The study is behind schedule. Enrollment is lagging. The protocol is too complicated. Approximately 80 percent of all clinical studies need intervention or optimization to be successful, but only about 10 percent get it. Why? Because there is an negative connotation to the term “trial rescue.” Some Sponsors don’t want to admit their clinical trial needs assistance — and some contract research organizations (CROs) don’t want to request help.
In reality, receiving clinical trial assistance as soon as trouble rears its head is the best way to save time, resources, and cost. At Biorasi, we are experts at trial rescues — working with Sponsors and CROs to help identify and correct the inefficiencies or issues that are keeping the clinical trial from reaching its full potential.
Trial rescues are common, important, and transformative. Here are the top four reasons Sponsors need help to ensure their clinical trial is as productive as possible.
Ineffective planning is the number one reason why a clinical trial can get off course. Maybe stakeholders disrupt the planning process. Perhaps there are enrollment problems that could have been foreseen and avoided if the planning had been more rigorous. Whatever issues arise, we leverage a diagnostic root cause gap analysis to shed light on holes in the planning — and find the best ways to mitigate future issues. Project management is critical to any clinical trial; making sure everything is managed against a solid plan provides the best chance for staying on track.
No clinical trial is perfect and no two clinical trials are the same, which is why there is always the potential for something to go wrong. Our team plans for any and every risk to ensure that the safety nets are in place when and where they should be so that the trial stays on track. Let’s say a Sponsor is rejecting site after site because each lacks one out of 10 criteria needed for the study. Our team might recommend that instead of spending more time and resources looking for “the perfect sites,” the Sponsor fix those criteria so the sites can participate. By doing what we can to logistically plan for the trial, we can help the Sponsor keep up with timelines and milestones.
Enrollment issues can delay the clinical trial, create a longer timeline, and increase cost. According to a national opinion poll, 72 percent of people are willing to participate in a clinical trial if they are asked. So how do Sponsors reach them? The answer may not always be more sites: adding study sites doesn’t linearly increase recruitment rates. Having relationships with many organizations and clinics is one component to finding patients, but it’s also about selecting the right sites. It is important to match sites to patients. Biorasi has global affiliations that enable swift ramp up and access to various patient populations.
Reason: Unnecessary Protocol Complexities
Increased protocol complexity inflates clinical trial time and expense. By leveraging the gap analysis tool, our team can review the protocol to see if there are ways to improve the design of the study. If we discover opportunities to do so, our study design and statistics group works with the Sponsor to realize those changes. While the study protocol is second nature to the Sponsor, working with a third party can often uncover design enhancements or modifications that were initially missed.
Reason: Circumstances Beyond Your Control
Many outside influences — regulatory or manufacturing issues — can affect a clinical trial. Things can go wrong with formulations; patients can decide not to comply. There are always challenges and, while it’s impossible to design a foolproof protocol, bringing in the right team that can come up with solutions effectively is key to moving past the issue.
Sponsors rely on Biorasi for trial rescues because our team is swift, agile, flexible, and solution-driven. We can provide an optimization road map for the Sponsor to use or work side by side with the incumbent CRO to deliver results. And in the event the Sponsor asks us to take over the study, we are sensitive to the transition.
To learn more about Biorasi’s expertise in trial rescues click here.