Catching Up With Jill Pellegrino, Now Leading AutoCruitment

By Deborah Borfitz 

October 10, 2024 | For as long as most people can remember, patient enrollment into clinical trials has been abysmal—so much so that 80% of studies don’t finish on time and 55% end due to low accrual rates. The underlying issue is overreliance on study sites to find participants on their own, according to Jill Pellegrino, CEO of AutoCruitment. 

Her name may sound familiar. Up until 2023, Pelligrino was vice president of recruitment and real-world evidence for the now-shuttered clinical trial business of CVS Health. Now, as then, she is focused on the chronic trial recruitment problem using data and national reach to connect people to studies that might be right for them. 

In the case of AutoCruitment, the means is a multifaceted screening methodology aimed at the estimated 90% of the population who don’t get the opportunity to participate in research because their physician doesn’t. Its platform also tackles the challenge of ensuring they qualify for a study based on the often “very narrow” inclusion/exclusion criteria, she says. 

For this reason, the prescreening regimen embraced by AutoCruitment has two extra layers beyond the self-reporting patients do online to initiate the process. That first step typically entails answering a series of questions about their health and medical history.  

While online prescreening for clinical trials is helpful, it is also extremely limiting because patients can’t always accurately recount all the pertinent details, such as the correct name and dosage of the medications they’re taking, Pellegrino says. Patients in respiratory studies might also think of an asthma attack as any time they reached for their inhaler at the gym whereas the protocol defines it as an exacerbation requiring emergency treatment at a hospital.   

The shortcomings of self-reporting are especially evident when looking at more complex disease states, she continues. This is where the other prescreening components come in, one offering a follow-up phone screening with clinically trained staff to review patients’ medical history to ensure they qualify and the other—introduced earlier this year—asking for patients’ permission to get access to their electronic medical record (EMR) through a health information exchange so the data can be summarized, with the aid of artificial intelligence (AI), for recruiting study sites. 

“We’re relying on a combination of factors to get as qualified a patient as possible, and that has been one of the keys to our success,” Pellegrino says. “Not only are we able to find patients; we are able to do it in a way that makes it easy for the sites because those patients are highly qualified.” 

Doubling the Numbers

Many clinical research sites are “overworked, under-resourced, and working on a lot of competing trials,” resulting in poor recruitment performance, says Pellegrino. More importantly, a sizable proportion of would-be participants doesn’t have access to studies through their doctor—available data suggest somewhere between 3% and 10% of practicing physicians are actively involved in clinical research. 

AutoCruitment is targeting that untapped majority as well as supporting the already-overburdened study sites with its prescreening strategies to “substantially increase” clinical trial randomization, she points out. Across the board, the company’s approach nearly doubles the average number of patients enrolled monthly by study sites, trimming on average nine months off enrollment timelines. 

A good example of this is a cardiovascular study involving two populations—people at risk of cardiovascular events as well as those with active disease—where the study sponsor was seeing a significant slowdown in enrolling the latter group. By the time AutoCruitment was called in, the trial’s 112 geographically dispersed sites were enrolling about 25 patients per month. 

A patient-facing digital advertising campaign found 47,000 people with cardiovascular disease who expressed an interest in participating in the study. When those patients were called to go over their medical history, that number was reduced to 10,000 who were thought to fit the protocol.  

AutoCruitment then handed those prescreened individuals over to the sites while serving as a support arm for them to make sure patients were seen and that they stayed engaged throughout the process. “Patients have a lot of questions, and they don’t always hear from the sites as quickly as they would like,” Pellegrino says. 

Ultimately, 4,000 patients were brought in for formal evaluation and testing. Of these, 618 patients were randomized into the study, which equated to an average of 53 patients monthly per site. “On their own, it would have taken them an additional two years to find those remaining 618 patients,” says Pellegrino.  

Easing Burdens

The clinical trials industry is awash with recruitment companies, most of them doing online prescreening and a few of them follow-up screening as well, Pellegrino says. But AutoCruitment is believed to be the first to offer “EMR capture and intelligence,” the service launched in April.  

AutoCruitment has done well over the past decade recruiting patients for studies spanning 120 therapeutic conditions (e.g., central nervous system, pediatrics, gastrointestinal, cardiovascular, vaccines, immunology, and dermatology) without the benefit of this enhancement, which is enabling the company to extend its prescreening services to some of the harder studies that might include those enrolling less prevalent disease populations, she says. So far, the EMR review piece has been deployed for studies of treatments for endometriosis, major depressive disorder, and migraines. 

When asked, about 90% of patients have been willing to give AutoCruitment permission to obtain and review their EMR to see if they qualify for a clinical trial, reports Pellegrino. People’s willingness to grant that authorization was one of the initial proof points for gauging the effectiveness of the new service. 

Many companies are in the business of retrieving patients’ medical records, but most of them rely on people’s memory of details such as the physicians they’ve seen or who gave them a particular diagnosis and the date of their last appointment, Pellegrino says. “We don’t require any of that; we’re just able to get patients’ records through an information exchange, in most states” 

The tactic is fast and entirely integrated into the recruitment portal used by both patients and sites, she continues. Sites can review the EMR summaries right on the platform, and the information is easy to query and search. 

That ease of EMR review and navigation differentiates the service from the AI-powered EMR reviews offered by other companies, notes Pellegrino, all of them relying on sites to provide access to patients. “They’re more solutions to help doctors mine their own EMR,” while “we’re getting authorization directly from the patients themselves” to utilize a breadth of medical records data. 

Leveraging AI

AutoCruitment was founded in 2013 and was initially focused on neurology research, Pellegrino says. It was one of the first companies to adopt digital advertising for patient recruitment and it so impressively grew the customer base that it was acquired in 2022 by QHP Capital, a private equity firm that invests exclusively in healthcare and life sciences, to accelerate its expansion even further.   

Pellegrino says she was introduced to AutoCruitment by QHP Capital, which brought her in as CEO in early 2024 due to her extensive experience in the space and in growing businesses. “I was really impressed with how much [AutoCruitment] had grown and how effective it was at patient recruitment.” 

In addition to its broad therapeutic expertise, the company is a standout in a crowded field in terms of its global capabilities that extend to 37 countries—Germany, Spain, Czech Republic, Poland, and Italy among them, she says. AutoCruitment also emphasizes the use of data and technology across all its operations, to be as efficient and effective as possible at finding patients for trials. 

To that end, AutoCruitment is actively investigating new ways to incorporate AI, most immediately in the development of the upfront advertising it does across multiple channels. Given the sizeable populations it is engaging for trials, randomization results could be further strengthened by better targeting messages, and their audio and visual elements, to specific audiences, says Pellegrino. Testing is already underway where AI is being leveraged in the creation of videos and the generation of content for digital ads. 

The chief challenge in using AI in the clinical trials space in any capacity is that the industry is heavily regulated, she adds. AutoCruitment has therefore been working closely with its partner institutional review board on practical ways to take advantage of AI “within the guardrails.”  

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