[Project summary in Français / Português]
Scientific title: A Drug Safety Database for the ACT Consortium
The database currently holds over 3000 safety reports from malaria studies, 900 of which are from studies within the ACT Consortium, comprising serious and non-serious adverse events, collected by both clinicians and non-clinicians.
In addition to the data contributed by the ACT Consortium, the database continues to grow with reports being contributed from other sources. The database undergoes continuous monitoring for potential safety issues. So far, no specific concerns with ACT drugs have arisen
The infrastructure for safety data collation from a variety of sources has been established and discussions have been held with partners outside of the Consortium to develop collaborations for the future use of this resource.
All medicines have a balance between their benefits and harms, regardless of which condition they are used to treat or which setting they are used in. However, there is little knowledge about the harms associated with the long term use of ACT drugs in comparison with the benefits.
Clinical trials and real life experience to date have indicated that this group of medicines is safe and effective, and there is no evidence to suggest concern with their rapidly increasing use over the past few years.
Nevertheless, safety data on ACT drugs are limited and most of the current data are based on trials where patients took the medicine only once. Also, until recently the majority of these drugs had been used by adults in areas of low malaria transmission – such as South-East Asia – where patients are unlikely to be treated more than once a year. Since the wider implementation of ACT in national control programmes in Africa, the average child in Sub-Saharan Africa may be treated three or more times a year. These settings are therefore more likely to reveal issues of safety of ACT drugs when used repeatedly.
National programmes in Africa and Asia currently lack the infrastructure to implement a scheme that reports unpredicted side effects of drugs (known as adverse drug reaction or ADR).
This study aims to collect safety data from studies within the ACT Consortium to identify possible unknown harms related to the drugs. It also aims todetermine the incidence of known adverse drug reactions and to assess risk factors associated with potential safety issues. The project team has invested in a professional software to manage adverse events, which enables collation and analysis of the safety data generated by studies within the ACT Consortium. Data has been collected by clinicians and non-clinicians by applying data collection tools developed by the Consortium. These are aimed at standardising data collection to assist the process of pooling of data, which in turn increases our ability to identify safety issues.
By encouraging and assisting non-clinicians to collect safety data, we are strengthening the capacity for data collection in countries with limited resources, as well asincreasing the quantity and quality of data being contributed to the database.
Once we complete the data collection, the database will undergo a final analysis to contribute to the safety profile of ACT drugs, which is currently imited.
The database can also be extended to other drugs and diseases, and could be useful resource forresearchers and other interested parties for monitoring adverse event data from outside of the ACT Consortium.
Emma C. Davies, Clare I. R. Chandler, Simeon H. S. Innocent, Charles Kalumuna, Dianne J. Terlouw, David G. Lalloo, Sarah G. Staedke, Ane Haaland | Published