On the 21st of January, I published on Biomed Central’s Blog network on marketing trials: Are clinical drug trials more marketing than science? Classic Trust The Evidence work this piece summarises the factors that influence the design of a clinical trial. The article is based on a long running piece of research published in Trials, which examined reports of randomized trials to deduce what characteristics appear to be influenced by marketing in the design of a clinical trials as... Read More | Share it now!
The problem Before carrying out a clinical trial, all outcomes that will be measured (e.g. blood pressure after one year of treatment) must be pre-specified in a trial protocol and on a clinical trial registry (e.g. clinicaltrials.gov). This is because if researchers measure lots of things, some of those things are likely to give a positive result by random chance (a false positive). A pre-specified outcome is much less likely to give a false-positive result. In the trial report, all... Read More | Share it now!
The available evidence suggests that there is inconsistency in the quality of evidence of approved orphan drugs, and there is no clear mechanism for determining their prices. In some cases, far cheaper generic agents appear to be available. A more robust, transparent and standard mechanism for determining annual costs is imperative. Several orphan drugs have been approved by the European Medicines Agency (EMA) over the past two decades. However, the drugs are expensive, and in some... Read More | Share it now!