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Clinical trials news

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HPTN 052: Lessons learned from the 'ethical odyssey' of an HIV trial

HIV Prevention Trials Network 052 established that antiretroviral treatment in people who are HIV positive decreases the likelihood of transmitting HIV to their sexual partners. It serves as a case study of ethical challenges faced at every stage of the research trial process.

Published
15 June 2012
From
Eurekalert Medicine & Health
Report Outlines HIV Cure Research, Important Gaps

Three HIV/AIDS activist groups convened a meeting in March with researchers and representatives of the U.S. Food and Drug Administration (FDA) to describe the current state of cure research and identify barriers to moving such research forward swiftly and smoothly. The proceedings of this meeting, which took place immediately before the 19th Conference on Retroviruses and Opportunistic Infections (CROI) that began on March 5 in Seattle, are now available in a report online.

Published
26 April 2012
From
AIDSMeds
Academic spring: how an angry maths blog sparked a scientific revolution

Tim Gowers, a mathematician at Cambridge University, has hit a nerve with academics who are increasingly fed up with the stranglehold that a few publishing companies have gained over the publication and distribution of the world's scientific research.

Published
10 April 2012
From
The Guardian
What You Don’t Know, You Can Sell: Merck’s Cavalier Attitude Towards the Welfare of HIV/HCV Coinfected Patients

Despite outrage from activists, Merck refused to study drug-drug interactions (DDIs) between boceprevir (Victrelis), their HCV protease inhibitor, and drugs commonly used to treat HIV, putting coinfected study volunteers at risk for drug-drug interactions in their own clinical trial.

Published
10 April 2012
From
TAG
FDA Pain Patch Decision: Making a 'Sophie's Choice' with People's Lives

At the Food and Drug Administration (FDA) advisory hearing on Thursday, February 9, a panel of scientists and clinicians voted unanimously not to recommend approval of the Qutenza capsaicin patch for HIV neuropathy pain, based on data from 2 clinical trials. As the sole patient representative on the panel, it was an incredibly demoralizing experience.

Published
20 February 2012
From
HIVandHepatitis.com
HIV Experts Propose New Pathway for Conducting Phase 3 Drug Trials

We face a new scientific challenge: how to demonstrate the safety and efficacy of promising new antiretroviral drugs when the two traditional study designs – the superiority trial and the non-inferiority trial – are no longer useful in showing improvements in both “treatment experienced” patients and those who have never received drug therapy (treatment-naïve patients).

Published
07 February 2012
From
Forum for Collaborative HIV Research
Informed consent on trial

Lengthy, complicated documents leave many clinical-trial participants in the dark about the risks they face.

Published
06 February 2012
From
Nature
Pfizer tests a concept that could modernize drug studies

Pfizer, the world’s largest drug maker, is preparing to test a "virtual’’ clinical trial which would allow patients to participate from their homes, eliminating the time and expense of traveling to medical schools or other study sites.

Published
17 January 2012
From
NJ.com
Letter Opposing a Proposed Low-dose Stavudine Trial

We write as people with HIV and community activists with serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir.

Published
20 December 2011
From
Treatment Action Group
What’s up with the HIV clinical trials networks

Leaders of several HIV clinical trial networks shared information about the respective missions and agendas of these vital research consortia in one of the opening sessions at the Infectious Diseases Society of America 49th Annual Meeting.

Published
20 October 2011
From
Science Speaks

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