Monday, September 24, 2018

Tag: clinical trials

The Truth About “Breakthrough” Drugs

From The Washington Post: "When federal regulators started giving certain drugs 'breakthrough' status in 2012, pharmaceutical company interest exploded. The goal was to speed up...

FDA Shakes Up Guidance on Antidepressant Trial Design

From MedPage Today: "The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder (MDD). For example, the new guidance...

Ethicists: Access Needed After Brain Implant Clinical Trials

In a new study, Baylor College of Medicine researchers have raised ethical questions about clinical trials of deep brain stimulation (DBS) and other brain implants. "'Generally,...

New Site Names Companies Who Fail to Report on Clinical Trials

From Pacific Standard: The U.S. government has never penalized anyone for breaking a law that requires institutions to report the results of clinical trials. A...

It’s Time to Levy Penalties for Failing to Report Clinical Trial...

From STAT: A decade after the Food and Drug Administration Amendments Act went into effect, requiring the results of clinical trials to be reported on the government website ClinicalTrials.gov, the government has never levied a single monetary penalty or withheld research funding under the law.

Failed TB Vaccine Exposes Concerns Regarding Research Ethics

An investigation exposes violations to research ethics, finding that researchers failed to disclose risks and even misled government agencies.

Irving Kirsch: The Placebo Effect and What It Tells Us About...

Dr Irving Kirsch is Associate Director of the Program in Placebo Studies and lecturer in medicine at the Harvard Medical School and Beth Israel Deaconess Medical Center. He joins us this week to discuss his research into the placebo effect and what it tells us about the efficacy of antidepressant drugs.

The State of the Evidence Base for Current Medical Products

In this post for Yale Law School's CRITical Thinking, Tom Jefferson discusses some of the factors that currently serve to undermine rational and ethical medical...

John Read: What the Science and Evidence Tell Us About Electroshock

Professor John Read talks about his research interests and in particular, the science and evidence base for Electroconvulsive Therapy (Electroshock).

Jim Gottstein: Patient Rights in Mental Healthcare

Jim Gottstein, president and founder of the organisation Law Project for Psychiatric Rights, talks about his own experiences with the psychiatric system, patient rights in mental healthcare and the recent trial between Wendy Dolin and the UK Pharmaceutical manufacturer GlaxoSmithKline.

Peter Gøtzsche: The Pharmaceutical Manufacturers Dominance of Mental Healthcare

Professor Peter Gøtzsche is Director of the Nordic Cochrane Centre in Denmark and discusses his background in research, his views on antidepressant prescribing and how pharmaceutical manufacturers have influenced mental healthcare.

Robert Whitaker: The Astonishing Rise of Mental Illness in America

We discuss Robert's 2010 book, Anatomy of an Epidemic, which is arguably the definitive account of the realities of psychiatric drugs and completely lays bare the astonishing rise in mental ill health despite the availability of psychiatric drugs.

Peter Groot: A Novel, Practical Solution For Those Withdrawing From Psychiatric...

Doctor Peter Groot from the User Research Center of the Maastricht University talks about Tapering Strips, which help users who want to withdraw from their psychiatric drugs safely and in a controlled way.

David Healy: Making Medicine Safer for All

Doctor David Healy from Bangor University in Wales talks about prescribing practice, medicine safety and pharmaceutical regulation.

Terry Lynch: Why Psychiatry Has Pursued a Purely Medical Approach to...

Doctor Terry Lynch is a GP, psychotherapist, author and mental health educator. Ten years into his career as a GP, he became very concerned about the medical approach to emotional and mental suffering and was not prepared to remain silent.

‘Salami Slicing’ Found in Analyses of Antipsychotic Trials

Evidence of duplicate publishing in articles analyzing data from clinical trials testing second-generation antipsychotics for depression

Researchers Make Recommendations to Improve FDA Transparency

Organizations, advocates, scholars, and practitioners had a chance to give feedback regarding FDA processes.

Pharma Data Sharing Efforts Off to a Slow Start

Researchers discuss the preliminary results of clinical trial data sharing efforts by pharmaceutical companies and other groups.

“Healthcare’s Dirty Little Secret: Results from many Clinical Trials are Unreliable”

For The Conversation, a team of researchers from the University of Aberdeen report that a substantial number of research trials produce unreliable results. “If that...

Study 329 Taper Phase

Most doctors still affect surprise at the idea SSRIs might come with withdrawal problems. Regulators knew very clearly since 2002 about the problems, but have decided to leave any communication of these issues in company hands.

Clinical Trials Underreport Harms of Antidepressant Medications

A group of researchers recently found serious bias in the reporting of harm due to adverse events in antidepressant medication clinical trials. They report...

Study 329 Continuation Phase

All the fuss about Study 329 centers on its 8-week acute phase. But this study had a 24-week Continuation Phase that has never been published. Until Now.

“New Federal Rules Target Woeful Public Reporting of Clinical Trial Results”

For STAT, Charles Piller covers new federal rules requiring stricter reporting for researchers conducting human studies. Previous investigations have documented widespread noncompliance with such...

“In Clinical trials, For-Profit Review Boards Are Taking Over for Hospitals....

Sheila Kaplan for STAT News: “The modern history of science is littered with studies in which participants were harmed because researchers failed to take...

“Jury Smacks J&J with $70M in Damages in Latest Risperdal Breast...

Fierce Pharma reports: "Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and...

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