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August 17, 2023: American Journal of Bioethics Publishes Special Issue on Pragmatic Clinical Trials

Rethinking Clinical Trials

When research and clinical care are deliberately integrated in an embedded pragmatic clinical trial, the nature and extent of investigators’ obligations to patient-subjects are blurred, as is the clinician’s duty to participate is such research. Some of the responses to the target articles are highlighted below.

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MHRA revamps UK clinical trial regulation with the promise of faster timelines

Pharmaceutical Technology

These changes come following a public consultation with the Healthcare Research Authority, to which a government response was published on March 21. Furthermore, the UK is now implementing a legislative requirement to publicly register clinical trials and share summary results with any research participants.

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January 31, 2023: New Article Suggests Moving From Idealism to Realism With Data Sharing

Rethinking Clinical Trials

The authors suggest that for data to be useful for new generative science or for reproducibility, the NIH should provide guidance regarding 5 important questions: What data should be shared and for what purpose? For more, read the full article , and see the Living Textbook chapter on Data Sharing and Embedded Research.

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A scientific approach to irrational consumer choices

World of DTC Marketing

The FDA wrote, “the researchers concluded that drug companies who create drug advertisements, as well as regulators who are responsible for reviewing promotional material, should pay special attention to ensuring that images accurately reflect drug efficacy.” Higher numeracy was associated with better gist and verbatim recall.”

Drugs 185
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Telehealth cuts overdoses for opioid users, says study

pharmaphorum

Greater use of telehealth services forced by COVID-19 seems to have benefitted people with opioid use disorder (OUD), leading to longer times on treatment and reduced risk of overdose, according to a new study. The authors say that the finding “lends support for permanently implementing access to telehealth services.”

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Excitement over new antibiotics that can kill drug-resistant bacteria

Drug Discovery World

A novel antibiotic class targeting a major global pathogen and threat to human health has been discovered by scientists from Roche and Harvard University (Cambridge, MA, US). Low market incentives In July 2023, a report by University of Queensland (UQ) researchers warned that a global crisis of antibiotic resistance is inevitable.

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Who Cares About Diversity in Clinical Trials?

WCG Clinical

Published by the Journal for Clinical Studies Volume 15 Issue 1 Mar 30, 2023 The imperative to obtain a diverse body of clinical trial participants has been stressed in public statements for decades; however, parties executing clinical trials have remained insufficiently effective in addressing it. appeared first on WCG Clinical.