In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how ...

In the ongoing Phase II CRDF-004 trial, onvansertib plus standard-of-care showed a 49% confirmed ORR and early PFS benefit in first-line RAS-mutated metastatic colorectal cancer, with a favorable ...

In Study 2 of the Phase III UP-AA trial, upadacitinib 15 mg and 30 mg met primary and secondary endpoints for scalp hair regrowth in patients with severe alopecia areata.

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, advises clinical research organizations to assess their portfolios, diversify funding sources, and ...

Results from the Phase III VIKTORIA-1 trial (NCT05501886) demonstrated that gedatolisib administered with fulvestrant, with or without Ibrance (palbociclib), showed statistically significant and ...

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance of long-term patient retention, data accuracy, and AI-driven compliance ...

In this video interview, Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, explains how clinical research teams can accurately report on diversity-related grant work while ...

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.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world evidence is helping refine patient targeting and improve safety monitoring ...

Results from the Phase III ABTECT-1 (NCT05507203) and ABTECT-2 (NCT05507216) trials showed that Abivax’s obefazimod demonstrated significant clinical remission in patients with ulcerative colitis.

Results from the Phase III BRUIN CLL-314 trial (NCT05254743) showed that Jaypirca (pirtobrutinib) achieved superiority in overall response rates compared to Imbruvica (ibrutinib) in patients with ...

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl ...