FDA Teleconference: Steps to Advance the Earliest Phases of Clinical Research in the Development of Innovative Medical Treatments
Thursday, January 12, 2006 10:15 a.m.
This text contains Dr. von Eschenbach's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.
Good morning, and thank you for taking time out of your busy schedules to join us. I am particularly grateful for your interest, because the steps that we announce today are a very important part of the FDA’s commitment to save lives and to create a healthier America.
Before I came to the FDA, as a surgical oncologist, I came to learn to ask of myself, no matter how many times I had done a successful surgical procedure, how it might have been done better or safer, to consider how even a very successful outcome might have been more successful. It’s just that kind of unflinching self-examination that brings us here today.
In March of 2004, the FDA released a landmark report called the Critical Path that outlined many of challenges that plague the process that guides drugs, biologics, and devices through approval and testing, on their way to becoming available to patients. The process, as that report made clear, is long and complex. It is expensive and, too-often, uses technologies of the last century to evaluate cutting-edge, 21st century treatments.
Consider just one stark statistic: Today, nine out of 10 compounds developed in the lab fail in human studies. They fail, in large part because they behave differently in people than they did in animal or laboratory tests.
The initiative we are here to discuss is one of many we at FDA are implementing that will remove some of the hurdles from the earliest phases of drug testing and medical development in people, so that researchers can more rapidly establish whether or not a new compound truly has a real clinical benefit for people. This is about saving lives — and building medicine’s future.
As I began, I defined and described the effort — to bring all of the fruits of scientific discovery to the point where they are actually impacting on people’s lives and improving those lives and saving those lives — as a process. There are many steps along that process where we believe FDA can make a very important and significant contribution. This is just one of them: one of them in the process of the development of a drug through a clinical trial process.
Science is rapidly coming to understandings of the genetic and molecular mechanisms of not just a disease like cancer, but diabetes, cardiovascular disease, and on and on. As that rapid scientific discovery is occurring, the FDA is committed to facilitating the rapid translation and the development of that knowledge into the development of new drugs or treatments that are going to alleviate those diseases.
But rapid does not mean reckless. There is no compromise in the rigor of the clinical trials process, no compromise in the rigor of laboratory testing and animal testing, or on the standards that will be applied.
But as researchers are using modern tools for discovery, we believe that we can use those modern tools in the development process, as well, and gain these insights that will enable us to make critical decisions as to what should go forward — because it has great hope and promise and can be quite effective — and what should not.
This process is not only about defining and describing the efficacy or effectiveness of interventions. In fact, these tools at the molecular level can also give us insights into the safety of these medications. Other initiatives that are included in the Critical Path, for example, are efforts to find biomarkers that will enable us, in these early kinds of testing studies, to pick up the clues that will tell us about toxicity, as well as effectiveness.
So I hope today that you will take away a glimpse of one initiative, with a couple of components that we believe are important, major steps. You’ve heard from people who are actually in the trenches, doing the work, who reflect the fact that this is something that will be a major contribution. I also hope you will take away from this conversation the realization that it is just one part and one piece of a process. We’re committed to that process. We’re committed to maintaining the gold standard that the FDA has always established and created, that we will continue to make certain that the patients and the people who are depending on us get the most effective, safest interventions possible.
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