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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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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has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.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 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 In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. medical access, such as social determinants of health.

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

The Pharma Data

Biomarkers will be critical to developing precision medicine for Alzheimer’s disease. Although a few are out there, phosphorylated tau (P-tau) may enable even earlier and more accurate detection, according to Eli Lilly-associated researchers speaking at the Clinical Trials on Alzheimer’s Disease (CTAD) virtual conference in early November.

Disease 52
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What are the top disease areas for clinical drug trials?

Drug Discovery World

Breast cancer retained its position as the most-studied disease area in clinical trials in 2022, according to a recent report by analytics company Phesi. Here, we take a look at the top four disease areas and some of the key developments in 2022.

Trials 130
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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.