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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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This week in drug discovery (5-9 June)

Drug Discovery World

There has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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This week in drug discovery (6-10 February)

Drug Discovery World

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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What are the top disease areas for clinical drug trials?

Drug Discovery World

Results from the PROVENT Phase III trial showed a significant reduction in the risk of developing symptomatic Covid-19 and that the protection continued for at least six months. Prostate cancer A new metastatic prostate cancer drug was approved by the FDA in March, followed by the European Commission in December.

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 In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials.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

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