Notice2024-09038
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
Primary source
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Published
April 26, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the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 Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions.
Full Text
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<title>Federal Register, Volume 89 Issue 82 (Friday, April 26, 2024)</title>
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[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32440-32441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09038]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-1376]
Cancer Clinical Trial Eligibility Criteria: Washout Periods and
Concomitant Medications; Draft Guidance for Industry, Institutional
Review Boards, and Clinical Investigators; 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the availability of a draft guidance for industry, institutional review
boards (IRBs), and clinical investigators entitled ``Cancer Clinical
Trial Eligibility Criteria: Washout Periods and Concomitant
Medications.'' This draft guidance is one in a series of guidances that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
Research (CBER) for the treatment of cancer. Specifically, this draft
guidance includes recommendations regarding the appropriate use of
washout periods and concomitant medication exclusions.
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:
<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-2024-D-1376 for ``Cancer Clinical Trial Eligibility Criteria:
Washout Periods and Concomitant Medications.'' 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 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: Jamie Brewer, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2319, Silver Spring, MD 20993, 240-402-
4463; or Vishal Bhatnagar, Oncology Center of Excellence, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2113, Silver
Spring, MD 20993, 240-402-3696; 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.
[[Page 32441]]
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: Washout Periods and Concomitant
Medications.'' 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. Specifically,
this draft guidance includes recommendations regarding the appropriate
use of washout periods and concomitant medication exclusions 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 provide a more
detailed characterization of the therapy's benefit-risk profile across
the patient population 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: Washout Periods and Concomitant
Medications.'' 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 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/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>,
<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: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09038 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P
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