2023-16544. Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies.” This public meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated in response to the COVID–19 pandemic. The public meeting will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI) to bring the clinical research community together to discuss a variety of topics related to mitigating disruptions of clinical studies of medical products during disasters and public health emergencies (PHEs). The meeting format will include presentations and panel discussions.

DATES:

The public meeting will be held virtually on October 18 and 19, 2023, from 10 a.m. to 1:30 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The public meeting will be held virtually using the Zoom platform. The link for the public meeting will be sent to registrants upon registration.

FOR FURTHER INFORMATION CONTACT:

Dat Doan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240–402–8926, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

This public meeting satisfies FDA's mandate under section 3605 of FDORA to convene a public meeting, not later than 180 days after the date when the COVID–19 emergency period ends, to discuss the recommendations provided by FDA during the COVID–19 emergency period to mitigate disruption of clinical studies. Among other things, the public meeting will include discussion about strategies for mitigating disruptions of clinical studies of medical products during disasters and PHEs.

II. Topics for Discussion at the Public Meeting

Topics for discussion during this meeting include:

1. The recommendations provided by FDA during the COVID–19 emergency period to mitigate disruption of clinical studies, including recommendations detailed in the guidance for industry, investigators, and institutional review boards entitled “Conduct of Clinical Trials of Medical Products During the COVID–19 Public Health Emergency ^[1] ” (March 2020, updated August 2021)

2. The actions sponsors took to utilize such recommendations and the frequency at which such recommendations were utilized

3. The characteristics of the sponsors, studies, and patient populations impacted by such recommendations

4. Consideration of how recommendations intended to mitigate disruption of clinical studies during the COVID–19 emergency period, including any recommendations to consider decentralized clinical studies when appropriate, may have affected access to clinical studies for certain patient populations, especially underrepresented racial and ethnic minorities

5. Recommendations for incorporating certain clinical study disruption mitigation recommendations into current or additional guidance to improve clinical study access and enrollment of diverse patient populations

6. Strategies for advanced planning to mitigate disruption of clinical studies during future disasters and PHEs

III. Participating in the Public Meeting

Registration: To register for the public meeting, please visit the following website: duke.zoom.us/meeting/register/tJAvcO-oqD4vE9Ov1Vv-A3SoItVhL7Rhg66T. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free, and persons interested in attending this public meeting must register to receive a link to the meeting. Registrants will receive a confirmation email after they register.

If you need special accommodations due to a disability, please contact [e-mail] no later than October 4, 2023. Please note, closed captioning will be available automatically.

Dated: July 31, 2023.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  Available at: https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency.