Cancer translational research has produced many new and effective medicines for patients with cancer and, as a result, the number of clinical trials continues to increase. Patients seek the best available medicines for their cancer, and sites with investigators and administrators who make opening a new clinical trial rapid and straightforward typically get access to those new drugs faster.
But what makes one facility preferred over another? It’s not just about the patient population. Stephen Gately, PhD, Chief Executive Officer of TD2, explains:
What are the biggest challenges sites are facing right now?
For many sites, there is a surplus of possible clinical trials, rather than a shortage of them: Often, sites are inundated with new trial opportunities every day. But with those opportunities comes incredible operational strain on the staff as they try to keep up with feasibility requests, start-up processes, enrollment goals and close-out demands—all while continuing to focus on excellent patient care.
How can sites ease that operational strain associated with running a clinical trial?
It comes down to finding new ways to unlock efficiencies and streamline. Having a standardized, repeatable process for trial activation can bypass much of the unnecessary administrative work that bogs down operations. That said, sites shouldn’t be so locked into the process that they become inflexible and can’t respond to inevitable changes.
Equally important is communication—namely, keeping everyone in the loop with updates, needs and progress. That means all stakeholders: legal, regulatory, finance, data entry, lab staff and clinicians. They all have a role to play, and deserve a direct line into the communication loop. Streamlining that process throughout the trial’s duration can help ease some of the operational burden. It’s also a major differentiator during site selection.
Which technologies give sites a leg up?
Currently there is a tremendous push to innovate the way patient data is analyzed and used. We’ve seen an abundance of new technologies, including AI, that hold promise for this—but even still, data curation requires a great deal of human involvement. The lift to keep data clean, current and uncompromised is a heavy one, so sites that engage tech in a way that streamlines that process will certainly have a competitive advantage.
How can a well-selected site boost trial enrollment?
Targeted cancer treatments demonstrate dramatic clinical benefits if a patient’s cancer has specific genomic or other contexts of sensitivity. This means that sponsors have to design protocols around well-crafted inclusion and exclusion criteria to ensure those patients can participate. Sites that have processes to identify highly refined patients will ensure higher patient clinical benefit as well as access to emerging targeted therapies.
Real-time patient data is the secret ingredient: Insights, like those we provide TD2 clients, can help sponsors select sites that have eligible patients (or patients that will be eligible in the future).
What mistakes do some sponsors make related to site selection?
I often see sponsors choose sites that have a strong performance record or rapport that doesn’t necessarily translate to their present needs. For example, a site that worked well for a previous project may not have the capacity or patients necessary for the next one.
Sponsors should also be careful not to set unrealistic expectations for trial milestones—such as first patient dosed, enrollment rates or trial close-out. When sites fail to deliver, they become immediately and unfairly viewed as underperforming—and that holds everyone back.
Another mistake is not treating the site as a partner critical to achieving successful outcomes. Think about it: Clinicians at sites have one of the most important jobs in clinical research. They must understand the science, identify the right patient based on that science—and then convey that science in a way a patient will understand. Imposing impossible demands on them is a grave mistake, one that can create a serious misalignment between sponsors, CROs and sites.
How early in the research process should sites become involved?
At TD2, we tend to be attracted to sites and investigators who want to be involved in the development of the clinical plan at the onset. As drugs approach their first-in-human trial debut, there is huge benefit in early engagement among all parties. Naturally, an investigator who is passionate about the program makes for a more seamless start to a successful partnership between the sponsor, site and CRO.
From a health system perspective, there is incredible benefit in getting more engaged with the research industry to get access to the best available medicines for patients. Patients are smart. They actively search for ways to treat their disease and will seek out sites with access to the best new medicines reporting benefit in others like them. Effective and efficient site processes attract motivated patients with diverse cancers. This is the perfect ecosystem to place your important new medicine.
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