Over the last year, the kinds of clinical trials that precede a drug’s approval have been in the headlines more than ever. The way in which this technical process has become an international talking point is just another strange example of 2020 being unprecedented.
COVID-19 has the entire country following every step of the approval process for vaccines from pharmaceutical giants like Moderna, Pfizer, and AstraZeneca. From initial demand, to human trials, to distribution, the world has been watching. We are desperate to put the pandemic behind us, and many experts think that a vaccine is the best way to do it.
There was a lot of innovation that went into bringing a drug to market so quickly, and recently FDA has issued emergency use authorization for a COVID-19 vaccine from Pfizer. In many ways, this new approach could be an indication of things to come concerning flexibility in clinical trial design.
Before coronavirus became a pandemic, Maria Picone was fortunate enough to be able to sit down with Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA to talk about the best ways to provide flexibility in clinical trials. Dr. Woodcock has been at the forefront of finding creative ways to get treatments to the rare disease patients who need them the most. She was also involved in Operation Warp Speed. In fact, the day of the following interview, she was running behind schedule—Coronavirus was beginning to take the shape of a pandemic.
This conversation is more relevant now than ever before. Now that we have seen the amount of inventiveness that was employed to accelerate the creation of a COVID vaccine, hopefully a silver lining of this pandemic will be our ability to apply this innovation to rare disease treatments.