Collecting safety data in antimalarial drug trials

During clinical trials, research teams use various information that participants tell them. These include the occurrence of new, possibly harmful or unpredicted side effects (known as adverse events or adverse drug reactions), the patients’ medical history and which other medicines they are taking.

Researchers are concerned that the way participants are questioned can influence what information they report, and therefore prevent an accurate assessment of the safety of the drugs used in clinical trials. However, the current scientific literature doesn’t include a standard method to best carry out the questioning or how the information is then assessed.

The questioning methods and the different trial contexts did appear to influence the collection of these important contributions to drug safety assessments. Consequently, there should be further work to investigate these influences and find appropriate questioning methods.

To contribute to this topic further the researchers conducted an online global survey of malaria researchers about the ways they question their participants about this information, and assess the results. The survey showed that various methods are being used, which could influence trial results. The best way for obtaining safety information from participants is unclear, therefore we propose that anti-malarial clinical researchers work towards consensus about the design of optimal methods.

This study also conducts a consensus-building process called a Delphi about these issues. This will be supported with results from a Cochrane systematic review of work in other diseases where different ways of questioning participants have been compared.

Drug-based Strategies
Surveillance

Nov 2009 — Sep 2013

$775,754

South Africa