Drugmakers must do more to encourage side-effect reporting under a new industry code of practice published by the Association of British Pharmaceutical Industry. As of November, new promotional info must explicitly and “prominently” state that “adverse events should be reported” and provide details of the website to contact with concerns.
What else? Drugmakers will have to [...]

Drugmakers will soon be able to use data from foreign clinical trials in new drug applications even if trials only compare new products to placebos instead of best available treatments. The change departs from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the FDA’s previous standard, according to Integrity in Science Watch.
The [...]

The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports.
Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management [...]

Back in 2001, an infamous study was published in the Journal of the American Academy of Child and Adolescent Psychiatry that declared Glaxo’s Paxil antidepressant - called Seroxat in the UK - was “generally well tolerated and effective for major depression in adolescents.” Known as study 329, the findings were used to widely promote the [...]

The drugmakers say that a mid-stage clinical trial of an Alzheimer’s vaccine has been suspended while they look into a potentially serious side effect suffered by one patient in the study, Reuters reports. Dosing in the study of the experimental vaccine, ACC-001, was halted after the patient was hospitalized with skin lesions from what the [...]

The usefulness of some cancer meds is being exaggerated because drugmakers are stopping trials the moment they find a benefit, according to a study that will be published in Annals of Oncology, The Telegraph reports.
Researchers have discovered a sharp increase in the number of studies that are terminated early and argue that drugmakers are halting [...]

India has surpassed China to become Asia’s most popular destination for conducting clinical trials, reports The Times of India, citing India’s Planning Commission, which found that 139 new trials were outsourced to India recently compared to 98 in China. The market value for clinical trials outsourced to India is estimated at around $300 million, having [...]

The agency sent the drugmaker a harsh warning letter for failing to include nine Avandia post-marketing studies - seven clinical trials and two observational trials - in mandatory periodic and annual reports that are supposed to include a wide range of activities and events associated with each and every product. The FDA letter, which was [...]

In January, Erick Turner, a professor of psychiatry at Oregon Health & Science University and a clinician at the Portland VA Medical Center, shook up the medical community, provoked the pharmaceutical industry and, perhaps, disappointed millions of depressed Americans, Phil Dawdy writes in The Willamette Week. That’s because he published a paper in The New [...]

Let’s see. How about women, older folks, minorities, the diabled and people who live in the sticks. That’s the conclusion of a new analysis of the American clinical trial process for testing new drugs, which found these groups are routinely excluded or under-represented for decades.
“We’ve got a big problem,” Dan Goldberg, chief policy adviser for [...]