Hearing of the Health Subcommittee of the House Energy and Commerce Committee - 21st Century Cures: Modernizing Clinical Trials

Hearing

The topic of this hearing is an important one. Clinical trials form the bedrock of modern medical product development. We rely on clinical trials to demonstrate that our drugs and devices are safe and effective. And we rely on the willingness of people to volunteer to participate in these trials.

So of course, we want to ensure that clinical trials are conducted using the most modern tools and technology that science has to offer.

We also need to ensure that clinical trials are conducted in the most efficient manner
possible. That is why NIH and FDA have been leaders in working with academia and industry to identify areas in which the clinical trial process can be improved. These improvements could include encouraging the use of centralized Institutional Review Boards, developing standards for harmonizing the collection and exchange of data, and maintenance of patient registries to facilitate the recruitment of patients for clinical trials. I look forward to hearing more today about such efforts.

How Congress can help advance those goals is a complicated question. The 21st
Century Cures initiative is useful because it is shining a light on some important issues surrounding how drugs and devices are developed and ultimately delivered to patients.

There are some clear areas where Congress could legislate. We should ensure that both FDA and NIH have the resources they need to remain the gold standard in overseeing clinical trials.

But when it comes to legislating how clinical trials are conducted, we need to proceed
with great caution. Congress should not be in the business of dictating the kind or level of evidence needed to permit drugs and devices to go on the market. That decision is solely the task of the scientific experts at FDA. We should not force FDA to prematurely accept novel technologies. Our job should be to ensure that FDA has the regulatory authority needed to make use of the latest scientific advances.

When FDA does testify on Friday, the agency can tell us about how it is applying novel approaches to clinical trials in their regulation of drugs and devices. I would also like to know whether the agency believes it has the authorities necessary to adopt new approaches and whether other new statutory powers are necessary.

In this area, we need to be careful not to try to fix things that are not broken. That could harm a system that is already working very well. We should create policies that foster scientific advances, but we should not enact regulatory policies based on how far we wish scientific development has progressed.

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