FDA Seeks Comments on the Use of Technologies in Clinical Research

Apr 05, 2016

Post by Adam Curran
fda seeks

The US Food and Drug Administration (FDA) has recently announced a request for comments on the scope and direction of use of technologies and other innovative methods in clinical research. The US agency is seeking feedback specifically around the use of such technologies to conduct more efficient clinical trials, and also information as to the possible barriers with implementing these technologies. Recognizing that technology used in conducting clinical research has greatly emerged over the last decade, the FDA is now asking for public input around technologies and methods such as mobile health technology (mHealth), telemedicine and the use of remote sensors.

Bring Your Own Device (BYOD) is an integral part of mobile health technology use in clinical trials. With over 7 billion people in the world today, and almost 3 billion of them with some type of smartphone, mobile PC or tablet, BYOD is a pivotal technology for the future of clinical research.

Sure there are currently barriers that exist, such as regulatory concerns around the controls and source documentation related to data collected on an electronic device, or questions about validation of various mobile instruments with varying screen sizes and multiple operating systems, and the need to ensure that patient data collected from one type of device is comparable to data collected from a totally different device. However, these barriers can be addressed and overcome, and now is our chance to provide this type of evidence to the FDA by providing additional information to support positive conclusions of BYOD use in clinical studies.

Now is the time for technology vendors, sponsors, CROs, and other industry leaders to come together and provide the information that the FDA is seeking in order to gain approval and acceptance of technologies and methods, such as BYOD or other mHealth technologies, telemedicine and remote sensors to be used in clinical research conduct.

Comments will be accepted by the FDA, either electronically or written, through December 28, 2015. Full information on the establishment of this public docket for comments can be found here: https://www.federalregister.gov/articles/2015/10/29/2015-27581/using-technologies-and-innovative-methods-to-conduct-food-and-drug-administration-regulated-clinical

Interested in learning more about BYOD? Click here to download a whitepaper on the many reasons, as well as some of the challenges, that are making BYOD a reality for electronic patient-reported outcomes (ePRO) and electronic clinical outcome assessment (eCOA).