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Drug Industry Taking Bigger Role in Clinical Cancer Trials

Drugs.com

1, 2024 -- Clinical trials sponsored by Big Pharma enrolled eight times as many patients as U.S.-government government trials did between 2018 and 2022, new research shows.The study -- conducted by researchers at Fred Hutch Cancer Center in. TUESDAY, Oct.

Trials 242
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Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog: Drug Discovery

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

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Regulations on Nutraceutical Clinical Trials in India Must-Know Facts

ProRelix Research

Stay informed on essential regulations governing Nutraceutical Clinical Trials in India, with a detailed look at ethical standards, CDSCO oversight, and trial conduct protocols.

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David Liu receives Breakthrough Prize in Life Sciences

Broad Institute

The organization has honored Liu for the development of the gene editing platforms base editing and prime editing, which can correct the vast majority of known disease-causing genetic variations and have already been used in at least 15 clinical trials, with life-saving results.

Science 144
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Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Conversations in Drug Development Trends

These designs facilitate streamlined trial logistics and centralized governance and create higher-quality data. Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. But how do they work, and when are they appropriate? What Are Master Protocols?

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Researchers Urge Greater Transparency for Government-Funded Vaccine Trials

The Pharma Data

More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies. Source link.

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