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Clinical research is about trial and error

pharmaphorum

Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drug trials and the important role of participants in clinical research.

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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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STAT+: Pfizer scraps half of participants in Lyme disease drug trial due to quality issues

STAT News

Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator.

Trials 119
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Study coordinator pleads guilty to trial data falsification

Outsourcing Pharma

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

Trials 98
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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

The need for new medical treatments and drugs has never been greater. But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S.

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has been some interesting news related to clinical trials this week, with the announcement that the FDA has published draft guidance to modernise the design and conduct of studies, and the failure of Bellerophon Therapeutics’ Phase III study in fibrotic Interstitial Lung Disease.

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STAT+: Pharmalittle: Private equity moving to buy clinical trials firms; data provider limits media access to drug prices

STAT News

And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.