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Phases of Clinical Research: A Detailed Overview

Advarra

The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.

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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 In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials.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.

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

The Pharma Data

“They will help researchers mechanistically assess target engagement in clinical trials,” and also will be used in clinical practice to identify the right drugs for the right patients, Howard Fillet, M.D., Importantly, “It demonstrated a lack of drug interference for each drug studied,” Dage said.

Disease 52
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How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.