Pharmacovigilance Activities

A dish full of pillsThe Safety Working Group coordinates the centralised trial safety monitoring. The Group’s role is to collate safety information from the various trials centrally in order to continuously monitor safety and detect safety signals in a timely manner.   Specific objectives are:

  1. To ensure standardized methods of collecting suspected adverse event information across the different trials by developing template SOPs and reporting forms;
  2. To use the pooled safety data from the trials for the identification and evaluation of safety signals;
  3. To provide supporting information to the trial’s Data Safety Monitoring Boards (DSMBs),  Consortium Partners and Research Ethic Committees (RECs);
  4. To define the process for communicating safety concerns through the MiP Consortium;
  5. To receive and review applications for access to derivative data contained within the Central Safety Database.

The Secretariat of the Safety Working Group is based within the MiP Consortium Secretariat. The members of the Safety Working Group are listed below:

  1. Andy Stergachis (Chair), University of Washington, USA;
  2. Esperanca Sevene (Vice Chair), Eduardo Mondlane University, Mozambique;
  3. Cheryl Pace (Secretariat), Liverpool School of Tropical Medicine, UK;
  4. Stephanie Dellicour (Secretariat), Liverpool School of Tropical Medicine, UK;
  5. Umberto d’Alessandro, Prince Leopold Institute of Tropical Medicine, Antwerp/Theonest Mutabingwa, Seattle Biomedical Research Institute, USA
  6. Daniel Chandramohan, London School of Hygiene and Tropical Medicine, UK
  7. Laurence Slutsker/Meghna Desai/Julie Gutman, Centre of Disease Control, USA
  8. Clara Menendez/Raquel Gonzales, Barcelona Centre for International Health Research (CRESIB), Spain
  9. Harry Tagbor, London School of Hygiene and Tropical Medicine, UK
  10. Linda Kalilani, Malawi
  11. Sarah Hanieh, Papua New Guinea
  12. Francois Nosten, Shoklo, Thailand
  13. Observers: Previous Safety Working Group members invited and others with interest in Safety Working Group activities

Project Activities:

  1. Established the Independent Safety Panel (described below).
  2. Developed standard operating procedures and proposed standardized forms for the reporting of adverse events across MiP Consortium studies. 
  3. Established the centralized pharmacovigilance database and reporting system (described below)
  4. Developed training materials, procedures and forms for pregnancy outcome and infant assessments to enhance standardization across sites for MiP Consortium partners.
  5. Submitted a proposal for MiP Consortium carry-forward funds to develop and field-test active surveillance tools and procedures and contribute safety information to the evidence database on the relationship between the use of ACTs during early pregnancy and the risk of adverse pregnancy outcomes.

Independent Safety Panel:

An Independent Safety Panel has been appointed to independently safeguard the interests of trial participants, assess the aggregate safety data across the MiP trials and to advise the Safety Working Group and the Executive Committee.

The Independent Safety Panel consists of 7 members who are impartial and independent to the studies. The Independent Safety Panel includes experts in or representatives of the fields of: statistics, epidemiology (perinatal), pharmacology, teratology/toxicology, pharmacovigilance, ethics and experience of trials in developing countries.

Table of Independent Safety Panel Members

Name

Affiliation

1.Sir Alasdair Breckenridge (Chairman)

Chairman, Medicines and Healthcare Product Regulatory Agency, UK

2. Dr Alex Dodoo

Centre for Tropical Clinical Pharmacology & Therapeutics, University of Ghana Medical School, Korle-Bu Teaching Hospital, Accra, Ghana

3. Dr Elisabeth Elefant

CRAT Hôpital Trousseau, Paris, France

4. Dr Bernard Nahlen

USAID, PMI, Washington, USA

5. Prof Thomas Smith

Biostatistics and Basic Epidemiology research group at the Swiss Tropical Institute, Switzerland

6. Prof  Godfrey B. Tangwa

University of Yaounde 1, Cameroon

7.  Dr  Zul Premji

Muhimbili University College of Health Sciences, Dar es Salaam, Tanzania

Centralised Safety Database for MiP Consortium Trials:

The centralized drug safety database for the MiP Consortium is housed at the Liverpool School of Tropical Medicine. The system uses dedicated drug safety software system from Phase Forward (‘Empirica Trace’) designed to allow accurate, timely and complete reporting of adverse events. The database incorporates MedDRA (the Medical Dictionary for Regulatory Activities) to code medical terms and ATC codes for drugs. The web-based system provides a single, modern solution for adverse event management according to international and regulatory standards.