Biomarkers are strategic assets for biopharma companies, significantly improving the success rate of clinical trials1. Yet, discovering them often feels like navigating through a blizzard of unstructured information, searching for the one true signal that can guide the way. While laboratory automation has eased benchwork, the real storm rages in the data, obscuring access to…
Early-phase study design considerations for long-term follow-up in vaccine clinical trials
Healthcare is one of the largest sources of “big data,” accounting for upwards of 30% of all data produced globally.1 Early on, the potential benefits of this data for healthcare outcomes were immediately evident. As that promise has begun to materialize, with the advent of AI and machine learning, real signals of improvement in therapeutic…
How a ‘rising tide’ of inclusivity is transforming clinical trials
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…
External comparator studies: What researchers need to know to minimize bias
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…
FDA rejection of MDMA and journal retractions jolt psychedelic therapy research
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…
QuantHealth taking a data-driven predictive approach to simulate clinical trials
In drug discovery, the process of shooting for regulatory approval can feel less like a sprint and more like a marathon, but with no guarantee of crossing the finish line. Despite the hefty investment of time, effort and resources, the success rate for bringing new drugs to market hasn’t improved in recent decades. The American…
How AI-based technologies improve clinical trial design, site selection and competitive intelligence
Clinical trials form the cornerstone of evidence-based medicine and are essential to establishing the safety and efficacy of new drugs. However, only some of the information in clinical trial reports is well-structured and searchable via keywords; much of the information is buried in unstructured text. In the past, uncovering actionable insights from this unstructured text…