The integration of emerging digital technologies across the entire clinical trial lifecycle has been a transformative force in modern medical research in recent years, especially in the U.S.

Cutting-edge tools are enhancing efficiency, accessibility, and data quality in clinical trials — innovation that has been sorely needed in healthcare to expedite the launch of life-saving medicines and therapeutics.

In the past decade, advancements with decentralized clinical trial designs, real-time data collection and consolidation, AI-driven analytics, and wearable health monitors have reshaped traditional clinical research methodologies.

Startups are certainly driving some of this innovation.

However, building without relationships with life sciences incumbents can prevent startups from effectively exploring, testing, and validating solutions related to major issues facing the industry today, particularly those in clinical trials.

Big life sciences industry players are best positioned to guide the development of new solutions that deliver business benefits, speed up medical progress, and improve outcomes for patients.

Where the Clinical Trial Innovation Opportunities Are for Life Sciences Organizations Today

By leaning on their R&D and innovation teams (and embracing open innovation with partners in, adjacent to, and completely outside the industry), life sciences firms can develop solutions that can drastically enhance trial efficacy and expedite trial completion through rigorous design, execution, and data analysis.

Some notable innovation opportunity areas we’ve identified, based on industry conversations, include:

Rethinking Traditional Clinical Trial Recruitment

Inarguably one of the biggest barriers to quick and efficient clinical trial execution is candidate recruitment.

Incremental improvements to how contract research organizations (CROs) conduct trials, including participant-sourcing methods, have led to drastic decreases in trial-completion and drug-approval timelines.

Still, 80% of delays in clinical trial timelines remain tied to patient recruitment and retention issues.

"The integration of AI and advanced analytics really promises to do everything, from enhanced trial design to optimizing recruitment and also improving data analysis," Molly Cross explained in a recent healthcare-focused Advantaged episode.

I echoed Molly’s sentiments on the episode. Despite the potential for less federal regulation demanding more diverse clinical trial pools, many trial sponsors are likely to continue to push for diverse inclusion "because they want their drugs to be proven to be effective for the broadest swath of the population."

That said, challenges remain for trial sponsors to ensure they consistently have clinical heterogeneity. Assessing their current recruiting approach can help them pinpoint the problem(s) likely causing low or insufficient clinical trial enrollment and diversity.

Through such an evaluation, they may discover they have:

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• Overly stringent inclusion/exclusion requirements
• Poor external messaging around trial objectives
• A high level of trial complexity confusing participants
• Geographical, cultural, and language barriers preventing candidate inclusion

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Thankfully, some strides have been made on the technology front related to clinical trial recruitment.

Consider Johnson & Johnson (J&J). The multinational pharmaceutical and biotechnology corporation partnered with Trial Library to integrate the company’s clinical trial discovery solution into J&J’s oncology clinical development and medical affairs programs.

The goal is to boost trial diversity (specifically, to get more people from marginalized groups to participate.)

Embracing Decentralized/Hybrid Clinical Trials

One factor that can improve a critical component of clinical trials — diversity — is the decentralized trial model.

As I shared on Advantaged, this model can ensure more diverse participation — something that is good for the industry and individuals because it increases the ability to engage people that usually don’t participate in trials.

In late 2024, the Food and Drug Administration issued guidance to support decentralized clinical trials for drugs, biological products, and devices.

This allowed for "some or all trial-related activities to occur at locations other than traditional clinical trial sites" and the use of digital health technologies (DHTs) to collect data from patients via telehealth appointments.

Through a decentralized approach, medical researchers can ensure individuals who reside in remote or rural areas and/or lack sufficient transportation to attend in-person trials (ones they'd otherwise have to travel several miles to take part in) can participate, in turn improving the representation of the studies' population.

COVID-19 also catalyzed adoption of hybrid trials, which combine remote monitoring with periodic site visits. Hybrid models have also been shown to boost rural trial enrollment while maintaining data integrity levels comparable to traditional trials.

"Expanded inclusivity and accessibility promote greater insights regarding how treatments work across varying demographics and ensure that novel therapies are effective for the entire population," Girardin Jean-Louis, Ph.D., of the Miller School of Medicine at the University of Miami, wrote in a recent paper.

Despite increased adoption of decentralized and hybrid trials nationwide, these approaches still come with challenges that prevent efficient and effective implementation by life sciences organizations:

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• Complex regulatory jurisdictions. Navigating the numerous international regulations for multinational clinical trials remains a major barrier for execution.

• Adapting legacy regulations. Existing frameworks for traditional clinical trials often conflict with decentralized components, which necessitate extensive updates.

• Global data protection compliance. Adhering to GDPR and HIPAA while managing cross-border data flows has proven tricky for healthcare organizations.

• Tech accessibility gaps. Socioeconomic disparities limit access to certain medical devices and stable internet connections for some populations.

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Recent research from the Partnership for Advancing Clinical Trials (PACT) consortium shows promising results.

A 2024 PACT report, based on a sample size of 60 decentralized clinical trials, found "actual timelines beat planned timelines from first site activated to first patient enrolled and from first patient to last patient enrolled."

Now, it’s on life sciences firms to test the decentralized model and determine what solutions are needed to facilitate seamless trial onboarding, execution, and analysis — an assessment that could reveal opportunities for tech development in-house or with innovation partners, such as a consortium like PACT.

Innovating Beyond Process Improvements to Drive Meaningful Change with Clinical Trials

Despite advancements in these opportunity areas, among others, more innovation is needed to streamline clinical trials to further accelerate time to market and get treatments to patients faster.

“The increasing complexity of clinical trials has created a perfect storm of challenges for clinical research sites, posing significant risks to the efficiency, effectiveness, and sustainability of clinical trials at large,” WCG’s “2O24 Clinical Research Site Challenges Report” noted.

There are certainly countless other opportunities for innovation in clinical trials beyond the two examples above that can lead to much-needed disruption in the space. These include finding ways to:

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• Leverage the blockchain for data integrity (e.g., ensure tamper-proof records)
• Use gamified trial apps that incorporate behavioral economics principles to boost adherence rates
• Use AI/ML models to monitor data and identify real-time inconsistencies/issues
• Employ AI/ML to more accurately predict patient outcomes/optimize trial protocols

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Instead of waiting on startups or other incumbents in life sciences to take charge and innovate around these respective areas, we’re finding many in the space are eager to build their own startups to solve these problems.

The goal of venture building — particularly in healthcare and life sciences — isn't to create yet another point solution that industry players will have to somehow incorporate into their already-complex tech stacks.

Rather, it's about being thoughtful and intentional in addressing issues with purpose-built tech and ensuring interoperability and ease of use for trial sponsors, CROs, and other trial partners.

At Alloy Partners, we believe that life sciences companies are uniquely positioned to lead venture-building initiatives that address a range of clinical trial challenges — not as distant observers, but as active participants with firsthand experience.

By combining startup agility with industry insider knowledge, venture building can be a powerful tool for reimagining clinical trials from within, accelerating medical breakthroughs, and creating new value streams all while addressing the industry's most pressing challenges.

If you’re interested in being a part of the work we’re doing in the healthcare and life sciences space or simply want to continue this discussion with me and our team, don’t hesitate to reach out.