oig.hhs.gov

Food and Drug Administration’s Oversight of the Submission of Applicable Clinical Trial Results to ClinicalTrials.gov

The Food and Drug Administration (FDA) is responsible for ensuring that results of applicable clinical trials are reported to ClinicalTrials.gov within 1 year of the completion date. Clinical trials ...
Morgan

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and ...
ascopubs.org

Patient Enrollment to Industry-Sponsored Versus Federally-Sponsored Cancer Clinical Trials

Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma The conduct of ...
clinicaltrialvanguard

FDA Needs To Release ClinicalTrials.gov Guidance Now

The 2024 Clinical Trials Transformation Initiative (CTTI) report, drawing on a broad spectrum of responses from diverse stakeholders in the clinical trial community, sheds light on the significant ...
neurologylive

FDA Clears Aruna Bio’s Exosome AB126 for Clinical Trials in Neurological Indication

Aruna Bio's investigational treatment, AB126, is now set for a phase 1b/2a clinical trial targeting acute ischemic stroke, anticipated to begin in the first half of 2024. The FDA has cleared Aruna Bio ...
American College of Cardiology

Efficacy and Safety of Baxdrostat in Patients With Uncontrolled Hypertension - HALO

The HALO trial showed that baxdrostat 0.5 mg, 1 mg, or 2 mg daily did not significantly reduce BP compared with placebo among patients with uncontrolled HTN. In this phase 2 study, patients were ...