Prashant Kumar

In cancer research, nothing is more important than proving whether a treatment helps patients live longer. That’s why “overall survival” (OS) is considered the gold standard in oncology trials—it’s clear, objective, and clinically meaningful. The FDA’s new draft guidance sheds light on how sponsors should design, analyze, and report OS data to ensure that cancer … Read more

Twenty years ago, U.S. politics—not science—slammed the brakes on embryonic stem cell research, delaying lifesaving breakthroughs for a generation. Now, the same playbook is being dusted off—this time targeting mRNA vaccine technology, the very innovation that helped save hundreds of millions of lives during COVID-19. If history is any guide, this short-sighted decision will cost … Read more

Imagine walking out of your doctor’s office with a grocery list and a cooking plan instead of another prescription. At UT Southwestern Medical Center, that’s exactly what’s happening. Through a pioneering culinary medicine program, doctors and dietitians are teaching patients how to cook their way to better health—and the results are turning heads in the … Read more

Investing in quality management isn’t just about regulatory compliance; it’s a strategic move that boosts efficiency, profitability, and public health outcomes. An FDA white paper presents a systematic analysis of how mature quality systems can provide both economic and public health benefits to the industry. There are no surprises in the paper; it provides the … Read more

Observational studies play an important role in medicine by providing insights not available from controlled clinical trials, but many suffer from poor transparency and inconsistent methods. Their potential is often compromised by bias, data dredging, and unverifiable conclusions. Could registering the observational studies address the concerns with their reliability and unlock their full potential to … Read more

Artificial intelligence is increasingly powering your doctor’s decisions. But as AI advice becomes a staple in modern healthcare, a surprising trend is emerging: patients aren’t quite ready to trust it. Artificial intelligence (AI) is making its mark on healthcare, offering unprecedented support in diagnostics, treatment planning, and even behind-the-scenes administrative work. But new research reveals … Read more

Real-world data is being hailed as the next big thing in clinical research, but the reality is a bit messier. Until we clean up the data and rethink how we collect it, real-world evidence risks being a shiny promise with little power. The explosion of electronic health records (EHRs) and digital claims databases was supposed … Read more

Two-to-one (2:1) randomization has become a common feature in clinical trial design, particularly in oncology, often under the belief that it helps recruit more patients by increasing the chances of receiving the experimental treatment. But according to Freidlin and Korn in their recent JCO Oncology Practice article, this practice may be more problematic than promising. … Read more

In a sweeping regulatory shift that’s already sending shockwaves through the global supply chain, the U.S. Food and Drug Administration (FDA) has officially revoked the longstanding exemption for low-value imports. As of July 9, every shipment of FDA-regulated products—regardless of its dollar value or size—must now undergo full FDA review. This marks the end of … Read more