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Lengthy Clinical Trial Process Gets Overhaul by FDA


Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities.

The other two goals focus on 1) striking a better balance between data collection requirements and the time it takes to review a medical device and 2) excelling at customer service.

“At the Center for Devices and Radiological Health, clinical trials are the foundation for our decisions to approve the most important medical devices – products that have the potential to save or sustain life, but that also present the greatest risk to patients,” reads an FDAVoice blog titled “A CDRH Priority: Clinical Trials in the U.S.” “Over the past year, we saw several exciting new medical devices reach U.S. patients… None of these products would have come to market without clinical trials.”

But the clinical trial process can be laborious – and lengthy. Before any work can be done, an application for an Investigational Device Exemption must be filed with the agency. The application is considered by the staff, which reviews the information about the device at hand for potential risks to those who will be participating in the trial. The goal is to speed up the system.

Medical research in 1912 was just as important as it is now.

Medical research in 1912 was just as important as it is now.

“Just a few years ago, it was… not uncommon for a year or more to pass before FDA could grant approval to a medical device developer to begin the trial,” according to FDAVoice. “This type of delay was one factor that led developers to seek approval in other countries. Over the past year, CDRH has taken a number of actions to expedite the safe initiation of clinical trials in the U.S., and we believe these policies will result in conducting clinical studies in the U.S. earlier in the device development process than was the case in the past.”

It is worth noting the FDA frequently is encouraged by lawmakers to fast-track approval of new devices, as well as drugs, in an effort to spur the economy. But the mission of the CDRH remains “to protect and promote the public health… assuring consumer confidence in devices marketed in the U.S.”

Through the establishment of the Clinical Trials Program, which is run by the Office of Device Evaluation, there is more interaction than ever between the agency and the maker of the device. The program emphasizes not only communication but also training and has resulted in two main guidance documents, one titled “FDA Decisions for Investigational Device Exemption Clinical Investigations” and another, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.”

Because of the program, the FDA reports, the number of days it takes to issue IDE approval has decreased to 101, from 442 – almost an entire year.

“We are committed to making U.S. patients the first in the world to have access to safe and effective medical devices,” according to FDAVoice. “And we’ve taken the first step to that, by helping ensure that clinical trials take place here, in the U.S.”

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