clinical trials

In recent years, the clinical research landscape has been marked by a steady rise in protocol complexity with more endpoints and procedures across all trial phases and therapeutic areas. This trend, driven by the increasing sophistication of trial designs, is evident across trial phases and major therapeutic areas. Resulting in more endpoints and procedures on…

One of the largest unmet needs in modern medicine is the effective treatment of osteoarthritis (OA)—a degenerative joint disease afflicting more than 30 million Americans and costing the healthcare system $459.5 billion in all-cause medical costs, according to a 2020 study in the Archives of Physical Medicine and Rehabilitation. “We see this as one of…

Imagine a shape-shifting pathogen invisible to the naked eye, armed with toxin-laced barbs that rupture human cells. This isn’t fiction—it’s Clostridioides difficile, a superbug causing 29,000 U.S. deaths annually through severe diarrhea and colitis. After an initial infection, up to 35% of patients experience recurrence, with subsequent episodes becoming increasingly likely—up to 60% of these…

Migraines, like many diseases, are not monolithic. In that regard, they are something like weather — they can shift suddenly, and predicting when they might arise can be elusive. Clinical trials traditionally capture a snapshot of the migraine storm, often failing to reflect the dynamic, lived experience of patients. Yet recent studies, including the phase…

NVIDIA today announced at JP Morgan partnerships with IQVIA, Illumina, Mayo Clinic and Arc Institute that center on accelerating biomedical AI across genomics, drug development, and clinical diagnostics. The collaborations aim to tap advanced computing across the healthcare sector, with IQVIA deploying AI agents for clinical trials, Illumina integrating genomic analysis tools, Mayo Clinic developing…

Second collaboration builds on rapid progress of AI-designed KAT6 inhibitor licensed in 2024 Agreement includes $20 million upfront payment with potential total value exceeding $550 million plus tiered royalties New preclinical asset demonstrates broad anti-tumor activity across multiple solid tumor types Less than a year after their first collaboration, pharmaceutical giant Menarini Group and AI-driven…

As 2024 drew to a close, the cell and gene therapy sector has witnessed a string of recent approvals and some positive clinical trial data such as Mesoblast’s Ryoncil receiving FDA authorization for pediatric graft-versus-host disease in December, Adaptimmune’s Tecelra gaining approval for synovial sarcoma in August, and the landmark clearance of Casgevy (Exagamglogene Autotemcel)…

In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…

The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…

Today’s large language models can be as unreliable as they are eloquent. Their tendency to fabricate facts and lose the thread makes them risky tools for scientific research, especially in highly regulated industries like pharmaceuticals and chemistry. They also struggle to provide sources and will fabricate a bogus academic journal without batting an eye. Speaking…

In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…

This case study is sponsored by Infor.  In the complex landscape of clinical trials and medical research, data fragmentation remains a major obstacle, hindering progress and patient outcomes. The case study “Advancing Clinical Trials and Research with Cloverleaf” showcases how Infor Cloverleaf significantly enhances clinical trials by integrating Real-World Evidence (RWE) to overcome data fragmentation.…

For millions living with rheumatoid arthritis (RA), the path to effective treatment is often a frustrating cycle of trial and error. Typically beginning with disease-modifying antirheumatic drugs (DMARDs) like methotrexate, the goal is low disease activity. Yet RA’s heterogeneity means many patients cycle through various therapies—biologic DMARDs like anti-TNF agents, JAK inhibitors, IL-6 receptor antagonists,…

Introduction Endometriosis is a chronic incurable gynecological condition with cyclical pelvic pain, heavy bleeding, infertility, and reduced quality of life as its main manifestations. Almost half of women with it experience infertility. [1] No symptoms are specifically pathognomonic or characteristic of endometriosis. Often referred to as a ‘silent disease’ because of how often the diagnosis…

Nine months into 2024, the search for effective neurodegenerative disease therapies continues, yielding a mix of promising advances and frustrating setbacks. After something of a lull in the 1990s and early 2000s, research into novel treatments for neurodegenerative diseases has surged back to life. One factor propelling the trend is the uptick in neurodegenerative disease…

Alzheimer’s clinical trials are among the most challenging and expensive studies to conduct with a 2021 study pegging the total costs since 1995 at $42.5 billion. Phase 3 trials are the biggest cost drivers, involving hundreds or thousands of participants. “We’re talking about studies with sometimes two thousand people per phase three clinical trial in…

Recursion Pharmaceuticals and Exscientia, two of the most prominent AI-driven drug discovery companies, are merging. The deal, which the firms expect to be official in early 2025, would create a portfolio of clinical and near-clinical programs with an expected 10 clinical readouts over the the next 18 months with “peak sales opportunities in excess of…

Liraglutide, a GLP-1 receptor agonist medication that first won FDA approval in 2010, may reduce cognitive impairment in Alzheimer’s patients. At this year’s Alzheimer’s Association International Conference, data from a Phase 2b clinical trial with 204 mild AD patients serving as participants was revealed, showing that the drug lowered decline in cognition by up to…

When it comes to medical AI, the biggest names aren’t necessarily delivering the best results. While tech giants race to build ever-larger language models, a new preprint reveals that when it comes to clinical accuracy and physician trust, a smaller player is outperforming the industry heavyweights. Putting large language model-based systems to the test Researchers…

The pandemic, the rise of decentralized trials and a wave of technological advances have each played a role in reshaping clinical trials and safety reporting. While these events have been changing the industry, the internet’s growing convenience and accessibility has also empowered and transformed the patient experience. Patients are increasingly turning to online platforms, particularly…

A group of prominent researchers and clinicians have published a consensus statement backing the use of MDMA-assisted therapy for post-traumatic stress disorder (PTSD). This statement comes as FDA is reviewing a New Drug Application for midomafetamine (MDMA) for the condition. “On the basis of the safety and efficacy data we have seen, assuming the integrity…

The recent FDA approval of Lilly’s Kisunla (donanemab) represents a significant win in Alzheimer’s drug development, a field that has seen a  decades of false starts and fizzled hopes. This approval, along with that of lecanemab in 2023, could mark a turning point in AD treatment. Alzheimer’s disease is reaching epidemic proportions with an estimated…

As pharma giants like Darmstadt, Germany–based Merck KGaA announce new pacts with AI companies, the drug development landscape is witnessing a familiar pattern of emerging tech adoption. AI’s promise of faster, more efficient drug discovery has captured the industry’s imagination, leading Big Pharma to ramp up investment in AI startups and partnerships. Yet, the technology’s…

In the emerging field of digital pathology, Aleksandra Zuraw, DVM, Ph.D., DACVP, is one of the most prominent voices. Her journey to this position, however, was far from straightforward. When Zuraw was 12, she dreamed of becoming a veterinarian, picturing herself following in the footsteps of the British veterinary surgeon James Herriot, tending to “All Creatures…

Today, Lilly announced promising data for the SURMOUNT-OSA phase 3 clinical trials testing tirzepatide in adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. The company shared the data at the American Diabetes Association’s (ADA) 84th Scientific Sessions while publishing them in The New England Journal of Medicine (NEJM). The SURMOUNT-OSA phase 3 trial consists…