she said during the Florence Innovation Summit’s SIV session, which drew the most attendees during the event.
It’s a bad way to start a trial and potentially the CRA’s first introduction to the site and can lead to many problems down the line. The sponsor/CRO needs to send a CRA who understands the protocol enough that they can answer nearly every question. However, in some cases, a CRA might have only a few days between being given a protocol and having to present it, Nagzah Ali, business development operations associate at Florence Healthcare, noted.
Kathryn Little, a project manager at the University of Pittsburgh Medical Center Magee Women’s Hospital, wants to see CRAs who tailor the SIV to the site receiving it. A new site that isn’t experienced in clinical research would obviously require more in-depth training, but veteran sites that run huge amounts of trials every year shouldn’t be forced to sit through lengthy presentations on things they know.
For these study-experienced teams, the SIV should focus on the specifics of the study — the unique aspects of the protocol and whatever quirks may exist — with less time spent going into the little details experienced sites already know, Little says.
Sally Pratt, a seasoned CRA with Zoll Medical Corp., believes that remote SIVs are a great way to capture and hold the attention of sites “rather than being in this awkward, tiny room or running around after the doctors while they’re doing other things.”
Rachel Brew, pharma research regulatory coordinator for SCL Health, suggests assigning a research admin who looks at SIV agendas and schedules only the people who need to attend in specific timeframes.
For example, Brew said research admins can schedule principal investigators (PIs) and sub-investigators during lunch hour breaks because they are so busy seeing patients. The research admin is “worth her weight in gold” thanks to the time she saves the site, with SIVs rarely going over two and a half hours and staff, including PIs and pharmacists, knowing exactly when they need to show up.
But frustration about these issues remain and not everyone agrees with Pratt. Spencer Phelps, a research associate/operations lead at St. Peter’s Health Partners, when asked if he’d ever been part of a successful remote SIV, his answer was a resounding no; the only decent times, he said, were with sponsors with whom they had already developed relationships.
“It’s usually a 167-slide deck reading session. It’s terrible,” he said.