Site Crunch Challenges Made Worse by Pandemic, Eased with Sponsor Engagement
Sites are being asked to do more with less as revenues and resources decrease at the same time sponsor demands for COVID-related trials increase. But altering the dynamics between sites and sponsors may be part of the solution.
Signs of site crunch can vary by site, but there are some common indicators, says Molly Hair, director of site engagement and management at WCG ThreeWire. If you are looking at a data backlog and the possibility of not meeting the deadline for database lock; if you don’t have the time to give participants as much attention during the trial as you did during recruitment; if you can’t effectively execute your recruitment plan, “then you probably need help,” she says.
Sites shouldn’t be reluctant to accept resources sponsors offer for fear of looking weak or ineffective, she adds. “If the sponsor is offering, that’s a sign that the sponsor values you and wants you to succeed.”
Other site crunch issues, such as the availability of principal investigators (PIs), have been made worse by the pandemic, says Seth Nelson, vice president for clinical strategic solutions and new product development at WCG ThreeWire.
“The number of trials and the complexities are continuously increasing, yet there are fewer sites and PIs participating to meet that need. Until those trends move in the other direction — when we figure out the best way to meet that need and create more PIs and more sites — there has to be more efficiency and collaboration” across the industry, Nelson says.
And patients, nervous about their treatment options, also add external pressure to sites. “Patients are getting a lot of information from a lot of different sources,” he says. “When they look at a clinical trial, you become the source of education as you try to steer them to make the correct decision and get the care they need.”
“The world is full of surprises right now, and they’re impacting us not only emotionally, but also the policies and processes that we have at our sites,” Hair says. “At a time when we’re feeling extremely volatile, we have to take a step back and we have to see what we can actually control.”
Hair recommends sites perform a “brutally honest” assessment of their capabilities, including determining what percentage of their studies met or exceeded their committed enrollment contribution, how many enrolled patients completed all their study visits and whether studies experienced a data entry backlog or missed data lock targets altogether.
When dealing with staffing shortages, look for redundancy in your organization, she adds. Shift staff from one department to another or from one trial to another. For instance, if you are ahead in your oncology trials’ data entry but falling behind in another therapeutic area, transfer that staff to provide support for the lagging trial. And if you’ve furloughed employees, think about how you can reassign them.
If sites are not already creating recruitment plans for every study, Hair advises, they should start setting specific recruitment goals, targets and metrics to improve performance evaluation. Sites should also create a resource assessment for every study and determine whether their study teams receive enough uninterrupted work time to focus on trial management responsibilities.
“Allowing for your teams to take advantage of uninterrupted time is pivotal. We have to love our professional selves more by giving ourselves and our colleagues that time to work in an uninterrupted fashion, and if we do so, things are just more efficient and the quality of work can be better.”
Sites also should reach out to other sites to grow their databases, Hair says, and determine if they can broaden their portfolios by moving into new treatment areas.
“We really need to take a look at what we do to be better and smarter. In this point of crisis, there’s this huge opportunity to do something positive. It’s a time for reinvention.” Hair says sites should brainstorm internally for solutions to address limited resources while also communicating with sponsors, vendors and other sites. “We are in a world where we cannot be siloed any longer.”
“Now is the time to say, ‘why have we always done x, y or z this way and how can we do x, y or z differently now.’ How can we be flexible in our thought process so that we can come up with new ideas about how to address all of our concerns,” Hair says.
And when sites come up with new ideas, she adds, they should share them with sponsors. “When you have ideas to make your life easier … share it with them,” she advises. “Let the sponsors support you.”
When asked how to respond to a sponsor who makes unreasonable demands, Nelson says sites should be upfront and realize the amount of leverage they have in negotiations.
“Flat out ask for what you need to be successful [to do] what they’re asking for,” he says. “They’re not going to want to lose you. [Sponsors] have that one trick in their bag where they’re always going to be asking for more. They don’t have as many sites and PIs to go to, so the ones that are successful are going to get their eye.”
Hair concurs, adding that sites have the right to set expectations and set the tone for any conversation. “They may try to call your bluff a little bit when you ask for things, but the reality is ... they put a huge amount of financial investment into the site selection process. They have selected you because you are good, because you are valuable.”
“You are actually bringing something extremely valuable to the table — the good work that you and your site have done, your database of cultivated patients, your expertise,” Hair says. “This is of value to the sponsors, so when you go into those conversations, know that you’re on more equal footing than what you feel like you are.”