Breaking down the latest trends in clinical trials

Clinical trials are a crucial testing ground for prospective drugs and devices. They're also expensive, administratively complex, and enormously time-consuming.

With the rise of new technologies and the changing healthcare landscape, the way life science companies conduct clinical trials is rapidly evolving. These developments - from the use of artificial intelligence to the entry of retailers into the space - could help address the biggest challenges facing clinical studies.

In this blog, we'll explore some of the latest trends in clinical trials and consider how these developments could make studies cheaper, faster, and better - and shape clinical testing into the future.

Advances in technology

Most drug trials fail. According to one study, only 13.8% of drug development programs lead to approval. For those that succeed, it takes 7.5 years, on average, from the start of clinical testing to marketing. Trials that support FDA approval of new drugs are estimated to cost anywhere from $19 million to $2.9 billion, meaning the stakes are high.

Technology advances address some of the most common challenges that can tank studies and bias results, from poor study design and ineffective site selection to failure to recruit and participant dropout. Let's look at a few, including artificial intelligence, decentralized clinical trials, and wearable devices.

Artificial intelligence

The world of artificial intelligence (AI) is buzzing with a new word - ChatGPT. It's the best AI chatbot ever released to the public. Already, ChatGPT has been named as a co-author on at least four scientific papers, is helping programmers fix errors in code, and has tried to convince one man to leave his wife - impressing and distressing millions of people since its launch in late-2022. It even passed all three parts of the US Medical Licensing Exam.

The hype surrounding the splashy chatbot represents a significant step forward in the potential of AI. Most of us are only now getting a glimpse of just how far the technology has come, but AI is already reshaping key steps of clinical trials. Here's how:

• Patient recruitment: Patient recruitment is one of the most difficult parts of the clinical trial process. More than 80% of clinical trials fail to enroll on time. AI is fast emerging as a solution. For example, John Hopkins researchers are using an AI-based tool from Viz.ai to expedite enrollment in a brain injury trial. The tool scans patient data in real-time to identify trial candidates and notifies research teams. Similarly, researchers at Cedars-Sinai Heart Institute used software developed by Deep 6 AI to find 16 participants for a trial in an hour. The conventional approach only turned up two participants in six months.
• Predictive modeling: AI can also predict study outcomes by mining through patient records and finding patterns or making individualized predictions for response. One study used machine learning (ML) techniques to predict improvement of depressive symptoms for patients receiving antidepressant treatment based on pre-treatment symptom scores and EEG measures. Another study found that an ML model could accurately predict cancer treatment outcomes in clinical trials, including how long patients would live without cancer progression and their overall survival.
• Clinical trial design: Another area AI shows promise in is clinical trial design. AI models can extract information from trial documents and evaluate how each component of the trial protocol affects the outcomes. This approach has been demonstrated in drug discovery and is quickly growing in popularity for trial design.

We dig deeper into how the life sciences industry can speed up the drug development pipeline - and the issues facing clinical trials - in episode 13 of the Definitively Speaking podcast: How academia and start-ups can accelerate the drug development pipeline with Pam Randhawa.

Virtual and decentralized clinical trials (DCTs)

Artificial intelligence isn't the only tech changing the face of clinical trials. Decentralized clinical trials (DCTs), alongside digital tools for remote measurement, are taking the medical research world by storm.

Historically, medical research has been carried out in person at academic institutions, limiting potential participants to those who live near study sites. DCTs use technology - like electronic consent, wearables, and remote patient monitoring - to conduct some or all aspects of the trial remotely.

While the pandemic invigorated more support for DCTs, they're not entirely new. Pfizer carried out the first entirely virtual clinical trial in 2011. The trial used mobile phone and web-based technology to collect data without clinic visits.

By meeting patients where they are, DCTs broaden access to a larger and potentially more diverse pool of patients, such as low-income and rural patients. Patients who would otherwise face daunting obstacles from centralized trials, like travel costs and job absences, may be able or willing to enroll in DCTs.

For example, more than 400,000 participants enrolled in Stanford University's Apple Heart Study, a virtual study that uses the Apple Watch to detect irregular heart rhythms, like atrial fibrillation - a leading cause of stroke.

Another potential boon for clinical trial sponsors? More data, more often, and more easily collected than ever before since many virtual trial tools, like the Apple Watch, capture data passively at home.

With rising acceptance of digital health, there's little doubt DCTs have "arrived" and are poised to change the clinical trial industry both now and into the future.

A changing regulatory landscape could boost diversity

Minority representation in clinical trials is low. According to the Food and Drug Administration (FDA), 75% of clinical participants in 2020 were white, 11% were Hispanic, 8% were Black, and 6% were Asian. Yet, one in five drugs respond differently across racial and ethnic groups.

To tackle the diversity challenge, the FDA will soon require researchers and companies seeking approval for late-stage clinical trials of drugs, biological products, and medical devices to submit a plan for ensuring diversity among trial participants. The agency released draft guidance in June 2024 outlining these new requirements.

Addressing diversity is crucial to ensuring studies are inclusive and representative of the populations they're intended to serve. Doing so can help make sure research findings are generalizable to the entire population and can lead to more equitable healthcare outcomes for everyone.

Retail giants are jumping into the clinical trial game

It's well known that retail behemoths are moving into healthcare delivery - offering everything from vaccinations to primary care visits. What's lesser known is that these heavily trafficked neighborhood retailers are carving out a niche in clinical trials.

It's a no-brainer for retailers: By leveraging their immense customer base and network of stores, retailers can offer clinical trial sponsors access to a broad and diverse patient population, making it easier to recruit participants and conduct trials on a larger scale. Retailers also stand to gain new revenue streams from drug companies by tapping into trials.

Key retail players in the clinical trial space include Walgreens and Kroger. Since 2022, Walgreens has notched over 35 clinical trial deals with life sciences companies, including a notable collaboration with drugmaker Boehringer Ingelheim to connect patients with obesity or diabetes to trials for the GLP-1 drug survodutide. The pharmacy giant also has a 5-year contract with the U.S. government to expand access to decentralized clinical trials.

In 2023, Kroger launched a clinical trial site network to increase diversity in drug research and make trials more accessible to underrepresented groups, such as minority populations. Kroger's inaugural trial, conducted in partnership with Persephone Biosciences, focuses on identifying microbiome-based biomarkers for colorectal cancer, one of the most common cancer diagnoses. Kroger also partners with Janssen Pharmaceuticals on a vaccine trial to prevent blood infections.

Despite the potential benefits, transforming retail clinics into clinical trial hubs is not without challenges. The closure of CVS Health's clinical trial business in 2024, just two years after its launch, underscores these complexities. Nevertheless, such setbacks may lead to new strategies and offer fresh opportunities for retail giants to boost access to clinical research.

Learn more

Overall, these developments point to a future where clinical trials are more diverse, patient-centered, and technology-driven than ever before. Want to learn more about clinical trials and how you can leverage existing intelligence to target areas for new clinical studies? Definitive Healthcare tracks clinical trial metrics for more than 9,400 participating hospitals and health systems, and more than 1 million participating physicians across the U.S. Start a free trial today.

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