strategic initiatives

Special COVID-19 Sessions

 

International collaboration on real-world evidence in COVID-19
Date: November 24, 2020
Time: 9:00 – 10:00 am EST

Speaker: Dr. Peter Arlett, European Medicines Agency
Since the declaration of COVID-19 as a pandemic there has been an explosion of real-world evidence (RWE) publications. Many of these publications have been based on small populations, methodological vigour has not always been optimal and the quality of reporting, including results being made public prior to peer-review, has often made interpreting the results difficult. International regulatory collaboration on RWE studies about COVID-19 has the potential to increase the size of populations being studied and to increase methodological vigour and quality of reporting through sharing of expertise.

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Description of COVID-19 patients’ characteristics
Date: October 29, 2020
Time: 9:00 – 10:00 am EDT

Moderator: Stephen Schachterle

  • The Danish COVID-19 cohort: Results from an academia-regulator collaboration.
    • Anton Pottegård, University of Southern Denmark, Odense, Denmark
  • Measuring the Impact of the COVID-19 pandemic on drug utilization in Ontario, Canada.
    • Mina Tadrous, Women's College Hospital, Toronto, Canada
  • Clinical characteristics of suspected and confirmed COVID-19 in the United Kingdom Clinical Practice Research Datalink (CPRD) databases.
    • Tarita Murray-Thomas, CPRD, MHRA, London, United Kingdom
  • Characterization of Patients Hospitalized with COVID-19 Using a Large U.S. Electronic Health Record Data Repository.
    • Caihua Liang, Optum Epidemiology, Boston, USA

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Outcomes in patients with COVID-19
Date: November 6, 2020
Time: 9:00 – 10:00 am EST

Moderators: Ann McMahon and Montse Soriano-Gabarro

  • Clinical Outcomes During COVID-19 Hospitalization: A Retrospective Cohort Study Comparing Immunocompromised to Immunocompetent Persons.
    • Kathleen M. Andersen, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA. Center for Drug Safety and Effectiveness, Baltimore, USA
  • Risk factors for COVID-related death among 27 million U.S. Medicare Beneficiaries.
    • Hector S. Izurieta, US Food and Drug Administration, Silver Spring, USA
  • Natural History of Coagulopathy in Patients with COVID-19 in a Real-World Electronic Health Data Network.
    • Maria Kempner, Harvard Pilgrim Health Care Institute, Boston, USA, Harvard Medical School, Boston, USA
  • Examining adverse outcomes and monthly trends in pediatric and adult patients with COVID-19: a real world evidence study.
    • Sierra Luciano, TriNetX, Inc., Cambridge, USA

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Race, gender, disparities, social isolation, and social distancing
of COVID-19
Date: November 30, 2020
Time: 9:00 – 10:00 am EST

Moderator: TBD

  • Sex differences in adverse drug reaction reporting revealed in a global database of spontaneous reports for COVID-19 drugs.
    • Alem Zekarias, Uppsala Monitoring Centre, Uppsala, Sweden
  • The Influence of Social Distancing on COVID-19 Infections in the U.S.
    • Paul Coplan, Johnson and Johnson, New Brunswick, NJ, USA
  • Mitigating the mental health impact of social isolation in older adults during outbreaks and COVID19: A rapid review of real-world interventions.
    • Amalia Issa, University of the Sciences in Philadelphia, Philadelphia, USA
  • Evaluation of Racial/Ethnic Disparities in COVID-19 Clinical Care and Outcomes – a Real-World Data Analysis.
    • Ami Buikema, Optum, Eden Prairie, USA

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Specific Treatment-outcome association studies of COVID-19
Date: December 1, 2020
Time: 9:00 – 10:00 am EST

Moderators: Ann McMahon

  • Clinical Outcomes From COVID-19 Following Use of Angiotensin-Converting Enzyme Inhibitors or Angiotensin-Receptor Blockers Among Patients with Hypertension in South Korea: A nationwide study.
    • Ju Hwan Kim, Sungkyunkwan University, Suwon, Korea, Republic of
  • Adverse outcomes and mortality in users of non-steroidal anti-inflammatory drugs who tested positive for SARS-CoV-2: A Danish nationwide cohort study.
    • Lars Christian Lund, University of Southern Denmark, Odense, Denmark
  • Renin-angiotensin-aldosterone system inhibitors and COVID-19 infection or hospitalization: a cohort study.
    • Sascha Dublin, Kaiser Permanente Washington Health Research Institute, Seattle, USA, Department of Epidemiology, University of Washington, Seattle, USA
  • Inhaled corticosteroid use and risk of COVID-19 related death among 967,047 patients with COPD or asthma: an OpenSAFELY analysis
    • Anna Schultze, London School of Hygiene and Tropical Medicine, London, United Kingdom

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Algorithm, model, methods of COVID-19
Date: December 3, 2020
Time: 9:00 – 10:00 am EST

Moderator: Xiaojuan Li

  • Living systematic benefit-risk assessments for COVID-19 treatments: Establishing a dynamic framework for rapid decision-making.
    • Miranda Davies, Drug Safety Research Unit, Southampton, United Kingdom
  • Comparing Methodologies to Predict Incidence of COVID-19 in US Counties.
    • Paul Coplan, Johnson and Johnson, New Brunswick, NJ, USA
  • Validation of claims-based algorithms to identify hospitalized COVID-19 events within the Sentinel System.
    • Sheryl Kluberg, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
  • A COVID-19 epidemiologic model to enhance trial efficiency through evidence-based site selection for SARS-COV-2 vaccine trials.
    • Debra Schaumberg, Evidera

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