CBERs Mini-Sentinel Protocol Based Evaluations Michael D Nguyen - - PowerPoint PPT Presentation

▶
cber s mini sentinel protocol based evaluations
SMART_READER_LITE
LIVE PREVIEW

CBERs Mini-Sentinel Protocol Based Evaluations Michael D Nguyen - - PowerPoint PPT Presentation

Aug 13, 2022 245 likes •350 views

CBERs Mini-Sentinel Protocol Based Evaluations Michael D Nguyen Division of Epidemiology Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research (CBER) Food and Drug Administration January 31, 2013 Role of

slide-1
SLIDE 1

CBER’s Mini-Sentinel Protocol Based Evaluations

Michael D Nguyen Division of Epidemiology Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research (CBER) Food and Drug Administration January 31, 2013

slide-2
SLIDE 2

2

Role of Protocol Based Evaluations

  • Best evidence to assess the safety of medical products
  • Assess safety on a population level
  • Sophisticated analytic methods
  • Exposures and outcomes validated by medical records
  • Enables FDA to conduct independent safety studies
  • Large, nationwide, multi-site surveillance population
  • Prospectively monitor safety of new products after licensure
  • Evaluate populations not studied clinical trials (e.g. pregnancy)
  • Pandemic response
  • Complements existing systems (AERS and VAERS)
slide-3
SLIDE 3

3

PRISM Protocol Based Studies

Surveillance Study Anticipated Protocol Posting Date Anticipated Final Study Report Posting Date 1 Rotavirus vaccines and intussusception Posted 10/24/11 Fall 2013 2 Gardasil and venous thromboembolism Posted 3/30/12 Winter 2013/14 3 Influenza vaccines and febrile seizures Posted 1/25/13 Spring 2014 4 5 6 7

slide-4
SLIDE 4

4

PRISM Protocol Based Studies

Surveillance Study Anticipated Protocol Posting Date Anticipated Final Study Report Posting Date 1 Rotavirus vaccines and intussusception Posted 10/24/11 Fall 2013 2 Gardasil and venous thromboembolism Posted 3/30/12 Winter 2013/14 3 Influenza vaccines and febrile seizures Posted 1/25/13 Spring 2014 4 Influenza vaccines and miscarriages Summer 2013 TBA 5 Influenza vaccines and cleft lip and palate Summer 2013 TBA 6 Influenza real-time safety surveillance Summer 2013 TBA 7 Prevnar 13 and Kawasaki Disease Spring 2014 TBA

slide-5
SLIDE 5

5

BloodSCAN Protocol Based Studies

Surveillance Study Anticipated Protocol Posting Date Anticipated Final Study Report Posting Date 1 Intravenous immunoglobulins and thromboembolic events Winter 2013/14 TBA

slide-6
SLIDE 6

6

Frequently Asked Questions

  • How does CBER select what to study?
  • Questions emerging from FDA licensure process (i.e. pharmacovigilance

planning)

  • Address questions from other sources and surveillance systems
  • Better define risk using Mini-Sentinel’s large population
  • Does CBER plan to conduct chart review?
  • Yes, currently planned for all CBER protocol based studies
slide-7
SLIDE 7

7

Frequently Asked Questions, cont.

  • How does CBER coordinate with other Federal Partners?
  • Routinely interface with Centers for Disease Control and Prevention,

Department of Defense, Centers for Medicaid and Medicare, etc.

  • Coordinate through Immunization Safety Task Force and National

Vaccine Program Office

  • Share resources and work collaboratively (e.g. CDC Vaccine Safety

Datalink)

slide-8
SLIDE 8

8

Plans for Transparency

  • Post all study protocols online
  • Public comment period
  • Notify manufacturers of protocol postings
  • Post final study reports online
  • Present at public federal advisory committees
  • Publish findings in medical literature
slide-9
SLIDE 9

9

Acknowledgements

  • Robert Ball
  • David Martin
  • Craig Zinderman
  • Richard Platt
  • Grace Lee
  • Meghan Baker
  • Lesley Curtis
  • All Mini-Sentinel Data Partners
  • PRISM and BloodSCAN Teams