[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Notices]
[Pages 9129-9130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0359]


Cancer Clinical Trial Eligibility Criteria: Patients With Organ 
Dysfunction or Prior or Concurrent Malignancies; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Cancer 
Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or 
Prior or Concurrent Malignancies.'' This draft guidance is one in a 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 organ dysfunction or with prior or 
concurrent malignancies. 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 without 
jeopardizing patient safety.

DATES: Submit either electronic or written comments on the draft 
guidance by May 13, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-2019-D-0359 for ``Cancer Clinical Trial Eligibility Criteria: 
Patients with Organ Dysfunction or Prior or Concurrent Malignancies.'' 
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.gpo.gov/fdsys/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.
    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 Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002; or the Division of Drug Information, Center for Drug Evaluation 
and Research (CDER),

[[Page 9130]]

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. The draft guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: 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; or 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with 
Organ Dysfunction or Prior or Concurrent Malignancies.'' This draft 
guidance provides recommendations on the inclusion of patients with 
organ dysfunction or prior or concurrent malignancies in clinical 
trials of drugs or biological products regulated by CDER and CBER for 
the treatment of cancer.
    A clinical trial's eligibility criteria are essential components of 
the trial, defining the characteristics of the study population. 
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, 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 
without jeopardizing patient safety.
    The recommendations in this guidance for clinical trial eligibility 
criteria for patients with organ dysfunction focus on renal function, 
cardiac function, and hepatic function. This guidance also includes 
recommendations for eligibility criteria for patients with cancer who 
have a history of prior or concurrent second primary malignancies.
    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: Patients with Organ Dysfunction or 
Prior or Concurrent Malignancies.'' 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. This guidance is not subject to Executive 
Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). 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 draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: March 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04573 Filed 3-12-19; 8:45 am]
 BILLING CODE 4164-01-P