[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41990-41992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14995]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-0363]
Cancer Clinical Trial Eligibility Criteria: Patients With Human
Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus
Infections; 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 ``Cancer
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B
Virus, or Hepatitis C Virus Infections.'' This guidance is one in a
series of guidances that provide recommendations regarding eligibility
criteria for clinical trials of drugs or biological products 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 guidance includes recommendations on the
inclusion of patients with human immunodeficiency virus (HIV),
hepatitis B virus (HBV) infections, and hepatitis C virus (HCV)
infections. Exclusion of patients with HIV, HBV, or HCV infections from
cancer clinical trials remains common in most studies of
investigational drugs. Expanding cancer clinical trial eligibility to
be more inclusive of patients with HIV, HBV, or HCV infections is
justified in many cases and may accelerate the development of effective
therapies in cancer patients with these chronic infections. This
guidance finalizes the draft guidance of the same title that published
on March 13, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on July 13, 2020.
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:
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
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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-2019-D-0363 for ``Cancer Clinical Trial Eligibility Criteria:
Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus
Infections.'' 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 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; 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with
HIV, Hepatitis B Virus, or Hepatitis C Virus Infections.'' This
guidance provides recommendations on the inclusion of patients with
HIV, HBV, and HCV infections in clinical trials of drugs or biological
products regulated by CDER and CBER for the treatment of cancer.
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. However, some eligibility criteria have become commonly accepted
over time or used as a template across trials without clear scientific
or clinical rationale. 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. Broadening
cancer trial eligibility criteria can maximize the generalizability of
trial results and the ability to understand the therapy's benefit-risk
profile across the patient population likely to use the drug in
clinical practice and should be considered to avoid jeopardizing
patient safety.
The guidance recommends that eligibility criteria regarding
patients with HIV, HBV, or HCV infections address requirements
regarding relevant concurrent antiviral and other therapies (e.g.,
antibiotic prophylaxis) and degree of immunocompetence appropriate for
a given cancer, investigational drug, and intended use population. The
recommendations for eligibility criteria for patients with cancer and
concurrent HIV infection are focused on evaluation of immune function
and HIV therapy. The recommendations for eligibility criteria for
cancer patients with evidence of chronic HBV or with history of chronic
HCV or virologically suppressed on HCV treatment are focused on liver-
related laboratories and HBV/HCV therapy.
In the Federal Register of March 13, 2019 (84 FR 9130), FDA
announced the availability of the draft guidance of the same title. FDA
received comments and considered those comments as the guidance was
finalized. The final guidance includes additional detail on the
recommendations regarding
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eligibility criteria related to HBV and HCV therapy, additional
references in the appendices for patients with HBV and HCV in cancer
trials, and clarifications.
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 ``Cancer Clinical Trial Eligibility
Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus
Infections.'' 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
This guidance refers to previously approved FDA collections of
information. These 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 312 have been approved under OMB control number 0910-0014; 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
either 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, or https://www.regulations.gov.
Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14995 Filed 7-10-20; 8:45 am]
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