Developing novel methods to study drug safety and effectiveness [email protected] McGill University Health Centre
DSECT/DSEN Seminar Series Invitation

DSECT/DSEN Seminar Series Invitation

Join the DSECT/DSEN Monthly Seminar Series!

DSECT/DSEN present monthly online seminars for faculty, staff, trainees, decision makers and other stakeholders engaged in drug safety and effectiveness.

This month’s presentation by Dr. Anick Berard will be Available medications used as potential therapeutics for COVID-19: What are the known safety profiles in pregnancy.

Date: May 27, 2021
Time: 3:00-4:00 pm EST

RSVP:https://register.gotowebinar.com/register/1457674650757216523

Medications already available to treat other conditions are presently being studied in clinical trials as potential treatments for COVID-19. Given that pregnant women are excluded from these trials, we aimed to investigate their safety when used during pregnancy within a unique population source.

Using the population-based Quebec Pregnancy Cohort, we identified women who delivered a singleton liveborn (1998-2015). Taking potential confounders into account including indications for use, the risk of prematurity, low birth weight (LBW), small for gestational age (SGA), and major congenital malformation (MCM) associated with COVID-19 repurposed drug use during pregnancy were quantified using generalized estimation equations.

The Drug Safety and Effectiveness Cross-Disciplinary Training (DSECT) Program “bridges biosciences, clinical therapeutics, population health, epidemiology, biostatistics, and health services and policy research to better understand choosing, using and losing medications within the context of medication safety and effectiveness.”

For more information, please visit their website: http://www.safeandeffectiverx.com/.

Presentation on the Drug Safety and Effectiveness Network (DSEN) Methods and Applications Group for Indirect Comparisons (MAGIC) Rapid Reviews and COVID-19

Join Ms. Shannon Kelly, Co-Investigator of DSEN MAGIC who currently manages and works as a senior research methodologist at the University of Ottawa Heart Institute for a presentation on rapid reviews on Monday November 9th 2:45-4:00pm EST. 

Participants will learn how to define rapid reviews, identify “how to” conduct rapid reviews, and identify methodological challenges of rapid review conduct during COVID-19. The case studies will include a rapid review of treatments for COVID-19 that was expanded and converted into a rapid scoping review, and a rapid scoping review on dose sparing strategies for the influenza vaccine. We will also discuss methodological challenges associated with the conduct of rapid reviews on COVID-19. 

Find out more: 2020 Canadian Agency for Drugs and Technologies in Health (CADTH) Symposium  

ICPE All Access Special COVID-19 Sessions

ISPE is excited to present the ICPE All Access Special COVID-19 Sessions. These 60-minute sessions will feature four presentations of 10 minutes in length with a Q&A period in the end.

These sessions are complimentary, you do not have to be registered for ICPE All Access to attend!

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 the sharing of expertise.

Register HERE

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

Register HERE

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

Register HERE

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

Register HERE

Specific Treatment-outcome association studies of COVID-19
Date: December 1, 2020 
Time: 9:00 – 10:00 am EST 
Moderators: Ann McMahon and Montse Soriano-Gabarro

  • 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

Register HERE

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
    Sonia Halhol, Evidera, Waltham, Canada

Register HERE

2020 Virtual CADTH Symposium

CADTH is pleased to announce that the 2020 Virtual CADTH Symposium will be held online on November 9 and 10. Additional content will be available on-demand, including an e-poster gallery. Additional workshops will be held throughout the fall, winter, and spring.

All content will be presented free of charge.

The CADTH Symposium is widely considered a “must attend” event for anyone with an interest in the assessment, uptake, and management of drugs and medical devices in Canada. We anticipate that online attendance for this year’s virtual event will exceed 1,500 delegates from across Canada and beyond. Attendees will include health researchers; health economists; senior leaders from government, regional health authorities, hospitals, and other facilities; clinicians and patients; students; and industry representatives. As one of the major health technology assessment conferences in the world, the CADTH Symposium offers a unique opportunity for delegates to learn from local, national, and international experts, and to share their own expertise and knowledge.

DSECT/DSEN Seminar Series Invitation

Join the DSECT/DSEN Monthly Seminar Series!

DSECT/DSEN present monthly online seminars for faculty, staff, trainees, decision makers and other stakeholders engaged in drug safety and effectiveness.

This month’s presentation by Dr. Andrea Tricco, Dr. Brian Hutton and Ms. Shannon Kelly will be DSEN MAGIC Rapid Reviews and COVID-19.

Date: October 22, 2020
Time: 3:00-4:00 pm EST

RSVP: https://attendee.gotowebinar.com/register/1884742558523811856

COVID-19 has driven the need for timely evidence to inform decision-making. In this webinar, we will discuss the importance of rapid reviews during COVID-19 and present case examples of how the MAGIC team responded to queries from DSEN policy-makers through rapid reviews. We will also discuss methodological challenges associated with the conduct of rapid reviews on COVID-19.

The Drug Safety and Effectiveness Cross-Disciplinary Training (DSECT) Program “bridges biosciences, clinical therapeutics, population health, epidemiology, biostatistics, and health services and policy research to better understand choosing, using and losing medications within the context of medication safety and effectiveness.”

For more information, please visit their website: http://www.safeandeffectiverx.com/.

Open for Applications: CIHR Drug Safety and Effectiveness Cross-Disciplinary Training (DSECT) Program

This training program bridges clinical therapeutics, active surveillance, administrative datasets, research methods, health services and policy, pharmaceutical policy, meta-analysis, and knowledge translation to better understand choosing, using, and losing medications within the context of drug safety and effectiveness.

The program offers opportunities for trainees across a broad spectrum of research areas to learn together and from each other as a key impetus for filling the critical void of skilled, knowledgeable researchers in the area of therapeutics.

For more information, visit DSECT’S website .

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