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Phases of Clinical Research: A Detailed Overview

Advarra

Each phase has a different purpose in testing the treatment’s safety and efficacy. This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. Therefore, clinical research is a fundamental aspect of medical advancement.

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What the FDA’s guidance on diversity means for rare disease sponsors

Conversations in Drug Development Trends

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. Looking to diversify the reach of your orphan drug trial?

Disease 52
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Three Financial Conversations Biotech Leaders Need to Have in 2024

PPD

With fierce competition for available capital and resources, investors expect a clear demonstration of return on investment (ROI) — a factor on prominent display in industry research conducted by the PPD clinical research business of Thermo Fisher Scientific.

Trials 52
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Eli Lilly Designs P-Tau Biomarker Assay for Early Alzheimer’s Disease Diagnosis

The Pharma Data

This is encouraging as a pharmacodynamic biomarker in larger trials,” Dage said. The assay is being explored for applications in clinical research, including new drug trials, based on its capability to identify patients with Alzheimer’s disease and also to predict their risk of progression.

Disease 52
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How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

Regulatory organizations like Health Canada, the International Council for Harmonisation (ICH), and the European Medicines Agency (EMA) have long emphasized the importance of including diverse populations in clinical research. For example, elderly individuals are more prone to comorbidities, dementia, and functional decline.