Startups Are Bringing a ‘Fresh Perspective’ to Clinical Trials

Organized and promoted by the Association of Clinical Research Professions, Clinical Trials Day is recognized annually on May 20.

Several startups supported by the Polsky Center for Entrepreneurship and Innovation at the University of Chicago are addressing challenges in clinical trials – such as enrollment, workforce development, and patient diversity.

“The clinical phase of drug and medical product research and development is long, expensive, and complex, creating many opportunities for disruption and optimization. I am excited to see a growing number of students, alumni, and serial entrepreneurs pointing their digital solutions towards clinical trials,” said Melissa Byrn, Assistant Dean for Clinical Research at the University of Chicago.

“Entrepreneurs entering the clinical trial space are driven by the opportunity to bring novel treatment options more quickly to market, to match patients more easily to trial opportunities, and to diversify and optimize the data used for FDA approval and clinical decision making,” she added. “It is all about impact and the recognition of how important this phase of the medical product development cycle is. I am thrilled to see entrepreneurs affiliated with Chicago Booth and the Polsky Center focusing on solving key pain points in the clinical trial industry.”

// iTrials

A participant in Cohort 3 of the Polsky Center’s Transform accelerator, iTrials is an AI platform for clinical trial enrollment that automates participant matching and reduces reliance on IT support and recruitment firms.

“Clinical trials are the backbone of medical advancement, essential for validating the safety and efficacy of new treatments. The traditional approach to clinical trials is inefficient and expensive. Innovation in this field is not just desirable; it is imperative to meet the growing demands of modern medicine,” said cofounder Nitender Goyal, MBA ’21.

“AI-driven platforms can analyze vast amounts of data to identify potential participants who meet the specific criteria of a trial,” he said, adding that advanced analytics also can be used to improve retention rates by identifying factors that might lead to patient dropout and addressing them proactively.

The design of clinical trials themselves also is a focus of innovation. Allowing for modifications based on interim results, adaptive trials are becoming more feasible with the help of real-time data analytics.

“Embracing innovation in clinical trials through AI and advanced analytics is crucial. It can result in streamlined processes, reduce costs, and ultimately accelerate the delivery of new therapies to patients in need,” said Goyal. “As the healthcare landscape evolves, so must the methods we use to explore and validate new medical interventions.”

// UpTrials

Focused on innovation in workforce hiring, upskilling, and enablement, UpTrials, recently took first place at the Alumni New Venture Challenge (ANVC) finals, a track of the Polsky Center’s top-ranked New Venture Challenge accelerator program.

“Clinical trials are one of the most important yet often overlooked parts of the research and development ecosystem. Given the number of stakeholders involved and the complexity of the trial process, there is significant room for innovation in clinical operations,” said founder Renuka Agarwal, MBA ’18.

This need for innovation is only going to become greater alongside increasing R&D investment and trial demand, she noted, adding that areas seeing recent innovation include clinical trial design and patient enrollment.

“We’ve also seen the topic of patent diversity in clinical trials finally getting the attention it deserves, and there are many organizations taking grassroots approaches to engaging a wider range of patients in trials,” she said.

// Ark Health

Hoping to help address the challenge of diversity in trials, Ivan Chen, MBA ’26, founded Ark Health, which is a finalist in this year’s Edward L. Kaplan, ’71, New Venture Challenge (NVC). The startup is building an inclusive clinical research platform that allows providers and sponsors to recruit and retain more patients in trials.

“The long-term vision is to improve clinical trial diversity,” said Chen, noting that there are “real legislative tailwinds to support the need for more diverse patients in clinical trials.” Specifically, recent updates will now require diversity action plans and quotas for pivotal trials.

“Pharma is on notice,” said Chen. “We have to take this seriously – this is not another nice to have.” And the regulations are only going to become more stringent. “We need to start with building community, building trust, meeting patients where they are,” he added, noting that there is no “turnkey” solution.

“We need to help people understand the value of clinical trials, understand how they work, and where they fit into treatment options,” Chen continued. Still, while there has been a lack of progress, the people working in this space have remained passionate about improving clinical trials for everyone, he said, speaking to the many conversations he’s had leading up to the NVC finals later this month.

Importantly, everyone is on the same page. “Aligning on a problem – that is a big deal,” said Chen. “There is hope, and we should keep driving forward. Someone is going to find something that works. Let’s go get it.”

The Right Time

Among other work bringing attention to the clinical trial industry is the FDA’s new Center for Clinical Trial Innovation and the ARPA-H Advancing Clinical Trial Readiness initiative. Additionally, CancerX selected several companies for their inaugural Startup Accelerator cohort focused on clinical trial workflows.

“Innovation in clinical trials will require new technology solutions and new ways of conducting and managing trials and this is where startups can bring a lot of value,” said Byrn. “Companies like UpTrials, iTrials, and Ark Health are bringing a fresh perspective to a space that has been historically slow to innovate. These startups are entering the clinical trial space at the right time.”

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