Clinical trial protocols become overly complex because teams copy and paste from previous studies, accumulating unnecessary data points and criteria. Merck advocates for "protocol lean design," which starts from the core research question and rigorously challenges every data collection point to reduce site and patient burden.

A blinded central radiology review is not the absolute gold standard for assessing patient progression. Expert clinicians argue their holistic assessment, incorporating the patient's clinical status and other biomarkers alongside scans, provides critical context that a disconnected reviewer lacks.

Competitive advantage in the weight-loss drug market is shifting from maximizing total weight lost to the *quality* of that loss. The next frontier involves preserving muscle while reducing fat and minimizing side effects like nausea. This signals a market evolution toward more nuanced, patient-centric solutions beyond a single metric.

Patients report a temporary, fully reversible blue-gray tint to their vision. This occurs because the drug's target, GSK, is present in eye photoreceptors. Rather than a major concern, this manageable 'nuisance side effect' serves as a real-time biological marker that the drug is successfully engaging its target systemically.

Radioligand therapy has a unique toxicity profile, described as 'the gift that keeps on giving,' where side effects can worsen even after the treatment course is complete. This contrasts with chemotherapy like docetaxel, where a patient's quality of life often rebounds and improves once the drug is stopped.

After a decade on the market and multiple shifts in endpoints, Sarepta's definitive Phase 3 study for its DMD drugs failed. This outcome casts doubt on the entire accelerated approval framework for slowly progressive diseases, where surrogate endpoints may not translate to clinical benefit, leaving regulators and patients in a difficult position.

The bottleneck for AI in drug development isn't the sophistication of the models but the absence of large-scale, high-quality biological data sets. Without comprehensive data on how drugs interact within complex human systems, even the best AI models cannot make accurate predictions.

The term "depression" is a misleading catch-all. Two people diagnosed with it can have completely opposite symptoms, such as oversleeping versus insomnia or overeating versus appetite loss. These are not points on a spectrum but discrete experiences, and lumping them together hinders effective, personalized treatment.

The company's clinical trials go beyond standard pain scores to track improvements in function, sleep, and patient satisfaction. Demonstrating that patients can climb stairs, drive, and sleep better provides a more compelling value proposition for a faster return to normal life, resonating with patients, surgeons, and payers alike.