A new study revealed that the U.S Food and Drug Administration (FDA) have approved new drugs between 2005 and 2012 based on evidence supported by one large clinical trial. Experts recommend at least two.
The study looked into 188 drugs approved by the FDA between 2005 and 2012, and found that that majority of the new drugs were approved on the basis of two or more pivotal trials. "Pivotal trials" is a term used for clinical studies aimed to gather evidence for approval by regulatory boards. However, 37 percent of these drugs were approved after only a single pivotal trial.
"Some [drugs] are approved on very robust evidence, and some are based on preliminary evidence," Joseph S. Ross, study co-author and an assistant professor from Yale University School of Medicine, told the Wall Street Journal. "There is a lot of nuance at the time of approval that isn't well communicated to patients."
According to the study authors, FDA rules for approval of new drugs typically require at least two pivotal trials. However, the agency has the power to approve a drug on a basis of one pivotal trial only. However, scientists recommend at least two pivotal trials to ensure that the reliability and veracity of the data that backs up the drug's efficacy and safety.
FDA have already issued a written statement that the agency tailors their requirements for clinical trials for every individual drug or disease area but they make sure to impose the same approval requirements for the safety and efficacy of the drugs. Furthermore, the agency said that they have a strong surveillance program that they use to ensure that once the drug is released in the market, the benefits that it can deliver to consumers outweighs the risks associated with taking the drug.
"It's OK if we as society want these drugs to come to market more quickly, and be less rigorously studied at the time of approval, but I want that information conveyed to patients in a way they can understand it," Dr. Ross said to WSJ.
The study was published in the Journal of American Medical Association.
