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Category: Industry News

Posted on May 17, 2022 Government/Regulatory Industry News

FDA works to advance real-world data collection in pregnancy and lactation

Posted 16 May 2022 | By Mary Ellen Schneider  Sara Head, PhD, FDA Office of Women’s HealthThe US Food and Drug Administration (FDA) is working on ways to facilitate greater use...

Posted on May 17, 2022May 20, 2022 Clinical Trials Industry News

Real world evidence: Lessons learned from an FDA pilot show the limits of emulating RCTs

Only about half of a select group of clinical trials could be well-emulated with available real world evidence, according to the newly discussed results of an FDA pilot program. The...

Posted on May 17, 2022May 20, 2022 Industry News Synthetic Data

Anthem, Google Cloud training AI to detect fraud, abnormalities in patients’ health

Anthem partnered with Google Cloud to create a synthetic data platform that can train AI algorithms to identify fraudulent claims and abnormalities in patients’ health, The Wall Street Journal reported May 17. ...

Posted on May 12, 2022October 4, 2022 Industry News Marketing Survey

The Limited Future of Real-World Data

May 12, 2022 Michael J. Howley, PA-C, MBA, PhD , Peter Malamis, MBA Survey among pharma and CRO executives evaluates current usage of RWD. Real-world data is enjoying prominence after how well...

Posted on May 10, 2022May 16, 2022 Europe Industry News International

The Ecosystem: Can start-ups thrive in the European Health Data Space?

The EU plan to harmonise electronic health data promises to make life easier for start-ups, but barriers to success still remain By Ian Mundell Proposals to build a European Health Data...

Posted on May 5, 2022May 9, 2022 Industry News

Understanding Real-World Evidence and Data and Their Use

As life science organizations continue to leverage both real world data [RWD] and real-world evidence [RWE] in the product approval landscape, a more nuanced understanding of both RWD and RWE...

Posted on May 3, 2022May 9, 2022 Government/Regulatory Industry News

European Health Union: A European Health Data Space for people and science

Today, the European Commission launched the European Health Data Space (EHDS), one of the central building blocks of a strong European Health Union. The EHDS will help the EU to...

Posted on April 29, 2022 Industry News Oncology RWE Study

Real-World Data Confirm Lack of Standard Care for Triple-Exposed Multiple Myeloma

Sucharita Mistry, PhD Real-world data confirm that there is no standard approach for treating patients with triple-class-exposed relapsed/refractory multiple myeloma (RRMM), and these patients continue to have poor outcomes.  Researchers...

Posted on April 28, 2022April 29, 2022 Government/Regulatory Industry News

MDIC Publishes Framework on External Evidence Methods for Medical Devices

The Framework aims to assist stakeholders with use of new, innovative, and existing statistical methods for evidence fusion from data external to a clinical study. April 28, 2022 11:23 AM...

Posted on April 26, 2022April 27, 2022 Ethics Industry News Synthetic Data

Synthetic data in healthcare: privacy panacea or just hype?

Synthetic datasets could change the way developers train AI models in healthcare. They have the potential to increase the size of training datasets for AI models, whilst protecting patient privacy,...

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