Medical Innovation Exchange

DCTs

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research     Artificial intelligence (AI) and machine learning (ML) are poised to be play a pivotal role in clinical trials by automating patient recruitment, data collection and analysis. However, most AI algorithms primarily rely on databases from populations of …

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FDA Announces Additional Steps to Modernize Clinical Trials

FDA Announces Additional Steps to Modernize Clinical Trials     On June 6, the FDA released E6(R3) Guideline for Good Clinical Practice, a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates …

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FDA Issues Draft Guidance on Use of Decentralized Clinical Trials

FDA Issues Draft Guidance on Use of Decentralized Clinical Trials     The FDA has published a new draft guidance on the use of decentralized clinical trials (DCT), which it defines as a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. “Decentralized Clinical Trials for …

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