Sun Pharma’s INSPIRE-1 and INSPIRE-2 studies met their primary endpoint at Week 24, with Ilumya 100 mg demonstrating superior ...

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research ...

New statistical frameworks such as net treatment benefit offer a multidimensional approach to evaluating efficacy, safety, and patient-centered outcomes in oncology trials.

Results from the Phase III PREVAIL trial (NCT05556096) of gefurulimab demonstrated a statistically significant and clinically ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research ...

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical ...

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how recent executive ...

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.