The World Health Organization (WHO) is calling for the disclosure of results from all clinical trials for drugs, devices and vaccines, including older, unreported trials. In addition, all trials should be registered on a WHO primary clinical trial registry so they can be accessed through the International Clinical Trials Registry platform, the WHO said. Failure to disclose results leads to misinformation that can skew R&D priorities and public health interventions, creating indirect costs for patients, industry and the public sector. The WHO cited a study that found 23 percent of the trials registered on ClinicalTrials.gov and completed by 2009 had no results reported. The unreported trials included nearly 300,000 participants.
The EMA released two draft good practice guides to improve the reporting, evaluation and prevention of medication errors by regulators and drugmakers. One guide focuses on the prevention of medication errors, which are defined as unintended and potentially harmful mistakes in the prescribing, dispensing or administering of a drug. The draft describes the main sources and types of errors and proposes ways to minimize the risk of errors throughout a drug's life cycle. The second guide advises on how suspected adverse reactions caused by medication errors should be recorded, coded, reported and assessed. It also discusses how information on medication errors that haven't caused adverse reactions should be reported in periodic safety update reports and the risk management plans that are compulsory for all drugs. The EMA also released an addendum to the guides that focuses on the risk of medication errors linked to new high-strength insulin and other drugs containing insulin. Comments on the guides and addendum are due by June 14.
The National Institutes of Health (NIH) is supporting the placebo-controlled REPRIEVE trial to test whether statins can reduce the risk for major adverse cardiovascular (CV) events in people with HIV, who may be up to twice as likely to have heart attacks and other forms of CV disease. Investigators from Massachusetts General Hospital/Harvard Medical School, the Harvard School of Public Health and Duke University will conduct the trial in collaboration with the NIH-funded AIDS Clinical Trials Group. About 6,500 HIV patients, ages 40-75, will be randomized at 100 sites in Canada, Puerto Rico, Thailand and the U.S. The trial will test a daily dose of pitavastatin (Livalo), donated by Kowa Pharmaceuticals America Inc. In addition to following the participants for up to six years, the researchers will conduct a substudy of 800 subjects to examine pitavastatin's effects on coronary artery disease and inflammatory biomarkers in people with HIV.
The National Institute of Environmental Health Sciences/National Toxicology Program is seeking comments on a set of human genes identified and prioritized as environmentally responsive genes. The goal is to generate a set of about 1,500 human genes that can provide maximal toxicogenomic information on effects from chemical exposures that reflect general cellular responses, as well as gene expression changes that are specific by organ or cell type, according to a notice in Wednesday's Federal Register. The gene set also may be used in biomarker development and basic research. Comments on the gene set are due by May 15.