In a throwback to a podcast with Joseph Kim, Chief Strategy Officer at ProofPilot, Brad Hightower, the CEO of Hightower Clinical, shared some candid criticism of the ongoing issues that hinder progress in the clinical trial space.
“Who's the drug really for?” Thoughts on restrictive eligibility criteria
One notable challenge Brad emphasized is the restrictive eligibility criteria prevalent in many studies. While these stringent criteria aim to recruit the most suitable participants, they often fail to capture the diversity found in real-world populations.
Brad: “Oftentimes, these are phase three trials. These drugs that get approval, who are they prescribing them to? Are they only prescribing them to those tight, narrow criteria patients? Well, no, they're not, they're prescribing them to a much broader patient population. So my take is like, well, then why aren't we testing it on the broader patient population? Why aren't we testing on what real patients look like?”
Brad advocates for broader eligibility criteria to ensure that trial data more accurately represents the target population. This approach would ultimately benefit the end-users, who won't be excluded from treatments due to factors like a high BMI. Brad even suggests that opening up eligibility criteria could have a beneficial impact on enrollment.
Sites, beware of catfishing! Quiet quitting is real
Brad also discussed issues related to protocol expectations. Frequently, the full protocol is not disclosed until both parties are deeply involved in the start-up phase. As a result, sites often end up opting into a trial that on first appearance seemed to fit with their patient population, resources, and capabilities, when in fact the trial requires much more complex, frequent, and time-consuming procedures. This also negatively affects the patient experience.
Brad: “it’s [also] what we're asking the patient to deal with by being in the trial.”
Brad suggests that a cohesive, integrated workflow inclusive of essential central and vendor processes and technology could streamline trial conduct. This would not only simplify conduct for sites, but also enhance study recruitment. When studies are unexpectedly complex, sites will quiet quit by funneling patients to easier studies.
Am I conducting a trial? Or participating in a scavenger hunt?
The process of following a protocol and searching for clarity can quickly become overwhelming. What initially seems straightforward, like taking vital signs, can turn out to be much more complex.
Brad: “The protocol doesn't always tell the whole story, even in and of itself. So I can look at a schedule of assessments and see that I need to draw vital signs. Well, what I didn't know is I needed to do them three times, 5 minutes apart in different postural situations, and those sorts of things start to stack.”
The current procedure manuals, if provided at all, are convoluted, fragmented, incomplete, and even contradictory. Compounding the issue, there's often a separate instruction manual or training deck for each vendor-provided system, exacerbating confusion.
Brad highlighted the urgent need for clear, simply laid out, and user-friendly workflows for site staff. However, only about 10% of sponsors provide such guidance, with smaller companies often outperforming larger ones in this regard. Brad argued that improved guidance would streamline study conduct, expedite patient visits, reduce errors, and enhance data quality, ultimately benefiting all stakeholders involved.
Can't get enough of Brand’s no-nonsense style? Listen to the full conversation here.