Cancer Clinical Trial Eligibility Criteria: Performance Status; Draft Guidance for Industry, Institutional Review Boards, Clinical Investigators; Availability, 32442-32444 [2024-09037]
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
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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
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Written/Paper Submissions
Submit written/paper submissions as
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• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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• For written/paper comments
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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–
2023–D–5303 for ‘‘Recommendations
for Collecting Representative Samples
for Food Testing Used as Evidence for
Release of Certain Fish and Fishery
Products Subject to Detention Without
Physical Examination and Removal of a
Foreign Manufacturer’s Goods From
Detention Without Physical
Examination; Draft Guidance for
Industry.’’ 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.
• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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://
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
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-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
Steven Bloodgood, Division of Seafood
Safety (HFS–325), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–5316,
email: Steven.Bloodgood@fda.hhs.gov;
or Holli Kubicki, Center for Food Safety
and Applied Nutrition, Office of
Regulations and Policy (HFS–024), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2378.
SUPPLEMENTARY INFORMATION: In the
Federal Register of February 12, 2024
(89 FR 9852), the Food and Drug
Administration (FDA or we) published
a notice announcing the availability of
a draft guidance for industry entitled
‘‘Recommendations for Collecting
Representative Samples for Food
Testing Used as Evidence for Release of
Certain Fish and Fishery Products
Subject to Detention Without Physical
Examination and Removal of a Foreign
Manufacturer’s Goods From Detention
Without Physical Examination; Draft
Guidance for Industry.’’ We provided a
60-day comment period for the draft
guidance.
We have received a request for a 60day extension of the comment period for
the draft guidance to provide additional
time to review and comment on the
rationale for the sampling
recommendations in the draft guidance.
In the interest of balancing the public
health importance of the sampling
recommendations in the draft guidance
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
and granting additional time to submit
comments before we finalize the draft
guidance, we have concluded that it is
reasonable to reopen the comment
period for 60 days, until June 25, 2024.
We are reopening the comment period
because the request for an extension of
the comment period arrived too late for
us to extend the comment period. We
believe that an additional 60 days
allows adequate time for interested
persons to submit comments.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08952 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1377]
Cancer Clinical Trial Eligibility Criteria:
Performance Status; Draft Guidance
for Industry, Institutional Review
Boards, Clinical Investigators;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry, institutional
review boards (IRBs), and clinical
investigators entitled ‘‘Cancer Clinical
Trial Eligibility Criteria: Performance
Status.’’ This draft guidance is one in a
series of guidances that provide
recommendations regarding eligibility
criteria for clinical trials of
investigational drugs regulated by the
Center for Drug Evaluation and Research
(CDER) and the Center for Biologics
Evaluation and Research (CBER) for the
treatment of cancer. Specifically, this
draft guidance includes
recommendations regarding expanding
eligibility criteria to include patients
with a wider range of performance
status.
DATES: Submit either electronic or
written comments on the draft guidance
by June 25, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\26APN1.SGM
26APN1
Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
• 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• 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–
2024–D–1377 for ‘‘Cancer Clinical Trial
Eligibility Criteria: Performance Status.’’
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.
• 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
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
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-201509-18/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 the draft 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, or to 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. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Paul
Kluetz, Oncology Center of Excellence,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm.
2223, Silver Spring, MD 20993, 301–
796–9567; or Harpreet Singh, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2137,
Silver Spring, MD 20993, 240–402–
3561; or James Myers, Center for
Biologics Evaluation and Research,
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
32443
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry, IRBs, and
clinical investigators entitled ‘‘Cancer
Clinical Trial Eligibility Criteria:
Performance Status.’’ The purposes of
eligibility criteria are to select the
intended patient population and reduce
potential risks to trial participants.
However, eligibility criteria are
sometimes more restrictive than
necessary, and expanding eligibility
criteria to be more inclusive is one trial
design consideration that may improve
the diversity of clinical trial
populations. This draft guidance is one
in a series of guidances that provide
recommendations regarding eligibility
criteria for clinical trials of
investigational drugs regulated by CDER
and CBER for the treatment of cancer.
This draft guidance includes
recommendations regarding expanding
eligibility criteria to include patients
with a wider range of performance
status, and is intended to assist
interested parties, including sponsors
and IRBs, who are responsible for the
development and oversight of clinical
trials.
A clinical trial’s eligibility criteria (for
inclusion and exclusion) are essential
components of the trial, defining the
characteristics of the study population.
Because there is variability in
investigational drugs and trial
objectives, eligibility criteria should be
developed taking into consideration the
mechanism of action of the drug, the
targeted disease or patient population,
the anticipated safety of the
investigational drug, the availability of
adequate safety data, and the ability to
recruit trial participants from the patient
population to meet the objectives of the
clinical trial. The Agency recognizes
that some eligibility criteria may have
become commonly accepted over time
or used as a template across trials, but
such criteria should be carefully
considered and be appropriate for a
specific trial context. Unnecessarily
restrictive eligibility criteria may slow
patient accrual, limit patients’ access to
clinical trials, and lead to trial results
that do not fully represent treatment
effects in the patient population that
will ultimately use the drug.
