clinical trial design

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…

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…

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…

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…

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…