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Compliance In Focus
Posted by John Lehmann on Wed, Feb 20, 2013

The Safest Way to Test Medical Devices?

Without the willing volunteers to give their consent and participate in clinical research trials manyThe Safest Way to Test Medical Devices innovative medical devices and life-saving pharmaceutical drugs would never reach patients. FDA and other regulatory bodies exist to protect the rights, welfare, and safety of those subjects choosing to contribute to a study. However, is there an even better way to bring these products to market that would require zero percent risk to human subjects?

The Wall Street Journal published an article, “Scientists Find Safer Ways To Test Medical Procedures” which takes a look at using “virtual patients” to study end points and medical procedures that may not be readily tested in human subjects.

 For example, the article speaks to certain procedures concerning pregnant women. In current medical practice pregnant women are excluded from participating in some clinical research trials and rarely undergo certain medical procedures. However, could a virtual patient give researchers a better understanding of how certain procedures effect the fetus?   The article pointed out that “researchers recently tested the new software, called VirtualDose, in a simulation of an abdominal CT scan of a woman in her sixth month of pregnancy. They found that although the fetus did absorb radiation, the dose was 40% less than that calculated by a more rudimentary software tool that is currently in use.”

What potential benefits exist beyond patient protection and break through data? According to the article, “Virtual patients could allow medical-device companies to test new products earlier, helping the devices get to market more quickly and cheaply, according to the Food and Drug Administration.” Perhaps virtual patients will:

  • Allow quick bench to bedside timelines
  • Allow for increased statistical analysis of data
  • More data from virtual patients of vulnerable populations
  • Increased patient protection

Could virtual patients be the future of clinical research?  “The research mimics a clinical trial, but can be performed more quickly and without risk to real patients, says Kyle Myers, director of the Division of Imaging and Applied Mathematics at the FDA division. She says researchers hope in the future to use the techniques to investigate potential treatments.”

Do you believe the same trial endpoints can be met with software and algorithms? Let us know what you think below.

Photo Credit: Damon Sacks

Product Accountability in Clinical Trials



Topics: Medical Devices, Testing, Virtual Patients, FDA


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