Using Technologies and Innovative Methods To Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket, 66543-66545 [2015-27581]
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Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
66543
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
54.4(b)—Clinical Investigators ..........................................
1 There
Number of disclosures per
respondent
Number of
respondents
21 CFR Section
7,106
1
OMB control number 0910–0802. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
[FR Doc. 2015–27559 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–27558 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2013–D–0286]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Formal
Meetings Between the Food and Drug
Administration and Biosimilar
Biological Product Sponsors or
Applicants
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
7,106
Average burden
per disclosure
0.17
(10 minutes) .....
Total hours
1,208
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Formal
Meetings Between the Food and Drug
Administration and Biosimilar
Biological Product Sponsors or
Applicant’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On June
25, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on
Formal Meetings Between the Food and
Drug Administration and Biosimilar
Biological Product Sponsors or
Applicant’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Total annual
disclosures
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
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.
Notice; establishment of docket;
request for comments.
ACTION:
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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://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 https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
E:\FR\FM\29OCN1.SGM
29OCN1
66544
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
• 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
https://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: https://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 https://
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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:
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
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.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
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
E:\FR\FM\29OCN1.SGM
29OCN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices
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
VerDate Sep<11>2014
23:37 Oct 28, 2015
Jkt 238001
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]
66545
Dated: October 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27557 Filed 10–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Health Resources and Services
Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Statement of Organization, Functions
and Delegations of Authority
Food and Drug Administration
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 80 FR 44358 dated
July 27, 2015).
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
of Planning, Analysis, and Evaluation
(RA5). Specifically, this notice: (1)
Establishes the Office of Strategic
Initiatives (RA59) within the Office of
Planning, Analysis, and Evaluation.
[Docket No. FDA–2014–D–2138]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Adverse
Event Reporting for Outsourcing
Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Adverse
Event Reporting for Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug and Cosmetic Act’’
has been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On August
4, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on
Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0800. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Chapter RA5—Office of Planning,
Analysis, and Evaluation
Section RA5—00, Mission
The Office of Planning, Analysis, and
Evaluation (RA5) provide HRSA-wide
leadership on cross-agency initiatives
and Departmental priorities.
Section RA5–10, Organization
Delete the organization for the Office
of Planning, Analysis, and Evaluation in
its entirety and replace with the
following:
The Office of Planning, Analysis, and
Evaluation (RA5) is headed by the
Director, who reports directly to the
Administrator, Health Resources and
Services Administration. The Office of
Planning, Analysis, and Evaluation
includes the following components:
(1) Office of the Director (RA5);
(2) Office of Policy Analysis (RA53);
(3) Office of Research and Evaluation
(RA56);
(4) Office of External Engagement
(RA57);
(5) Office of Performance and Quality
Measurement (RA58); and
(6) Office of Strategic Initiatives
(RA59).
Section RA5–20, Functions
This notice reflects organizational
changes in the Health Resources and
Services Administration (HRSA), Office
E:\FR\FM\29OCN1.SGM
29OCN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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
[[Page 66545]]
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
