[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11718-11719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04399]



[[Page 11718]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 This guidance finalizes the draft guidance of the same 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: 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.
    <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 https://www.regulations.gov 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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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