Operational lessons learned in conducting an international study on pharmacovigilance in pregnancy in resource-constrained settings: The WHO Global Vaccine safety Multi-Country collaboration project
Apoorva Sharan,
Shubhashri Jahagirdar,
Anke L Stuurman,
Varalakshmi Elango,
Margarita Riera-Montes,
Neeraj Kumar Kashyap,
Narendra Kumar Arora,
Mathews Mathai,
Punam Mangtani,
Hugo Devlieger,
Steven Anderson,
Barbee Whitaker,
Hui-Lee Wong,
Clare L Cutland,
Christine Guillard Maure
Affiliations
Apoorva Sharan
The INCLEN Trust International, New Delhi, India; Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland; University of Basel, Basel, Switzerland
Shubhashri Jahagirdar
The INCLEN Trust International, New Delhi, India
Anke L Stuurman
P95 Pharmacovigilance and Epidemiology, Leuven, Belgium
Varalakshmi Elango
P95 Pharmacovigilance and Epidemiology, Leuven, Belgium
Margarita Riera-Montes
P95 Pharmacovigilance and Epidemiology, Leuven, Belgium
Neeraj Kumar Kashyap
The INCLEN Trust International, New Delhi, India
Narendra Kumar Arora
The INCLEN Trust International, New Delhi, India
Mathews Mathai
Centre for Maternal and Newborn Health, Liverpool School of Tropical Medicine, Liverpool, UK
Punam Mangtani
Department of Infectious Disease Epidemiology, London School of Tropical Medicine, London, UK
Hugo Devlieger
Universitair Ziekenhuis, Leuven, Belgium
Steven Anderson
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA
Barbee Whitaker
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA
Hui-Lee Wong
Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA
Clare L Cutland
African Leadership in Vaccinology Expertise (Alive), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
Christine Guillard Maure
Department of Regulation and Prequalification, World Health Organization, Geneva, Switzerland; Corresponding author at: Department of Essential Medicines and Health Products, World Health Organization (WHO), Avenue Appia 20, 1202 Geneva, Switzerland.
The WHO Global Vaccine Safety Multi-Country Collaboration study on safety in pregnancy aims to estimate the minimum detectable risk for selected perinatal and neonatal outcomes and assess the applicability of standardized case definitions for study outcomes and maternal immunization in low- and middle-income countries (LMICs). This paper documents the operational lessons learned from the study.A prospective observational study was conducted across 21 hospitals in seven countries. All births occurring at sites were screened to identify select perinatal and neonatal outcomes from May 2019 to August 2020. Up to 100 cases per outcome were recruited to assess the applicability of standardized case definitions. A multi-pronged study quality assurance plan was implemented. The impact of the COVID-19 pandemic on site functioning and project implementation was also assessed.Multi-layered ethics and administrative approvals, limited clinical documentation, difficulty in identifying outcomes requiring in-hospital follow-up, and poor quality internet connectivity emerged as important barriers to study implementation. Use of electronic platforms, application of a rigorous quality assurance plan with frequent interaction between the central and site teams helped improve data quality. The COVID-19 pandemic disrupted data collection for up to 6 weeks in some sites.Our study succeeded in establishing an international hospital-based surveillance network for evaluating perinatal and neonatal outcomes using common study protocol and procedures in geographically diverse sites with differing levels of infrastructure, clinical and health-utilization practices. The enhanced surveillance capacity of participating sites shall help support future pharmacovigilance efforts for pregnancy interventions.
