Remove Cardiology Remove Clinical Trials Remove Drugs
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Grand Rounds March 21, 2025: Generative Artificial Intelligence in Clinical Trials: A Driver of Efficiency and Democratization of Care (Alexander J. “AJ” Blood, MD, MSc)

Rethinking Clinical Trials

Its becoming more expensive and time-consuming to move a drug from the clinical trial stage to approval. Patient recruitment is the leading driver of costs in clinical trials, and 55% of trials that fail to complete cite low accrual rate as the reason for study termination.

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Integrating Bioanalytical Automation, Biomarkers, Pharmacogenomics, & Cost-Effective Strategies

Worldwide Clinical Trials

Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?

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Grand Rounds December 15, 2023: Diversifying Clinical Trials: A Path Forward (Roxana Mehran, MD, FACC, FAHA, MSCAI, FESC)

Rethinking Clinical Trials

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants. We have to change how we are practicing.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Lilly’s Lepodisiran Achieves Over 90% Reduction in Heart Disease Marker in Phase II Trial

XTalks

XTALKS WEBINAR: Keys to Success in Clinical Trials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinical trials.

Trials 59
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Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Rethinking Clinical Trials

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The drugs were administered open label and all patients were given a low dose of aspirin.

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LIB Therapeutics’ Cholesterol Lowering Med Lerodalcibep Receives FDA BLA Acceptance

XTalks

The FDA has set a prescription drug user fee act (PDUFA) target action date of December 12, 2025, and currently does not plan to hold an advisory committee meeting regarding the application. Over 2,400 patients have continued in the 72-week open-label extension trial.