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Activity Outline
FDA Grand Rounds: ’Uncertainty is the only certainty there is’: Potential approaches for making public health decisions
April 11, 2019
WO32: 1243
FDA Grand Rounds: ’Uncertainty is the only certainty there is’: Potential approaches for making public health decisions
April 11, 2019
WO32: 1243
Activity Coordinator:
Devin Thomas (Devin.Thomas@fda.hhs.gov)
Series Description
The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.
Lecture Description
In 2012, CBER was reviewing the submission for the first home-use HIV test kit. Many important questions were discussed including: What is the sensitivity and specificity of the test? Who was likely to use it? Would people switch from professional testing to home-use testing? Would early detection with test reduce HIV transmission? Formal benefit-risk assessment was used to address these questions and the results of the analysis were presented to the Blood Products Advisory Committee.
Many important public health decisions face these kinds of uncertainty and yet the decisions still must be made. We must frequently consider data and analyses from disparate sources, including randomized clinical trials, large observational studies, reported international experience, passive surveillance, case studies, animal studies and more when making a decision for product approval or regulatory policy. Formal benefit-risk assessment approaches can help decision-makers understand how the key sources of uncertainty affect their decisions and help to integrate different types of data and analyses in their deliberations. A benefit-risk assessment framework can serve as the foundation for communication strategies both among the decision-makers and with the broader community of stakeholders. This lecture will introduce key benefit-risk assessment concepts and tools and show examples where formal benefit-risk assessment has supported difficult public health decisions.
In 2012, CBER was reviewing the submission for the first home-use HIV test kit. Many important questions were discussed including: What is the sensitivity and specificity of the test? Who was likely to use it? Would people switch from professional testing to home-use testing? Would early detection with test reduce HIV transmission? Formal benefit-risk assessment was used to address these questions and the results of the analysis were presented to the Blood Products Advisory Committee.
Many important public health decisions face these kinds of uncertainty and yet the decisions still must be made. We must frequently consider data and analyses from disparate sources, including randomized clinical trials, large observational studies, reported international experience, passive surveillance, case studies, animal studies and more when making a decision for product approval or regulatory policy. Formal benefit-risk assessment approaches can help decision-makers understand how the key sources of uncertainty affect their decisions and help to integrate different types of data and analyses in their deliberations. A benefit-risk assessment framework can serve as the foundation for communication strategies both among the decision-makers and with the broader community of stakeholders. This lecture will introduce key benefit-risk assessment concepts and tools and show examples where formal benefit-risk assessment has supported difficult public health decisions.
References
- Comparative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccines Among US Medicare Beneficiaries in Preventing Post influenza Deaths During 2012–2013 and 2013–2014
- Surveillance for Guillain–Barre Syndrome After Influenza Vaccination Among the Medicare Population, 2009–2010
Series Objectives
- Discuss the research conducted at the FDA
- Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
- Discuss the risk-benefit assessment concepts and tools for FDA-approved products
- Discuss the methods by which regulatory decisions are made in the face of uncertainty regarding subsequent outcomes
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
Agenda
Lecture 1 April 11, 2019
Lecture 1 April 11, 2019
| Time | Topic | Speaker |
|---|---|---|
| 12:00 - 1:00 PM EDT | ’Uncertainty is the only certainty there is’: Potential approaches for making public health decisions | Richard Forshee, PhD |
Continuing Education Accreditation
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-012-L04-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit
Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.
Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.
Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure
Faculty
Planning Committee
CE Consultation and Accreditation Team
Faculty
- Forshee, Richard, PhD, Deputy Director, Office of Biostatistics and Pharmacovigilance, FDA/CBER/OBPV - nothing to disclose
Planning Committee
- Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
- KEMPF, LUCAS, MD - nothing to disclose
- Lee, Christine, PhD, PharmD, General Health Scientist, FDA - nothing to disclose
- Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
- Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose
CE Consultation and Accreditation Team
- Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Information
Registration is complimentary; therefore refunds are not applicable.
Registration is complimentary; therefore refunds are not applicable.
U.S. Food and Drug Administration