[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66543-66545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3579]


Using Technologies and Innovative Methods To Conduct Food and 
Drug Administration-Regulated Clinical Investigations of 
Investigational Drugs; Establishment of a Public Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of 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 seeks 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.

DATES: Submit electronic or written comments by December 28, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-3579 for ``Using Technologies and Innovative Methods to 
Conduct FDA-Regulated Clinical Investigations of Investigational 
Drugs.'' Please identify the specific question or issue that the 
comment addresses. Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 66544]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nicole Silva, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3341, Silver Spring, MD 20993-0002, 301-
796-3419; Aaliyah K. Eaves, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, Silver Spring, MD 20993-0002, 301-796-2948; or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Clinical investigations that ensure the protection of the rights, 
safety, and welfare of trial participants and that yield reliable data 
are critical to FDA's mission to ensure that medical products are safe 
and effective. The clinical trial enterprise continues to evolve and 
become more complex, and the scientific and infrastructure challenges 
of conducting clinical investigations affect the cost and timeliness of 
medical product development. 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. 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. In addition to potential convenience for the trial 
participant, 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. This may enhance the sponsor's 
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.
    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. Use of these 
technologies and methods allows for more flexibility for the sponsor 
and clinical investigator in the oversight of clinical investigation 
conduct, data collection, and monitoring of trial participants and 
clinical sites. Other elements that may be incorporated into clinical 
investigations to improve trial participant recruitment include online/
Web-based eligibility screening, informed consent, and communication 
between investigators and participants.

II. Purpose of the Docket

    FDA is soliciting public input from a broad group of stakeholders 
regarding technologies and innovative methods for using technology to 
more efficiently conduct clinical research. FDA is interested in 
identifying 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.

III. Issues for Comment

    In addition to the general information requests in section II of 
this document, FDA is interested in obtaining information and public 
comment on the following specific issues:
    1. 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.
    2. What are ways FDA could encourage adoption of these technologies 
and innovative methods in the conduct of clinical investigations?
    3. 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.
    a. 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?
    b. 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?
    4. 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

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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.
    a. Are there specific patient groups or therapeutic areas that 
could particularly benefit from these types of technologies or methods?
    b. What new opportunities for the conduct of clinical 
investigations are created through the use of continuous or 
intermittent remote monitoring and data collection?
    c. 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?
    d. 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?
    e. 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?
    f. Are there unique considerations for ensuring integrity of the 
source data, for example, authenticity and reliability?
    g. How should validation of participant-operated mobile devices be 
addressed?
    h. 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?
    i. 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?

    Dated: October 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27581 Filed 10-28-15; 8:45 am]
 BILLING CODE 4164-01-P