Notice2022-04399
Inclusion of Older Adults in Cancer Clinical Trials; Guidance for Industry; Availability
Primary source
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Published
March 2, 2022
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 entitled "Inclusion of Older Adults in Cancer Clinical Trials." This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this final guidance, older adults are those age 65 years and older. The final guidance emphasizes the particular importance of including adults over age 75 years in cancer clinical trials. Specifically, this final guidance includes recommendations for including an adequate representation of older adults in cancer clinical trials to better enable evaluation of the benefit-risk profile of cancer drugs in this population. This guidance finalizes the draft guidance of the same title issued on March 6, 2020.
Full Text
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<title>Federal Register, Volume 87 Issue 41 (Wednesday, March 2, 2022)</title>
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[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11718-11719]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04399]
[[Page 11718]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-5572]
Inclusion of Older Adults in Cancer Clinical Trials; Guidance for
Industry; 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 entitled ``Inclusion
of Older Adults in Cancer Clinical Trials.'' This guidance provides
recommendations regarding the inclusion of older adult patients in
clinical trials of drugs for the treatment of cancer. For the purpose
of this final guidance, older adults are those age 65 years and older.
The final guidance emphasizes the particular importance of including
adults over age 75 years in cancer clinical trials. Specifically, this
final guidance includes recommendations for including an adequate
representation of older adults in cancer clinical trials to better
enable evaluation of the benefit-risk profile of cancer drugs in this
population. This guidance finalizes the draft guidance of the same
title issued on March 6, 2020.
DATES: The announcement of the guidance is published in the Federal
Register on March 2, 2022.
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-2019-D-5572 for ``Inclusion of Older Adults in Cancer Clinical
Trials.'' 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. 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: Bindu Kanapuru, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2119, Silver Spring, MD 20993-0002, 240
402-1279.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
entitled ``Inclusion of Older Adults in Cancer Clinical Trials.'' This
final guidance provides recommendations for stakeholders, including
sponsors and institutional review boards, responsible for the
development and oversight of clinical trials regarding the inclusion of
older adult patients (i.e., age 65 years and older) in clinical trials
of drugs for the treatment of cancer. The final guidance emphasizes the
particular importance of including adults over age 75 years in cancer
clinical trials.
Enrolling an adequate representation of the range of patients in a
clinical trial that may be exposed to a drug after approval can
maximize the generalizability of the trial results. It provides the
ability to understand the drug's benefit-risk profile across the
patient population likely to use the drug in clinical practice.
Including information in the labeling describing use in older adults
helps to promote the safe and effective use of these products and
better informs treatment decisions in clinical practice.
Older adults are underrepresented in cancer clinical trials despite
[[Page 11719]]
representing a growing segment of the population of cancer patients.
Therefore, more information is needed to better inform treatment
decisions for older adults with cancer. The issue persists in oncology
despite FDA's efforts to increase the inclusion of older adults in
clinical trials.
The guidance recommends that sponsors of cancer trials consider the
age demographics of their target population early in development and
that a strategy for inclusion of older adults be informed by any known
information for older adults. The final guidance includes
recommendations for inclusion of older adults related to early clinical
development; clinical trials, including considerations for trial
design, recruitment, and developing and reporting discrete age
subgroups; and the postmarket setting.
This guidance finalizes the draft guidance entitled ``Inclusion of
Older Adults in Cancer Clinical Trials'' issued on March 6, 2020 (85 FR
13167). FDA considered comments received on the draft guidance as the
guidance was finalized. Changes from the draft to the final guidance
include capture of comorbidity information, clarification that this
guidance applies to both small and large studies, added guidance on
decentralization and recruitment efforts for community oncologists, an
improved definition of adequate representation in a study trial,
clarification of trial design stratification, and added references to
other guidances.
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 ``Inclusion of Older Adults in Cancer
Clinical Trials.'' 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 601 have been approved under 0910-0338;
and the collections of information in 21 CFR 201.56 and 201.57 have
been approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04399 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P
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