“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”. Read more »

A new clinical trial for an AIDS vaccine will take place in Africa and the United States. The program, announced this week, is a collaboration between the International AIDS Vaccine Initiative (IAVI), which will lead the trial, biopharmaceutical company Crucell (Leiden, Netherlands), Harvard Medical School’s Beth Israel Deaconess Medical Center, and the Ragon Institute, an organization dedicated to HIV/AIDS research. Read more »

They may be well-meaning, but sometimes the EU’s decisions can have harmful effects, as is the case with its much criticized clinical trials directive. Read more »

The Office of the Inspector General at the US Department of Health and Human Services (HHS) issued a report this month citing the US Food and Drug Administration’s need to improve its oversight of foreign clinical trials. The report raises questions over the effectiveness of federal regulatory practices and resources to keep pace with an increasingly global pharmaceutical industry, and in doing so, also engenders larger policy considerations on how to best address this problem. Read more »

The US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »

Key results from a colon cancer study of Genentech’s Avastin (bevacizumab) could be available in April, according to a Securities and Exchange Commission filing. Genentech previously said results would be available mid-year. The drug is currently approved to treat breast and lung cancer, and it’s a first- and second-line treatment for metastatic colorectal cancer. Read more »

Normally, I don’t think much about research and development. I usually leave that subject to our sister magazine, Applied Clinical Trials. I do think about patient safety, though, and today an announcement on the website of the US Department of Health and Human Services (DHHS) got my attention.DHHS’s Office for Human Research Protections (OHRP) is soliciting public comment about a proposal to issue guidance recommending training for personnel who conduct, review, or oversee human clinical trials. I was surprised that such training was not already formalized.When I read a little more, I was even more surprised. Read more »

The idea of virtual clinical trials is not new, but its practice may soon be. A report released last week by PricewaterhouseCoopers (PWC), Pharma 2020: Virtual R&D, Which Path Will You Take?, suggests that the R&D process may be shortened by two-thirds come the year 2020. In addition, PWC predicts that success rates in the R&D process may dramatically increase and that clinical-trial costs could be cut substantially, thanks to new computer-based technologies. Read more »

FDA has disqualified more than 130 clinical trial investigators since 1964 for failing to follow certain regulations regarding data integrity and patient safety. Twenty-five of those investigators have been disqualified since 2001, and 7 of them were disqualified in the first half of this year. That doesn’t say much for 2008 as we still have six months to go. Read more »