31 August 2017 - Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening disease. It is an exciting time for medical innovation. 

Already, clinical trials have helped realise exciting and meaningful advancements for patients with critical diseases, like cancer, and thousands of clinical trials are currently underway looking at experimental therapies, combinations of therapies and new uses for existing therapies.

But with this hope comes the understanding that there are inherent risks for patients who are willing to participate in this type of research. While much effort is put into early research to ensure that no major safety issues exist before therapies are tested in patients, these trials are ultimately designed to provide vital information about the safety and efficacy of the treatments in people so the FDA can help ensure that the benefits to the intended patients outweigh the risks. When significant safety issues do arise, we must work quickly to prevent further injury or deaths.

Read FDA press release