Appropriately broadening cancer trial
eligibility criteria can improve the
generalizability of trial results and
characterize the therapy’s benefit-risk
profile across the patient population
E:\FR\FM\26APN1.SGM
26APN1
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
likely to use the drug in clinical
practice.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Cancer Clinical Trial Eligibility
Criteria: Performance Status.’’ 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 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 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; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09037 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2024–N–1592]
Promoting Effective Drug
Development: Identifying
Opportunities and Priorities for the
Food and Drug Administration’s Office
of Clinical Pharmacology; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket entitled
‘‘Promoting Effective Drug
Development: Identifying Opportunities
and Priorities for the Food and Drug
Administration’s Office of Clinical
Pharmacology.’’ The purpose of this
docket is to solicit input from interested
parties on specific and actionable policy
topics that could be prioritized,
developed, and implemented by the
staff of the Center for Drug Evaluation
and Research’s (CDER’s) Office of
Clinical Pharmacology (OCP) to support
effective drug development programs.
DATES: Although you can comment at
any time, to ensure that the Agency
considers your comment, submit either
electronic or written comments by June
25, 2024.
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
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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–
2024–N–1592 for ‘‘Promoting Effective
Drug Development: Identifying
Opportunities and Priorities for the
Food and Drug Administration’s Office
of Clinical Pharmacology.’’ 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.
• 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-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
Anuradha Ramamoorthy, Office of
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32442-32444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09037]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1377]
Cancer Clinical Trial Eligibility Criteria: Performance Status;
Draft Guidance for Industry, Institutional Review Boards, Clinical
Investigators; 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 draft guidance for industry, institutional review
boards (IRBs), and clinical investigators entitled ``Cancer Clinical
Trial Eligibility Criteria: Performance Status.'' This draft guidance
is one in a series of guidances that provide recommendations regarding
eligibility criteria for clinical trials of investigational drugs
regulated by the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) for the treatment
of cancer. Specifically, this draft guidance includes recommendations
regarding expanding eligibility criteria to include patients with a
wider range of performance status.
DATES: Submit either electronic or written comments on the draft
guidance by June 25, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
[[Page 32443]]
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
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-2024-D-1377 for ``Cancer Clinical Trial Eligibility Criteria:
Performance Status.'' 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.
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 the draft 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, or to 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. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Paul Kluetz, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2223, Silver Spring, MD 20993, 301-796-9567; or Harpreet
Singh, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2137, Silver
Spring, MD 20993, 240-402-3561; or James Myers, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for
industry, IRBs, and clinical investigators entitled ``Cancer Clinical
Trial Eligibility Criteria: Performance Status.'' The purposes of
eligibility criteria are to select the intended patient population and
reduce potential risks to trial participants. However, eligibility
criteria are sometimes more restrictive than necessary, and expanding
eligibility criteria to be more inclusive is one trial design
consideration that may improve the diversity of clinical trial
populations. This draft guidance is one in a series of guidances that
provide recommendations regarding eligibility criteria for clinical
trials of investigational drugs regulated by CDER and CBER for the
treatment of cancer. This draft guidance includes recommendations
regarding expanding eligibility criteria to include patients with a
wider range of performance status, and is intended to assist interested
parties, including sponsors and IRBs, who are responsible for the
development and oversight of clinical trials.
A clinical trial's eligibility criteria (for inclusion and
exclusion) are essential components of the trial, defining the
characteristics of the study population. Because there is variability
in investigational drugs and trial objectives, eligibility criteria
should be developed taking into consideration the mechanism of action
of the drug, the targeted disease or patient population, the
anticipated safety of the investigational drug, the availability of
adequate safety data, and the ability to recruit trial participants
from the patient population to meet the objectives of the clinical
trial. The Agency recognizes that some eligibility criteria may have
become commonly accepted over time or used as a template across trials,
but such criteria should be carefully considered and be appropriate for
a specific trial context. Unnecessarily restrictive eligibility
criteria may slow patient accrual, limit patients' access to clinical
trials, and lead to trial results that do not fully represent treatment
effects in the patient population that will ultimately use the drug.
Appropriately broadening cancer trial eligibility criteria can
improve the generalizability of trial results and characterize the
therapy's benefit-risk profile across the patient population
[[Page 32444]]
likely to use the drug in clinical practice.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Cancer
Clinical Trial Eligibility Criteria: Performance Status.'' 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
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 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; and the collections of information in 21
CFR part 601 have been approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09037 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P
