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FDA Seeks Input on Use of IT for Clinical Investigations

November 4, 2015
by Heather Landi
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The U.S. Food and Drug Administration created a public docket last week to solicit feedback on how healthcare stakeholders are using technology for clinical research in order to improve its clinical investigations.

Announced in the Federal Register, the FDA also seeks stakeholder perspectives on possible barriers to implementing those technologies and methods to conduct clinical investigations.

“Creative uses of technology in conducting clinical investigations have emerged over the previous decade and include advances that have the potential to improve recruitment, participation, and retention of trial participants. New technology and communication infrastructure allow for collection of data and communication wherever the trial participant is located, including at his or her health care provider's location, creating opportunities to overcome geographical and logistical barriers that otherwise might prevent a potential trial participant from participating in a clinical investigation, as well as facilitating the integration of research with clinical care,” the FDA stated.

“Some of these technologies and methods may be used regardless of the trial participant's location and may include, for example, mobile health technology, telemedicine, and remote sensors,” the agency said.

The agency is requesting input in order to identify new opportunities to study medical products, as well as receiving comments on barriers, challenges, and relevant considerations that may affect a medical product clinical investigation that uses these technologies and methods.

The FDA also wants comments on specific issues, such as the technologies, communication infrastructure or innovative methods being used to conduct clinical investigations, ways FDA could encourage adoption of these technologies and innovative methods and the perceived clinical, cultural, business and regulatory barriers that serve as a disincentive to the use of technology to facilitate the conduct of clinical investigations.

The FDA also is interested in stakeholder feedback with regard to trial participants’ interest, concerns and willingness to participate in clinical investigations that involve nontraditional settings or utilize new technologies, such as when data is collected via Bring Your Own Device (BYOD) method.

Electronic or written comments must be submitted by Dec. 28 and can be submitted electronically the Federal eRulemaking Portal.


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