2+ day, 17+ hour ago   (199+ words) Clinical Leader The Sponsor Consensus: How Trial Sponsors Are Thinking About Real-Time Clinical Trials The FDA's Real-Time Clinical Trials (RTCT) initiative aims to shift trial oversight from retrospective, episodic reporting to continuous, real-time review, an effort to compress development timelines…...

4+ day, 18+ hour ago   (229+ words) Clinical Leader Beyond A Single Disease: Traversing Complexity In Breast Cancer Clinical Development The science of breast cancer treatment is moving faster than many trial teams can operationally keep pace with. Precision medicine, biomarker-defined patient populations, novel therapeutic modalities, and…...

5+ day, 10+ hour ago   (501+ words) Guest Column | September 8, 2026 These questions frame the central challenge: Standards can give clinical information structure, but the context surrounding that information must remain connected as it moves across the trial life cycle. Clinical development spans scientific design, operational execution, data…...

1+ week, 5+ day ago   (401+ words) Guest Column | September 1, 2026 A conversation between Milken Institute Science Philanthropy Accelerator for Research and Collaboration (SPARC) Director Caitlyn Barrett, Ph.D., and Clinical Leader Executive Editor Abby Proch It’s been three years since an anonymous donor gave $96 million to Children’s National…...

2+ week, 3+ day ago   (613+ words) Guest Column | August 27, 2026 By David Adler, MD, Ph.D., MBA It may sound like an unlikely way to arrive at a career in oncology, but one of the earliest reasons I became interested in cancer was a child in my neighborhood…...

2+ week, 3+ day ago   (74+ words) Momentum around psychedelic drug development is accelerating, but these studies introduce operational challenges that many traditional CNS sites are not prepared to manage. In this brief article, we explore four factors that sponsors should consider when evaluating sites: As psychedelic…...

2+ week, 4+ day ago   (475+ words) Guest Column | August 26, 2026 A conversation between Vast Therapeutics CEO Nate Stasko, Ph.D., and Clinical Leader Executive Editor Abby Proch Nitric oxide has long held promise as an antimicrobial and immunomodulatory therapy in respiratory medicine, but its use has been limited…...

2+ week, 5+ day ago   (618+ words) Guest Column | August 25, 2026 A conversation between Oncolytics Biotech Scientific Advisor Richard Vile, Ph.D., and Clinical Leader Executive Editor Abby Proch Clinical Leader: For those of us who don't specialize in immunology, can you give us a primer, so to speak,…...

2+ week, 6+ day ago   (231+ words) Guest Column | August 24, 2026 By Eshaan Jain, Senior Consultant, Mphasis Most of the attention on that problem goes to speeding up any one of those agreements. The bigger gap is between them. A CTA typically defines the site's responsibilities for drug…...

2+ week, 6+ day ago   (146+ words) Clinical Leader Turning Patient Advocacy Into Meaningful Trial Engagement Building meaningful relationships with patient advocacy organizations (PAOs) is a critical step in advancing rare disease research, particularly for sponsors entering an unfamiliar therapeutic area. This case study explores how a…...