A Spanish HIV/AIDS researcher is facing a hefty fine for violating clinical trial regulations. Vicente Soriano, a well-known clinical researcher with hundreds of publications to his name, is liable for €210,000 for conducting a clinical trial without approval from the Spanish Agency for Medicines and Health Products, failing to obtain insurance for the trial, and informing participants he had his hospital's ethical approval when he did not.
31 January 2014 | Science
As the FDA seeks to approve drugs not only more quickly but also accommodate a growing clamor to exhibit more flexibility for endorsing therapies for life-threatening diseases, a curious wrinkle has emerged – there is a wide variation in the quality of underlying evidence used for approvals.
22 January 2014 | Forbes
The lack of data on the effectiveness of medicines available to doctors and researchers is "of extreme concern" say a group of MPs.
The Public Accounts Committee is calling for all data on drugs being prescribed in the UK to be made available.
03 January 2014 | BBC Health
Principal investigators and clinical trials units (CTUs) have been chosen to lead and conduct the research of five HIV/AIDS clinical trials networks through 2021. The effort is directed and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Total funding for the networks' leadership and the CTUs is expected to reach $225 million in 2014, the first year of operation.
30 December 2013 | NIAID press release
A low-cost blood test may help inform HIV care providers on the accuracy of a self-reported new HIV diagnosis, according to recently published U.S. research. The research also provides a stark reminder that self-report alone may not be sufficient for differentiating recent from prior HIV diagnosis, particularly when enrolling volunteers in studies.
26 November 2013 | The Body Pro
An analysis of nearly 600 registered clinical trials published online October 29 in BMJ has shown that 29% remained unpublished 5 years after completion, that no results were available in ClinicalTrials.gov for three fourths of those unpublished trials, and that industry-funded trials were nearly twice as likely to go unreported as studies that had not received industry funding.
04 November 2013 | Medscape (requires free registration)
The conduct of clinical trials related to HIV cure research raises new issues that multiple stakeholders—regulatory agencies, scientists, biotech and pharmaceutical companies, HIV-positive people, activists, community advisory boards, and institutional review boards—are now beginning to discuss and address.
06 October 2013 | Treatment Action Group
Most scientific studies are wrong, and they are wrong because scientists are interested in funding and careers rather than truth.
09 September 2013 | BMJ Blogs
Recruiters for HVTN 505 cherry-picked times with peak traffic, such as Valentine's Day and Halloween. For a total of 22 days since the fall, ads worth $9,400 were blasted to all users within 30 miles of the Penn clinic. Grindr directed 18,000 visits to the trial's website.
09 September 2013 | Philadelphia Inquirer
An innovative vaccine based on whole killed HIV viruses has passed phase 1 human safety trials, researchers announcved yesterday. It boosted the production of antibodies in patients it was tested on.
05 September 2013 | Huffington Post