Being realistic, responsive and transparent is key in engaging unresponsive and underperforming clinical trial sites; that was the takeaway from the opening keynote session at the ongoing Outsourcing in Clinical Trials West Coast 2025 conference.
Leesa Gentry, Chief Clinical Officer for the San Jose, California-based RenovoRx, said that given how sites can be overloaded, it is a sponsor’s responsibility to keep them engaged, and to ask what they can be doing better. “It’s really easy to blame sites, but it’s not fair to blame them for all the issues we have in clinical trials,” said Gentry, who oversees clinical operations at the biotech, which is developing targeted cancer treatments.
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It is common knowledge in the sector that many trials are terminated due to low accrual. At a time when companies are unsure of how many studies they will be able to conduct due to financial constraints, it is vital for them to better engage staff and patients to ensure that recruitment challenges are not an issue.
Staffing at trial sites has reduced since Covid-19
A huge contributing factor to why sites are not always fully engaged with sponsors is that they have reduced staffing. Since the Covid-19 pandemic, the number of individuals working for sites has reduced, adding more burden to each investigator.
“Site staff burnout and understaffing is rampant. Staff have very little time and very little support, [and] we are giving them a protocol that’s three times more complex than it was five years ago. What’s the reason for that?” Gentry questioned. “It’s mainly because our resources are also constrained, and we have to throw everything into that protocol to make sure that we’re answering all the questions we can with one study, because who knows if we’re going to get to do another one.”
Sponsors are trying to balance getting as much as possible from a trial while keeping the workload manageable for site staff. Answering more questions also means that sites are being burdened with more technology and data points and while these technologies can be helpful, they need to be used efficiently, says Gentry. “We need to use it in a way that makes sense,” Gentry adds.
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By GlobalDataWhat is the solution?
With stakeholders prioritising their diverse interests, it can be difficult to work out the ideal solution should, but the most vital step, according to Gentry, is to be “realistic, responsive and transparent”.
“Get all the right people on the phone if there needs to be a discussion – be responsive, make sure that you are responding to sites faster than they are responding to you because they will match your energy,” Gentry adds.
If sponsors engage better with sites, they will better engage with sponsors who will become the “sponsor of choice” for site staff, which makes for an easier study for all participants.
Being realistic is also a vital step in the process – sites may exaggerate how many patients they can enrol in a study and by the time eligibility and consent are considered, this number could be far lower than originally predicted – it is therefore necessary for sponsors to consider this potential hurdle from the outset. Additionally, while everyone is working with more strained resources, budgets need to be within reason for sites to effectively and efficiently conduct a sponsor’s study.
Nonetheless, it is also important to consider that these solutions may not always be effective, Gentry added.
“There are some sites that are not going to enrol and are not going to perform. Some sites will remain difficult to work with— all of that is true. Sponsors can help by over-enrolling sites. Help sites understand why you are not choosing them for a particular study. Think global but act local. Having that 30,000-foot view makes things easy and efficient across your study but be willing to dive in with sites and help them find a process that works… Finally, ensure you are getting site and patient feedback protocols,” Gentry concluded.
