clinical trials

As the complexity, sophistication, and size of clinical trials have grown exponentially, the need for specialized expertise—often spanning various regions around the globe—has also expanded, along with the demand for flexible staff allocation. Consequently, clinical operations staffing has undergone significant transformations in recent years. The trend has shifted from relying on direct internal hires, to…

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…

The global AI drug discovery market, valued around $1 to $1.7 billion in 2023, will be worth a multiple of that by the decade’s end. Analysts project the sector could be worth $9 billion or more. 2024 Nobel Prize in Chemistry Recipients: David Baker Demis Hassabis John Jumper Achievement: Computational protein design and structure prediction…

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…

The digital pathology firm PathAI has released PathExplore Fibrosis, an AI-based tool that analyzes fibrosis and collagen structures from H&E-stained whole-slide tissue images. The software quantifies fibrotic areas and collagen fibers from standard pathology slides, replacing specialized staining techniques and microscopy equipment. The tool processes large datasets of tissue images, designed to work with existing…

Although Lilly has shared the topline results of the SURMOUNT-1 trial, now, the full data from the three-year study have been published in the New England Journal of Medicine. The company also recently presented the data at ObesityWeek in San Antonio.  The biggest conclusion was that 98.7% (752 of 762) of participants who received tirzepatide…

Clinical trials are notoriously expensive, with Phase 3 studies costing upwards of around $55,000 per day and completed trials routinely costing in the tens of millions of dollars. The startup Unlearn aims to chip away at those costs using digital twin technology, a concept pioneered by NASA during the Apollo era to create ‘living models’…

ChatGPT may be one of the quickest adopted tech platforms in recent memory, but the potential of it and other large language models ability transform the world has also been met with occasional provider outages, hallucinations, and memory problems. “There’s a lot of resentment towards the hype,” notes Christopher M. McSpiritt, head of life sciences…

Abstract Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard and Zoé Felicié, patient diversity experts at the PPD Clinical…

Traditionally, only a small fraction of oncology drugs make it from phase 1 to commercialization. And biopharmaceutical companies continue to face significant challenges in understanding how new oncology drug approvals affect treatment patterns and market share. To deal with such hurdles, Oracle has recently launched CancerMPact Treatment Architecture Trends (PDF overview here), a resource that…

Scorpion Therapeutics’ new oral cancer drug, STX-478, showed promising anti-tumor activity as a monotherapy in a Phase 1/2 trial, achieving an overall response rate (ORR) of 23% in breast cancer and 21% across all tumor types studied. The data were unveiled at the European Society for Medical Oncology (ESMO) Congress 2024, held 13–17 September 2024.…

Updated results from the Phase 3 NATALEE trial reveal that Kisqali (ribociclib) significantly cut the risk of recurrence in patients with HR+/HER2- early breast cancer. Adding Kisqali to standard endocrine therapy (ET) resulted in a 28.5% reduction in invasive disease-free survival (iDFS) events compared to ET alone (HR=0.715; 95% CI: 0.609–0.840; P<0.0001), Novartis announced in…

QuantHealth, an AI-focused clinical trial design company based out of Tel Aviv, has announced the completion of more than 100 simulated clinical trials, reporting an 85% accuracy rate. The company, which received $17 million in a Series A funding round with backing from Accenture, aims to chip away at the steep costs and stubborn timelines…

Eli Lilly’s hit drug tirzepatide has demonstrated a 94% reduction in the risk of developing type 2 diabetes among overweight and obese prediabetic adults, according to new findings from a 176-week Phase 3 trial. The SURMOUNT-1 study, the longest completed trial of tirzepatide to date, also showed sustained weight loss through the treatment period, with…

Medicare is taking its scalpel to drug prices, excising billions in costs for popular medications like Eliquis and Jardiance. The Biden-Harris Administration announced significant agreements with drug makers that would cut list prices by up to 79% for the first 10 drugs selected under the new Medicare drug price negotiation program. CMS announced last year…

In a double-blow to psychedelic therapy, the FDA has rejected an application for MDMA-assisted treatment of PTSD, while a prominent medical journal has retracted three key papers on the subject. The agency, which had granted Breakthrough Therapy Designation to MDMA in 2017, signaled it may be open to changing its mind if presented with data…

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…

In drug development, time lost is literally money lost and every day of delay can potentially cost millions. People in the industry are exploring new strategies to get drugs to market faster with potentially fewer patients, as Pina D’Angelo, VP of Biometrics at Innovaderm, pointed out. Adaptive clinical trial designs can be a notable tool…

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…

Phesi, a Connecticut-based clinical development analytics company, has published research in Bone Marrow Transplantation showing the potential of digital twins to replace standard-of-care control arms in clinical trials. The study focused on chronic graft versus host disease (cGvHD), a serious complication affecting 30–50% of the 50,000 cancer patients who receive hematopoietic cell transplantation (HCT) each…

One of the top promises of artificial intelligence/machine learning in drug discovery is reversing decades of dwindling productivity. But imagine if the technology makes good on its promise. And perhaps six or seven years from now, in which productivity is doubled, leaving pharma firms to have, theoretically, early stage pipelines that are twice as large.…

Boehringer Ingelheim has partnered with Gubra, a specialized biotech company and preclinical CRO that specializes in peptide-based drug discovery for metabolic diseases, to launch phase 1 clinical trials for BI 3034701. This drug candidate is a long-acting peptide designed to target three different receptors associated with weight loss, offering a potential new avenue for tackling…

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…

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…