Want to Know What Trials Supported FDA Approval? Look No Further.
[Posted on: Thursday, November 05, 2015] New drug approval by FDA is based on multiple clinical trials. It has always been hard for consumers to get a summary of all clinical trials conducted in support of a given drug. FDA recently created a tool to summarize the main clinical trials done to seek FDA approval. FDA recently released a web-page called Drug Trials Snapshot which provides an easy to review summary of clinical trials for drugs approved in the last 2 years. Most of the entries on the page are for drugs approved in 2015 while a few list the same information for 2014 decisions. The main purpose of the webpage is to provide an easy to find source for some common questions from consumers such as the demographic information on the clinical trial participants, common safety issues identified during the trials, main uses and risks. The information is similar to that provided in the product labels but is more visually appealing by giving graphical presentation and short plain language sentences. The main advantage is also its key limitation in that it is very simplified and abbreviated and even by FDA’s standards provides a partial overview of the drug label. FDA’s expects that consumers will review it only for introductory information and discuss with their doctors. Only time will tell how useful it really is.
|
|