BREAKTHROUGHS BLOG

November 24, 2014

Research Roundup: Drug development costs, the price of priority review, new clinical trial requirements, and more

Marissa Chmiola
Communications Officer
GHTC

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

Last week we learned just how much pharmaceutical companies think a fast track review by the Food and Drug Administration (FDA) could be worth. Gilead Sciences paid US$125 million via auction to purchase a priority review voucher from Knight Therapeutics. This voucher will allow Gilead to shave four months off of the FDA review time for a drug of its choice. The priority review voucher system was created in 2007 to incentivize development of drugs for neglected diseases.

Bloomberg reports on a recent study out of the Tufts Center for the Study of Drug Development which found it costs pharmaceutical companies on average $2.56 billion to bring a new drug to market. This is more than twice the cost it took 11 years ago. According to the study’s author, this higher cost results from larger and more complex clinical trials, as well as the number of drugs that fail in development.

The Bill & Melinda Gates Foundation last week pledged $5.7 million to test potential treatments for Ebola. The research being funded will examine the effectiveness of using blood plasma taken from Ebola survivors to treat those infected, as well the effectiveness of an experimental antiviral drug called brincidofovir. While it has been common practice for decades for doctors to use blood donations from Ebola survivors as a form of treatment, there has not yet been rigorous studies conducted to examine the effectiveness of this practice until now.

The US Department of Health and Human Services last Wednesday unveiled new proposed reporting requirements or clinical researchers registering and submitting results to ClinicalTrials.gov. The most significant proposed change is that companies will be required to submit summary results from trials even if the product has not been approved or licensed for use in the United States.

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