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November 23, 2015

Will FDA Incorporate mHealth into Clinical Trials

Digital Health Download

On October 29, 2015, FDA published a Federal Register notice to establish a public docket to solicit input from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations. Specifically, FDA is seeking "information to understand individual and industry experiences with the use of such technologies to more efficiently conduct clinical research. FDA also seeks stakeholder perspectives on possible barriers to implementing these technologies and methods to conduct clinical investigations."

Comments are due on or before December 28, 2015, Docket No. FDA-2015-N-3579.

FDA recognized that as the "clinical trial enterprise" has evolved, the agency and stakeholders have seen challenges "in recruiting and retaining sufficient numbers of trial participants to conduct an adequately powered investigation in a reasonable amount of time may contribute to the cost and complexity." However, FDA acknowledge that "[c]reative 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.

FDA explained that "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." FDA recognized that "these tools and technologies may present sponsors with the opportunity to capture data more frequently and efficiently than would be feasible if data collection were only conducted when the trial participant visited the study site." As a result, sponsors may have the enhanced "ability to understand the safety and effectiveness of drugs, biologics, and medical devices; increase additional meaningful data gathering; minimize missing data; and maximize trial participation and retention."

Accordingly, FDA is interested in obtaining information and public comment on the following specific issues:

  • What technologies, communication infrastructure, or innovative methods are being used to conduct clinical investigations? FDA is aware of several groups conducting and interested in conducting clinical investigations using mobile technology and remote methods for data collection. FDA requests feedback on experiences with implementing such methods or models (for example, lessons learned), as well as information supporting the use of any suggested technologies, methods, or models, including any characteristics that would make the technology more or less desirable for use in clinical trials.
  • What are ways FDA could encourage adoption of these technologies and innovative methods in the conduct of clinical investigations?
  • Identify any clinical, cultural, business, regulatory, or other barriers perceived by stakeholders that serve as a disincentive to the use of technology to facilitate the conduct of clinical investigations.
  • What challenges do stakeholders anticipate in adoption of these technologies or methods? Are there challenges in complying with regulatory requirements surrounding the conduct of clinical investigations that use such technologies or methods?
  • What are the perceived barriers or challenges to obtaining and documenting informed consent or obtaining institutional review board review, approval, and oversight for clinical investigations utilizing these technologies or methods?

FDA is interested in obtaining information on potential trial participant acceptance, privacy, and human subject protection issues that may occur as a result of the use of technologies and innovative methods for the conduct of clinical investigations. In particular, FDA is interested in assessing potential trial participants' interest, tolerance, concerns, and willingness to participate in clinical investigations that involve nontraditional settings or utilize new technologies. FDA is also interested in identifying the factors that affect trial participant awareness, acceptance, enrollment, and retention for these investigations.

  • Are there specific patient groups or therapeutic areas that could particularly benefit from these types of technologies or methods?
  • What new opportunities for the conduct of clinical investigations are created through the use of continuous or intermittent remote monitoring and data collection?
  • What are some of the anticipated risks to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations?
  • What are some of the anticipated benefits to trial participants that may occur as a result of the use of these technologies or off-site methods in clinical investigations?
  • Are there perceived challenges to participation in clinical investigations utilizing these types of technologies or methods because of concerns regarding inadvertent disclosure of trial participants' information or breach of privacy? Are there concerns relating to the integrity of data collection or encryption or the secure transmission of information?
  • Are there unique considerations for ensuring integrity of the source data, for example, authenticity and reliability?
  • How should validation of participant-operated mobile devices be addressed?
  • What are the challenges presented when data are collected using the Bring Your Own Device (BYOD) model? BYOD in clinical investigations refers to the practice of trial participants using their own devices, such as smartphones or tablets, for data collection. For example, participants in a clinical investigation may use their own computer devices to access and respond to study-related questionnaires. 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? How should situations such as mid-study user device switches be handled?
  • What are the challenges or special considerations with recruiting and/or retaining potential trial participants with low levels of computer literacy or individuals who may have limited or no access to mobile technologies, computer devices, or the Internet? How can these challenges or special considerations best be addressed?