For rheumatologists, research is important, but some clinical trials may not be worth collaborating on. In a recent interview, Hermine Brunner, MD, MSc, MBA, FACR, outlined important considerations to make when deciding to participate in a clinical trial to ensure a good fit…
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
PARIS (Reuters)—An initial report into a drug trial in northwestern France that left one person dead and five others hospitalized last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday. Touraine told a news conference that the condition of the five people who were hospitalized was improving and that…
NEW YORK (Reuters Health)—Authors should agree to share deidentified patient data as a condition for publication of a clinical trial report, according to a proposal from the International Committee of Medical Journal Editors (ICMJE). “Our patients generously and selflessly volunteer to participate in clinical trials on the promise that the knowledge gained will be used…
RENNES, France (Reuters)—A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the drug made…
PARIS (Reuters)—One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in western France of an experimental medicine from an unnamed drug company, the French health ministry said on Friday, Jan. 15. The ministry did not say what the medicine was intended to be used…
(Reuters Health)—Every year since 2006 in the U.S., the number of clinical trials funded by the National Institutes of Health (NIH) has gone down, while the number of industry-funded trials has gone up, a new study shows. Analyzing the ClinicalTrials.gov database, researchers found that after trial registration became a requirement for publication in major scientific…
(Reuters Health)—Drug companies are inconsistent about disclosing data related to clinical trials of new medicines, a new report says. Researchers examined publicly available data on clinical trials for 15 new medicines from 10 companies that were cleared for sale by the U.S. Food and Drug Administration in 2012. Two of the companies disclosed all trials…
In June 2014, 10 members of a church group returned to St. Louis from Haiti, where they had contracted chikungunya virus (CHIKV), a mosquito-transmitted alphavirus previously unknown in the Western hemisphere that produces inflammatory arthritis symptoms. Because CHIKV-related arthritis mimics seronegative RA, a group of clinicians, immunologists, virologists and geneticists at the Washington University in…
The U.S. Food and Drug Administration (FDA) has toughened the existing warnings for nonsteroidal anti-inflammatory drugs (NSAIDs) due to their stroke and myocardial infarction (MI) risk increase.1 Due to a continual review of these products, FDA is requiring label updates for all prescription NSAIDs. Over-the-counter (OTC) NSAIDs already list the increased risk of MI and…