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Study shows anti-clotting drug reduced bleeding events in patients with atrial fibrillation

Science Daily: Pharmacology News

The trial was stopped early by the recommendation of the Data Monitoring Committee due to an overwhelming reduction in bleeding compared to standard-of-care treatment.

Drugs 290
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When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities

FDA Law Blog: Drug Discovery

However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.

FDA 105
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How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials

Crucial Data Solutions

Serious adverse events (SAEs) are among the most critical data points collected during a clinical trial. The post How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials appeared first on Crucial Data Solutions. The timeliness and accuracy.

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Rare Disease Day 2025: Rally for Rare Event Recap

Conversations in Drug Development Trends

The day inspires multiple events, such as fundraisers and scientific symposia, to bring together all the critical stakeholders who tirelessly work to make life better for those affected by rare diseases. In an incredible feat of collaboration, they were able to rapidly put together a new event called Rally for Rare.

Disease 69
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management.

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Enhancing Clinical Trials: The Power of Contact Center Services

PPD

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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The Power of Worldwide Networks in Data and Safety Monitoring Boards

Advarra

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.