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The unsustainability of clinical trials and need for transformative change

Pharmaceutical Technology

The present clinical trial ecosystem is not equipped nor projected to have the capacity to satisfy this demand, and as a result the ecosystem is facing a potential slowdown in drug development. Rare disease trials, by definition, struggle with small patient pools scattered across the globe.

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How to Successfully Employ External Comparator Arm Studies Using Real World Data

pharmaphorum

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. In the general case, RCTs are the optimal approach to clinical research and drug development. Discussion.

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The Use of Artificial Intelligence in the Pharmaceutical Industry

Viseven

This article will cover the most important areas of AI influence on the pharma industry and new drugs development. From life-saving drugs discovery, development, and production to clinical trials, communication, and drug target identification — AI pharmaceutical is a definite game-changer. Clinical Trials.

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Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

FDA Law Blog: Biosimilars

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,