FDA looks to improve its use of IT for clinical investigations

The U.S. Food and Drug Administration, attempting to improve its clinical investigation processes, established a public docket last week to solicit feedback on how healthcare stakeholders are using technology for such research efforts.

Announced in the Federal Register Oct. 29, the FDA seeks to address concerns around both "scientific" and "infrastructure" challenges associated with conducting clinical research.

"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," the agency says. For instance, it notes, technology enables participants to overcome potential "geographic and logistical barriers," which could lead to more "meaningful data" being obtained.

The FDA aims to answer several questions, including:

  • What technologies, communication infrastructure or innovative methods are being used to conduct clinical investigations?
  • What are ways the FDA could encourage adoption of these technologies and innovative methods in the conduct of clinical investigations?
  • What challenges do stakeholders anticipate in adoption of these technologies or methods? And what are the perceived barriers or challenges to obtaining and documenting informed consent or institutional review board review, approval and oversight for clinical investigations?

The FDA also wants to get an idea for how potential trial participants will react to the use of new technologies or investigations in "nontraditional settings" and in bring-your-own-device (BYOD) scenarios, and if there are challenges associated with the authenticity and reliability of information obtained via BYOD.

"What are the perceived barriers to pooling data collected from different devices provided by individual trial participants, as well as pooling data from the BYOD model with data collected at the investigational site or on paper forms?" the agency asks. "How should situations such as mid-study user device switches be handled?"

In July, Los Angeles-based Cedars-Sinai Medical Center announced that its Research for Her online registry that matches women with research studies and clinical trials is 27 percent quicker than traditional paper-based registries.

A study published in May by Johns Hopkins University concluded that poor data monitoring and reporting via the use of "substandard" clinical registries negatively impacts patient treatment selection, health policy development and hospital performance evaluation effort. Marty Makary, a professor of surgery at the school and the study's lead investigator, referred to the current state of online clinical registries as the Wild West, calling most "underdeveloped, underfunded," and not scientifically sound.

To learn more:
- here's the FDA announcement in the Federal Register