Notice2024-21078
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availability
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Published
September 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, investigators, and other interested parties entitled "Conducting Clinical Trials With Decentralized Elements." This guidance provides recommendations regarding the implementation of decentralized elements in clinical trials for drugs, biological products, and devices. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants (e.g., telehealth visits with investigators or visits with local healthcare providers (HCPs)). FDA's regulatory requirements are the same for trials that include decentralized elements and trials that do not include decentralized elements. To help ensure the appropriate oversight trials with decentralized elements, the integrity of trial data, and the safety of trial participants, this guidance covers the responsibilities of sponsors and investigators. This guidance finalizes the draft guidance entitled "Decentralized Clinical Trials for Drugs, Biological Products, and Devices" issued on May 3, 2023.
Full Text
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<title>Federal Register, Volume 89 Issue 181 (Wednesday, September 18, 2024)</title>
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[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Pages 76481-76482]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21078]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-2870]
Conducting Clinical Trials With Decentralized Elements; Guidance
for Industry, Investigators, and Other Interested Parties Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry, investigators, and
other interested parties entitled ``Conducting Clinical Trials With
Decentralized Elements.'' This guidance provides recommendations
regarding the implementation of decentralized elements in clinical
trials for drugs, biological products, and devices. Decentralized
elements allow trial-related activities to occur remotely at locations
convenient for trial participants (e.g., telehealth visits with
investigators or visits with local healthcare providers (HCPs)). FDA's
regulatory requirements are the same for trials that include
decentralized elements and trials that do not include decentralized
elements. To help ensure the appropriate oversight trials with
decentralized elements, the integrity of trial data, and the safety of
trial participants, this guidance covers the responsibilities of
sponsors and investigators. This guidance finalizes the draft guidance
entitled ``Decentralized Clinical Trials for Drugs, Biological
Products, and Devices'' issued on May 3, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on September 18, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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-2022-D-2870 for ``Conducting Clinical Trials With Decentralized
Elements.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ryan Robinson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3342, Silver Spring, MD 20993, 240-402-
9756; James Myers, Center for Biologics Evaluation and Research, Food
and
[[Page 76482]]
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911; Soma Kalb, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. G318, Silver Spring, MD 20993-0002,
301-796-6359; or Paul Kluetz, Oncology Center of Excellence, Food and
Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 2223,
Silver Spring, MD 20993, 301-796-9567.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Conducting Clinical Trials With Decentralized Elements.''
Section 3606(a) of the Consolidated Appropriations Act, 2023 directs
FDA to issue a final guidance that includes recommendations to clarify
and advance the use of DCTs to support the development of drugs and
devices. This guidance fulfills the requirements set forth in section
3606(a)(2) of the Consolidated Appropriations Act, 2023. The content
described in section 3606(b) of the Consolidated Appropriations Act,
2023 is further addressed through this guidance's reference to FDA's
guidance for industry, investigators, and other stakeholders entitled
``Digital Health Technologies for Remote Data Acquisition in Clinical
Investigations'' (December 2023).
In this guidance, a decentralized clinical trial (DCT) refers to a
clinical trial that includes decentralized elements where trial-related
activities occur at locations other than traditional clinical trial
sites. These trial-related activities may take place at the location of
trial participants (e.g., their homes) or in local healthcare
facilities that are close to trial participants' locations. FDA's
regulatory requirements are the same for trials that include
decentralized elements and trials that do not include decentralized
elements.
DCTs may include the use of local healthcare providers and local
clinical laboratory facilities in the management of trial participants
and the use of telehealth and digital health technologies to acquire
data remotely. By allowing remote participation and reducing the need
to travel for face-to-face visits, DCTs may enhance convenience for
study participants, facilitate research on diseases affecting
populations with limited mobility, and reduce the burden on caregivers.
This guidance provides recommendations related to the incorporation
of decentralized elements into clinical trials, including: (1) DCT
design, conduct, and oversight; (2) conduct of remote clinical trial
visits and activities including the use of local HCPs; (3) use of
digital health technologies in DCTs; (4) the roles of sponsors and
investigators in DCTs; (5) informed consent and institutional review
board oversight of DCTs; (6) types of investigational products
appropriate for study in DCTs; (7) packaging and shipping of
investigational products in DCTs; (8) processes and procedures to
ensure participant safety; and (9) use of software in DCTs.
This guidance finalizes the draft guidance entitled ``Decentralized
Clinical Trials for Drugs, Biological Products, and Devices'' issued on
May 3, 2023 (88 FR 27900). FDA considered comments received on the
draft guidance as the guidance was finalized. Changes from the draft to
the final guidance include: (1) removal of language regarding the
requirement to maintain a task log of local HCPs, (2) clarification
about challenges related to data variability in DCTs, (3) updates to
responsibilities for ensuring qualifications of local HCPs, and (4)
clarifications on the need for a physical location for inspections. In
addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Conducting Clinical Trials With
Decentralized Elements.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21
CFR part 11 pertaining to electronic records and signatures have been
approved under OMB control number 0910-0303. The collections of
information in 21 CFR part 312 pertaining to investigational new drug
applications, including Form FDA 1572, have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR part
812 pertaining to investigational device exemption applications have
been approved under OMB control number 0910-0078. The collections of
information in 21 CFR parts 50 and 56 pertaining to the protection of
human subjects, informed consent, and institutional review boards have
been approved under OMB control number 0910-0130.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21078 Filed 9-17-24; 8:45 am]
BILLING CODE 4164-01-P
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