clinical trials

One of the biggest frustrations for anyone involved in clinical research or patient care is the continued challenges of advancing pre-clinical research into a clinical trial. Likewise, finding and recruiting ideal clinical trial participants for each trial phase, such as those with rare conditions or whose current health condition matches stringent clinical trial inclusion criteria,…

​Over 300 million people worldwide live with a rare disease, yet roughly 95% of these conditions lack an FDA-approved treatment. Traditional clinical trials face significant challenges in this segment. Barriers include small patient populations with correspondingly limited statistical power. Yet emerging biosimulation and virtual trial methods offer a promising path forward., says Oxana Iliach, vice-chair…

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…

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…

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…

Tel Aviv-based QuantHealth is on a roll. In August 2024, it surpasses the 100th mark in simulated clinical trials with an 85% accuracy rate and reported cost savings upwards of $215 million for one major pharmaceutical partner. In March of the same year, Fast Company recognized QuantHealth as one of the most innovative companies in…

Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…

From FHIR-based APIs to “hybrid data models” and blockchain-enabled audit trails, biopharma companies are exploring a range of strategies in their quest to incorporate Real World Data (RWD) into clinical trials. But technology alone won’t resolve the deeper issues at play. From bridging disparate data sources to safeguarding patient privacy under evolving regulations, sponsors face…

Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…

To the untrained eye, psoriasis might look like a simple skin condition, marked by itching, scaly patches. Yet psoriasis is an immune-mediated disease with systemic consequences. As Dr. Graham Heap, vice president and global program leader at Takeda, explained during a recent interview, “Psoriasis might manifest as plaques on the skin, but it’s an immune…

A growing chorus of experts agree: 2025 signals a year when AI and its generative variants (genAI) move beyond early experimentation into a period of tangible, large-scale impact — including in the life sciences. While challenges remain as EY recently noted, the future will likely be one where the focus shifts from anticipating breakthrough genAI…

Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations.  When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…

The development of Proteolysis Targeting Chimeras, or “PROTACs*,” has garnered significant attention in the pharmaceutical industry due to their potential to target and degrade disease-causing proteins previously considered undruggable. As a novel therapeutic modality, PROTACs offer a promising alternative to traditional small-molecule inhibitors and biologics. However, despite the excitement around these therapies, preclinical evaluations of…

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…