Notice2024-21077
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability
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Published
September 18, 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice." FDA is publishing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act to issue guidance about the use of RWE in regulatory decision-making. This draft guidance is intended to support the conduct of randomized controlled drug trials with streamlined protocols and procedures that can integrate research into routine clinical practice.
Full Text
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<title>Federal Register, Volume 89 Issue 181 (Wednesday, September 18, 2024)</title>
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[Federal Register Volume 89, Number 181 (Wednesday, September 18, 2024)]
[Notices]
[Pages 76482-76484]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21077]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-2052]
Integrating Randomized Controlled Trials for Drug and Biological
Products Into Routine Clinical Practice; Draft Guidance for Industry;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the availability of a draft guidance for industry entitled
``Integrating Randomized Controlled Trials for Drug and Biological
Products Into Routine Clinical Practice.'' FDA is publishing this draft
guidance as part of a series of guidance documents under its Real-World
Evidence (RWE) Program and to satisfy, in part, a mandate under the
Federal Food, Drug, and Cosmetic Act to issue guidance about the use of
RWE in regulatory decision-making. This draft guidance is intended to
support the conduct of randomized controlled drug trials with
streamlined protocols and procedures that can integrate research into
routine clinical practice.
DATES: Submit either electronic or written comments on the draft
guidance by December 17, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
[[Page 76483]]
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-2052 for ``Integrating Randomized Controlled Trials for Drug
and Biological Products Into Routine Clinical Practice.'' 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 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: Heather Stone, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3348, Silver Spring, MD 20993-0002, 301-
796-2274, <a href="/cdn-cgi/l/email-protection#733b1612071b16015d20071c1d16331517125d1b1b005d141c05"><span class="__cf_email__" data-cfemail="abe3cecadfc3ced985f8dfc4c5ceebcdcfca85c3c3d885ccc4dd">[email protected]</span></a>; or James Myers, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Integrating Randomized Controlled Trials for Drug and
Biological Products Into Routine Clinical Practice.'' This draft
guidance is intended to support the conduct of randomized controlled
drug trials with streamlined protocols and procedures that focus on
essential data, allowing integration of research into routine clinical
practice. Depending on the condition and the intervention to be
studied, the spectrum of trial designs may range from those that are
almost completely reliant on data acquired by the participant's local
healthcare providers during routine clinical practice visits to those
that require significant supplementation with dedicated, research-
specific activities for data collection conducted by trial staff.
Traditional randomized controlled drug trials typically capture a
large amount of protocol-specified patient information (e.g., patient
characteristics, medical history, concomitant medications, vital signs,
adverse events, laboratory results, measures of drug response, clinical
status) at baseline and over the course of the trial. Some of these
data are also collected in routine clinical practice, although the
specific procedures and methods, timing of collection, and
documentation formats typically differ from those in a clinical trial.
Given the potential overlap in information collected, data for clinical
research can, under appropriate circumstances, be obtained from routine
clinical practice interactions, reducing the need for dedicated trial
sites.
This draft guidance applies to studies involving FDA-approved drugs
being studied for new indications, populations, or doses; drug safety
studies for FDA-approved drugs; other postmarketing studies;
comparative effectiveness studies; and trials of unapproved drugs in
later development when the safety profile is sufficiently characterized
and the drug is appropriate to be administered and managed in the
setting of routine clinical practice. This guidance does not address
non-interventional (observational) studies.
Among other things, the draft guidance provides considerations
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regarding the roles and responsibilities of sponsors, investigators,
healthcare institutions, and local healthcare providers and addresses
using a quality by design approach to facilitate the conduct of trials
in the clinical practice setting.
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 ``Integrating
Randomized Controlled Trials for Drug and Biological Products Into
Routine Clinical Practice.'' 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
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR parts 50 and 56 have been approved under OMB control number
0910-0130; 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 <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: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21077 Filed 9-17-24; 8:45 am]
BILLING CODE 4164-01-P
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