[Federal Register Volume 84, Number 187 (Thursday, September 26, 2019)]
[Notices]
[Pages 50848-50849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20935]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3935]
International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on
General Considerations for Clinical Trials; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting entitled ``International Council on Harmonisation
(ICH) Global Meeting on E8(R1) Guideline on General Considerations for
Clinical Trials.'' The purpose of the public meeting is to provide
information on the draft revised E8(R1) Guideline ``General
Considerations for Clinical Trials'' (ICH E8 Guideline) following the
closing of the FDA comment period and closing of the regional
consultations conducted in other ICH regions. The ICH E8 Guideline is
being revised to provide updated guidance that is both appropriate and
flexible enough to address the increasing diversity of clinical trial
designs and data sources being employed to support regulatory and other
health policy decisions, while retaining the underlying principles of
human subject protection and data quality.
DATES: The public meeting will be held on Thursday, October 31, 2019,
from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the
Great Room), Silver Spring, MD 20993-0002. The meeting will also be
broadcast on the web, allowing participants to join in person or via
the web. For those who will attend in person, the entrance for the
public meeting participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. For those who register to attend the public meeting
remotely via the webcast, a link to access the webcast will be emailed
in advance of the meeting.
FOR FURTHER INFORMATION CONTACT: Amanda Roache, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993-0002, 301-
796-4548, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The ICH was established in 1990 as a joint regulatory/industry
project to improve, through harmonization, the efficiency of the
process for developing and registering new medicinal products in
Europe, Japan, and the United States without compromising the
regulatory requirements for safety and effectiveness. One of the goals
of harmonization is to identify and then reduce regional differences in
technical regulatory requirements for pharmaceutical products while
preserving a consistently high standard for drug efficacy, safety, and
quality. This is accomplished through the development of
internationally harmonized guidelines developed through a process of
scientific consensus with regulatory and industry experts. FDA
participates in ICH as a founding member and implements all ICH
guidelines as FDA guidance.
In 2015, ICH was reformed to establish it as a true global
initiative and to expand beyond the previous ICH members. More
involvement from regulators around the world is expected, as they join
counterparts from Europe, Japan, the United States, Canada, and
Switzerland as ICH regulatory members and observers. Expanded
involvement is also anticipated from global regulated pharmaceutical
industry parties, joining as ICH industry members and observers. The
reforms built on a 25-year track record and have allowed ICH to
continue its successful delivery of harmonized guidelines for global
pharmaceutical development and their regulation.
The ICH E8 Guideline sets out general principles on the conduct of
clinical trials, was adopted in 1997, and has not undergone revision.
Since its adoption, clinical trial design and conduct have become more
complex, impacting the time and cost required to develop drugs. A wide
range of both trial designs and data sources play a role in drug
development and are not adequately addressed in the original ICH E8
Guideline. Approaches are needed for
[[Page 50849]]
optimizing trial quality, which promote the reliability, efficiency,
and patient focus of clinical trials. This involves identifying the
factors that are critical to the quality of a clinical trial at the
design stage and planning the trial conduct proportionate to the risks
to these quality factors, thereby protecting human subjects and
ensuring the reliability of trial results. To resolve these issues, the
ICH Assembly initiated a revision of the ICH E8 Guideline in November
2017 to provide updated guidance that is both appropriate and flexible
enough to address the increasing diversity of clinical trial designs
and data sources being employed to support regulatory and other health
policy decisions, while retaining the underlying principles of human
subject protection and data quality.
II. Topics for Discussion at the Public Meeting
The draft revised ICH E8 Guideline was endorsed by the ICH Assembly
in May 2019 and made available for public comment. In the Federal
Register of August 1, 2019 (84 FR 37649), FDA published a notice
announcing the availability of a draft guidance entitled ``E8(R1)
General Considerations for Clinical Studies'' (ICH E8(R1) Guideline)
(available at https://www.fda.gov/media/129527/download). The notice
gave interested persons an opportunity to submit comments by September
30, 2019. As part of a broader outreach process, ICH is holding public
meetings before the finalization of the revised ICH E8(R1) Guideline.
One of these public meetings will be hosted by FDA in Silver Spring,
MD, on October 31, 2019 (see DATES and ADDRESSES). The purpose of the
public meeting is to provide an overview of the new concepts presented
in the revised ICH E8(R1) Guideline, allow for stakeholders who will be
affected by the revised guideline to share their perspective, and allow
for public input.
Public consultation is a standard part of all ICH guideline
development, and it is conducted within each region of ICH Regulatory
Members who commit to adoption of the finalized ICH guideline. This
meeting is part of the ICH ``Good Clinical Practice (GCP) Renovation''
strategy to update the ICH guidelines related to clinical trial design,
planning, management, and conduct, starting with the revision of the
ICH E8 Guideline and followed by the revision of the ICH E6 Guideline
for Good Clinical Practice. For more information, see the document
``ICH Reflection on `GCP Renovation': Modernization of ICH E8 and
Subsequent Renovation of ICH E6,'' available at https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Reflection_Papers/ICH_Reflection_paper_GCP_Renovation_Jan_2017_Final.pdf.
III. Participating in the Public Meeting
Registration: Persons interested in attending this public meeting
must register online by October 25, 2019, 11:59 p.m. Eastern Time. To
register for the public meeting, please visit the following website:
https://globalichmeeting_e8r1_2019_americas.eventbrite.com. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization.
The agenda for the public meeting is available on the internet and
can be viewed at the following link: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/ich-global-meeting-ich-e8r1-guideline-general-considerations-clinical-trials-10312019-10312019.
If you need special accommodations due to a disability, please
contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) no later
than October 18, 2019.
Requests for Oral Presentations: If you wish to make a presentation
during the public comment session, please contact Amanda Roache (see
FOR FURTHER INFORMATION CONTACT) no later than October 18, 2019.
Presentation slots may be limited and will be granted on a first-come,
first-served basis. Any public presentations should be limited to 5
minutes or less. Individuals and organizations with common interests
are urged to consolidate or coordinate their presentations and request
time for a joint presentation. If selected for presentation, any
presentation materials must be emailed to Amanda Roache (see FOR
FURTHER INFORMATION CONTACT) no later than October 24, 2019. No
commercial or promotional material will be permitted to be presented or
distributed at the public meeting. Signup for making a public comment
during the meeting will also be available between 8 a.m. and 8:30 a.m.
on the day of the meeting.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast through the following link: https://collaboration.fda.gov/ich103119/. To register to attend via webcast,
please visit the following website: https://globalichmeeting_e8r1_2019_americas.eventbrite.com.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Dated: September 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20935 Filed 9-25-19; 8:45 am]
BILLING CODE 4164-01-P